Journal articles: 'Process analytical technologies (PAT)'

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Patel, Sajal Manubhai, and Michael Pikal. "Process Analytical Technologies (PAT) in freeze-drying of parenteral products." Pharmaceutical Development and Technology 14, no. 6 (November 3, 2009): 567–87. http://dx.doi.org/10.3109/10837450903295116.

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Hinz, Dirk C. "Process analytical technologies in the pharmaceutical industry: the FDA’s PAT initiative." Analytical and Bioanalytical Chemistry 384, no. 5 (August 4, 2005): 1036–42. http://dx.doi.org/10.1007/s00216-005-3394-y.

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Grumbach, Carsten, and Peter Czermak. "Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices." Processes 10, no. 6 (June 10, 2022): 1174. http://dx.doi.org/10.3390/pr10061174.

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The good manufacturing practices (GMP) and process analytical technology (PAT) initiatives of the US Food and Drug Administration, in conjunction with International Council for Harmonisation (ICH) quality guidelines Q8, Q9, and Q10, ensure that manufacturing processes for parenteral formulations meet the requirements of increasingly strict regulations. This involves the selection of suitable process analytics for process integration and aseptic processing. In this article, we discuss the PAT requirements for the GMP-compliant manufacturing of parenteral lipid emulsions, which can be used for clinical nutrition or for the delivery of lipophilic active ingredients. There are risks associated with the manufacturing processes, including the potential for unstable emulsions and the formation of large droplets that can induce embolisms in the patient. Parenteral emulsions are currently monitored offline using a statistical approach. Inline analytics, supplemented by measurements of zeta potential, could minimize the above risks. Laser scanning technology, ultrasound attenuation spectroscopy, and photo-optical sensors combined with image analysis may prove to be useful PAT methods. In the future, these technologies could lead to better process understanding and control, thus improving production efficiency.

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Jensch, Christoph, Larissa Knierim, Martin Tegtmeier, and Jochen Strube. "Development of a General PAT Strategy for Online Monitoring of Complex Mixtures—On the Example of Natural Product Extracts from Bearberry Leaf (Arctostaphylos uva-ursi)." Processes 9, no. 12 (November 25, 2021): 2129. http://dx.doi.org/10.3390/pr9122129.

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For the first time, a universally applicable and methodical approach from characterization to a PAT concept for complex mixtures is conducted—exemplified on natural products extraction processes. Bearberry leaf (Arctostaphylos uva-ursi) extract is chosen as an example of a typical complex mixture of natural plant origin and generalizable in its composition. Within the quality by design (QbD) based process development the development and implementation of a concept for process analytical technology (PAT), a key enabling technology, is the next necessary step in risk and quality-based process development and operation. To obtain and provide an overview of the broad field of PAT, the development process is shown on the example of a complex multi-component plant extract. This study researches the potential of different process analytical technologies for online monitoring of different component groups and classifies their possible applications within the framework of a QbD-based process. Offline and online analytics are established on the basis of two extraction runs. Based on this data set, PLS models are created for the spectral data, and correlations are conducted for univariate data. In a third run, the prediction potential is researched. Conclusively, the results of this study are arranged in the concept of a holistic quality and risk-based process design and operation concept.

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O'Shea, Norah, Tom F. O'Callaghan, and John T. Tobin. "The application of process analytical technologies (PAT) to the dairy industry for real time product characterization - process viscometry." Innovative Food Science & Emerging Technologies 55 (July 2019): 48–56. http://dx.doi.org/10.1016/j.ifset.2019.05.003.

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Singha Roy, Pritha, Gaurab Joarder, Saibal Debnath, and Avisek Pahari. "A REVIEW OF THE INNOVATIVE DRYING TECHNOLOGIES FOR BIOPHARMACEUTICALS." International Journal of Advanced Research 10, no. 05 (May 31, 2022): 1100–1111. http://dx.doi.org/10.21474/ijar01/14820.

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Reviewing data from the previous twenty to twenty-five years reveals that bio-pharmaceuticals are a sudden, dramatic, and incredibly significant finding in progressively enhancing the quality of life for patients with different kinds of malignancies, auto-immune illnesses, genetic disorders, etc. Drying technologies are a required manufacturing step in the pharmaceutical industry/production unit, and an understanding of drying technologies and how to use them is now an absolute must. With the increased demand for biopharmaceuticals, it is essential to reduce production costs without sacrificing product safety, quality, or effectiveness. The predominant commercial method for generating solid biopharmaceuticals is batch freeze-drying. However, freeze-drying is expensive compared to other procedures and is not ideal for lengthy working hours, in addition to requiring a large initial capital investment and significant energy consumption, resulting in high total expenses. This article discusses innovative drying methods for parenteral biopharmaceuticals. Spin-freeze drying, spray drying, and LynfinityÂ® Technology enable continuous manufacturing, while PRINTÂ® Technology and MicroglassificationTM manage dry particle characteristics. As a consequence, certain drying processes may need less validation. Process Analytical Technology (PAT) and offline dramatisation may give extra information on CPPs and CQAs during biopharmaceutical manufacture. These processing approaches might boost biopharmaceutical product production while reducing expenses.

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Uhlenbrock, Lukas, Maximilian Sixt, Martin Tegtmeier, Hartwig Schulz, Hansjörg Hagels, Reinhard Ditz, and Jochen Strube. "Natural Products Extraction of the Future—Sustainable Manufacturing Solutions for Societal Needs." Processes 6, no. 10 (October 1, 2018): 177. http://dx.doi.org/10.3390/pr6100177.

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The production of plant-based extracts is significantly influenced by traditional techniques and the natural variability of feedstock. For that reason, the discussion of innovative approaches to improve the manufacturing of established products and the development of new products within the regulatory framework is essential to adapt to shifting quality standards. This perspective of members of the DECHEMA/ProcessNet working group on plant-based extracts outlines extraction business models and the regulatory framework regarding the extraction of traditional herbal medicines as complex extracts. Consequently, modern approaches to innovative process design methods like QbD (Quality by Design) and quality control in the form of PAT (Process Analytical Technology) are necessary. Further, the benefit of standardized laboratory equipment combined with physico-chemical predictive process modelling and innovative modular, flexible batch or continuous manufacturing technologies which are fully automated by advanced process control methods are described. A significant reduction of the cost of goods, i.e., by a factor of 4–10, and decreased investments of about 1–5 mil. € show the potential for new products which are in line with market requirements.

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Yokoyama, Reiji, Go Kimura, Christian Schlepütz, Jörg Huwyler, and Maxim Puchkov. "Modeling of Disintegration and Dissolution Behavior of Mefenamic Acid Formulation Using Numeric Solution of Noyes-Whitney Equation with Cellular Automata on Microtomographic and Algorithmically Generated Surfaces." Pharmaceutics 10, no. 4 (December 3, 2018): 259. http://dx.doi.org/10.3390/pharmaceutics10040259.

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Manufacturing parameters may have a strong impact on the dissolution and disintegration of solid dosage forms. In line with process analytical technology (PAT) and quality by design approaches, computer-based technologies can be used to design, control, and improve the quality of pharmaceutical compacts and their performance. In view of shortcomings of computationally intensive finite-element or discrete-element methods, we propose a modeling and simulation approach based on numerical solutions of the Noyes-Whitney equation in combination with a cellular automata-supported disintegration model. The results from in vitro release studies of mefenamic acid formulations were compared to calculated release patterns. In silico simulations with our disintegration model showed a high similarity of release profile as compared to the experimental evaluation. Furthermore, algorithmically created virtual tablet structures were in good agreement with microtomography experiments. We conclude that the proposed computational model is a valuable tool to predict the influence of material attributes and process parameters on drug release from tablets.

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Schmidt, Axel, Heribert Helgers, Florian Lukas Vetter, Alex Juckers, and Jochen Strube. "Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts." Processes 9, no. 11 (October 21, 2021): 1874. http://dx.doi.org/10.3390/pr9111874.

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SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process transfer for manufacturing capacity multiplication, a reduction in out-of-specification batch failures, qualified personal training for faster validation and efficient operation, optimal utilization of scarce buffers and chemicals and speed-up of product release by continuous manufacturing. In this work, three manufacturing concepts for mRNA-based vaccines are evaluated: Batch, full-continuous and semi-continuous. Technical transfer from batch single-use to semi-continuous stainless-steel, i.e., plasmid deoxyribonucleic acid (pDNA) in batch and mRNA in continuous operation mode, is recommended, in order to gain: faster plant commissioning and start-up times of about 8–12 months and a rise in dose number by a factor of about 30 per year, with almost identical efforts in capital expenditures (CAPEX) and personnel resources, which are the dominant bottlenecks at the moment, at about 25% lower operating expenses (OPEX). Consumables are also reduceable by a factor of 6 as outcome of this study. Further optimization potential is seen at consequent digital twin and PAT (Process Analytical Technology) concept integration as key-enabling technologies towards autonomous operation including real-time release-testing.

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Metze, S., S. Ruhl, G. Greller, C. Grimm, and J. Scholz. "Monitoring online biomass with a capacitance sensor during scale-up of industrially relevant CHO cell culture fed-batch processes in single-use bioreactors." Bioprocess and Biosystems Engineering 43, no. 2 (September 23, 2019): 193–205. http://dx.doi.org/10.1007/s00449-019-02216-4.

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Abstract In 2004, the FDA published a guideline to implement process analytical technologies (PAT) in biopharmaceutical processes for process monitoring to gain process understanding and for the control of important process parameters. Viable cell concentration (VCC) is one of the most important key performance indicator (KPI) during mammalian cell cultivation processes. Commonly, this is measured offline. In this work, we demonstrated the comparability and scalability of linear regression models derived from online capacitance measurements. The linear regressions were used to predict the VCC and other familiar offline biomass indicators, like the viable cell volume (VCV) and the wet cell weight (WCW), in two different industrially relevant CHO cell culture processes (Process A and Process B). Therefore, different single-use bioreactor scales (50–2000 L) were used to prove feasibility and scalability of the in-line sensor integration. Coefficient of determinations of 0.79 for Process A and 0.99 for Process B for the WCW were achieved. The VCV was described with high coefficients of determination of 0.96 (Process A) and 0.98 (Process B), respectively. In agreement with other work from the literature, the VCC was only described within the exponential growth phase, but resulting in excellent coefficients of determination of 0.99 (Process A) and 0.96 (Process B), respectively. Monitoring these KPIs online using linear regression models appeared to be scale-independent, enabled deeper process understanding (e.g. here demonstrated in monitoring, the feeding profile) and showed the potential of this method for process control.

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Evangelista, Chiara, Loredana Basiricò, and Umberto Bernabucci. "An Overview on the Use of Near Infrared Spectroscopy (NIRS) on Farms for the Management of Dairy Cows." Agriculture 11, no. 4 (March 30, 2021): 296. http://dx.doi.org/10.3390/agriculture11040296.

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Dairy farming is increasingly affected by the digital revolution. To respond to current challenges—such as environmental, economic, and social sustainability—new technologies must be adopted, entering the perspective of precision livestock farming. This is made possible by the development of countless sensors to be adopted in the barn. The technology that is affecting various aspects of dairy cattle breeding is certainly near infrared spectroscopy (NIRS) which is versatile and can be used online/inline to evaluate and control the critical points of the production process by entering the PAT (process analytical technology). In the barn, NIRS currently can obtain information on the chemical-physical composition of raw materials, total mixed ration (TMR), feces and digestibility, chemical and technological analysis of milk. All this in a short time by eliminating the waiting times for analysis response and costs, allowing an improvement of livestock management. Many studies affirm the validity of NIRS as a reliable and predictive technology against multiple relevant parameters in matrices such as raw feed, TMR, feces, and milk. This review highlights the usefulness of NIRS technology in dairy farm with particular attention to portable instrumentation usable directly on the farm.

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Chen, Yingjie, Ou Yang, Chaitanya Sampat, Pooja Bhalode, Rohit Ramachandran, and Marianthi Ierapetritou. "Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review." Processes 8, no. 9 (September 2, 2020): 1088. http://dx.doi.org/10.3390/pr8091088.

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The development and application of emerging technologies of Industry 4.0 enable the realization of digital twins (DT), which facilitates the transformation of the manufacturing sector to a more agile and intelligent one. DTs are virtual constructs of physical systems that mirror the behavior and dynamics of such physical systems. A fully developed DT consists of physical components, virtual components, and information communications between the two. Integrated DTs are being applied in various processes and product industries. Although the pharmaceutical industry has evolved recently to adopt Quality-by-Design (QbD) initiatives and is undergoing a paradigm shift of digitalization to embrace Industry 4.0, there has not been a full DT application in pharmaceutical manufacturing. Therefore, there is a critical need to examine the progress of the pharmaceutical industry towards implementing DT solutions. The aim of this narrative literature review is to give an overview of the current status of DT development and its application in pharmaceutical and biopharmaceutical manufacturing. State-of-the-art Process Analytical Technology (PAT) developments, process modeling approaches, and data integration studies are reviewed. Challenges and opportunities for future research in this field are also discussed.

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Trenfield, Sarah J., Patricija Januskaite, Alvaro Goyanes, David Wilsdon, Martin Rowland, Simon Gaisford, and Abdul W. Basit. "Prediction of Solid-State Form of SLS 3D Printed Medicines Using NIR and Raman Spectroscopy." Pharmaceutics 14, no. 3 (March 8, 2022): 589. http://dx.doi.org/10.3390/pharmaceutics14030589.

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Selective laser sintering (SLS) 3D printing is capable of revolutionising pharmaceutical manufacturing, by producing amorphous solid dispersions in a one-step manufacturing process. Here, 3D-printed formulations loaded with a model BCS class II drug (20% w/w itraconazole) and three grades of hydroxypropyl cellulose (HPC) polymer (-SSL, -SL and -L) were produced using SLS 3D printing. Interestingly, the polymers with higher molecular weights (HPC-L and -SL) were found to undergo a uniform sintering process, attributed to the better powder flow characteristics, compared with the lower molecular weight grade (HPC-SSL). XRPD analyses found that the SLS 3D printing process resulted in amorphous conversion of itraconazole for all three polymers, with HPC-SSL retaining a small amount of crystallinity on the drug product surface. The use of process analytical technologies (PAT), including near infrared (NIR) and Raman spectroscopy, was evaluated, to predict the amorphous content, qualitatively and quantitatively, within itraconazole-loaded formulations. Calibration models were developed using partial least squares (PLS) regression, which successfully predicted amorphous content across the range of 0–20% w/w. The models demonstrated excellent linearity (R2 = 0.998 and 0.998) and accuracy (RMSEP = 1.04% and 0.63%) for NIR and Raman spectroscopy models, respectively. Overall, this article demonstrates the feasibility of SLS 3D printing to produce solid dispersions containing a BCS II drug, and the potential for NIR and Raman spectroscopy to quantify amorphous content as a non-destructive quality control measure at the point-of-care.

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Nachtmann, Marcel, Shaun Paul Keck, Frank Braun, Hanns Simon Eckhardt, Christoph Mattolat, Norbert Gretz, Stephan Scholl, and Matthias Rädle. "A customized stand-alone photometric Raman sensor applicable in explosive atmospheres: a proof-of-concept study." Journal of Sensors and Sensor Systems 7, no. 2 (October 12, 2018): 543–49. http://dx.doi.org/10.5194/jsss-7-543-2018.

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Abstract. This paper presents an explosion-proof two-channel Raman photometer designed for chemical process monitoring in hazardous explosive atmospheres. Due to its design, alignment of components is simplified and economic in comparison to spectrometer systems. Raman spectrometers have the potential of becoming an increasingly important tool in process analysis technologies as part of molecular-specific concentration monitoring. However, in addition to the required laser power, which restricts use in potentially explosive atmospheres, the financial hurdle is also high. Within the scope of a proof of concept, it is shown that photometric measurements of Raman scattering are possible. The use of highly sensitive detectors allows the required excitation power to be reduced to levels compliant for operation in potentially explosive atmospheres. The addition of an embedded platform enables stable use as a self-sufficient sensor, since it carries out all calculations internally. Multi-pixel photon counters (MPPCs) with large detection areas of 1350 µm2 are implemented as detectors. As a result, the sensitivity of the sensor is strongly increased. This gain in sensitivity is primarily achieved through two characteristics: first, the operating principle “avalanche breakdown” to detect single photons is used; second, the size of the image projected onto the MPPC is much bigger than the pixel area in competing Raman-Spectrometers resulting in higher photon flux. This combination enables reduction of the required excitation power to levels compliant for operation in potentially explosive atmospheres. All presented experiments are performed with strongly attenuated laser power of 35 mW. These include the monitoring of the analytes ethanol and hydrogen peroxide as well as the reversible binding of CO2 to amine. Accordingly, the described embedded sensor is ideally suited as a process analytical technology (PAT) tool for applications in environments with limitations on power input.

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Gramigna, Giuseppe. "Evaluating SME Policies and Programmes—Micro-level Datasets, Analytical Toolkits and Institutional Factors." Journal of Entrepreneurship and Innovation in Emerging Economies 3, no. 2 (July 2017): 134–42. http://dx.doi.org/10.1177/2393957517721845.

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Big Data changed the paradigm of how the private sector serves its clients. The adroit use of Program Administrative Data (PAD) collected as part of the normal delivery of government services, when linked to records in other datasets, can change the cost and empirical paradigm of how the government learns what works and what does not, and can serve as the foundation for evidence-based policymaking. The linking of individual records is best achieved when records are associated with a Unique Identifier. The use of these linked datasets require a robust data-sharing and data-use infrastructure of laws and technologies that include regulations and procedures on (1) Privacy that outline which data are collected, (2) Confidentiality that outline the allowable users and uses these data, and (3) Security, that outline the excluded users and uses of these data. PAD is used for Performance Measurements to asses who was served, when they were served, how intensively they were served, and at what costs. These measurements, however, do not inform on the change in recipient behavior, or how the recipient behavior impacted a community or a region. Tracing and evaluating a program’s impacts on recipients or communities requires linking PAD to micro data found across government and possibly private entities. There are several challenges with this learning process. The most common among them is learning from insignificant, null or negative findings. Similar challenges arise when evaluating new programs that may not have been in existence long enough to gestate impacts, or for evaluating the impacts of small programs that may not have generated sufficient service-provision observations.

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Wang, Chien-Ping, Ying-Chun Shen, Peng-Chun Liou, Yu-Lun Chueh, Yue-Der Chih, Jonathan Chang, Chrong-Jung Lin, and Ya-Chin King. "Dynamic pH Sensor with Embedded Calibration Scheme by Advanced CMOS FinFET Technology." Sensors 19, no. 7 (April 2, 2019): 1585. http://dx.doi.org/10.3390/s19071585.

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In this work, we present a novel pH sensor using efficient laterally coupled structure enabled by Complementary Metal-Oxide Semiconductor (CMOS) Fin Field-Effect Transistor (FinFET) processes. This new sensor features adjustable sensitivity, wide sensing range, multi-pad sensing capability and compatibility to advanced CMOS technologies. With a self-balanced readout scheme and proposed corresponding circuit, the proposed sensor is found to be easily embedded into integrated circuits (ICs) and expanded into sensors array. To ensure the robustness of this new device, the transient response and noise analysis are performed. In addition, an embedded calibration operation scheme is implemented to prevent the proposed sensing device from the background offset from process variation, providing reliable and stable sensing results.

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Glassey, Jarka, Krist V. Gernaey, Christoph Clemens, Torsten W. Schulz, Rui Oliveira, Gerald Striedner, and Carl-Fredrik Mandenius. "Process analytical technology (PAT) for biopharmaceuticals." Biotechnology Journal 6, no. 4 (March 18, 2011): 369–77. http://dx.doi.org/10.1002/biot.201000356.

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Wright, Donald W., Jacek A. Koziel, David B. Parker, Anna Iwasinska, Thomas G. Hartman, Paula Kolvig, and Landon Wahe. "Qualitative Exploration of the ‘Rolling Unmasking Effect’ for Downwind Odor Dispersion from a Model Animal Source." International Journal of Environmental Research and Public Health 18, no. 24 (December 11, 2021): 13085. http://dx.doi.org/10.3390/ijerph182413085.

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Solving environmental odor issues can be confounded by many analytical, technological, and socioeconomic factors. Considerable know-how and technologies can fail to properly identify odorants responsible for the downwind nuisance odor and, thereby, focus on odor mitigation strategies. We propose enabling solutions to environmental odor issues utilizing troubleshooting techniques developed for the food, beverage, and consumer products industries. Our research has shown that the odorant impact-priority ranking process can be definable and relatively simple. The initial challenge is the prioritization of environmental odor character from the perspective of the impacted citizenry downwind. In this research, we utilize a natural model from the animal world to illustrate the rolling unmasking effect (RUE) and discuss it more systematically in the context of the proposed environmental odorant prioritization process. Regardless of the size and reach of an odor source, a simplification of odor character and composition typically develops with increasing dilution downwind. An extreme odor simplification-upon-dilution was demonstrated for the prehensile-tailed porcupine (P.T. porcupine); its downwind odor frontal boundary was dominated by a pair of extremely potent character-defining odorants: (1) ‘onion’/‘body odor’ and (2) ‘onion’/‘grilled’ odorants. In contrast with the outer-boundary simplicity, the near-source assessment presented considerable compositional complexity and composite odor character difference. The ultimate significance of the proposed RUE approach is the illustration of naturally occurring phenomena that explain why some environmental odors and their sources can be challenging to identify and mitigate using an analytical-only approach (focused on compound identities and concentrations). These approaches rarely move beyond comprehensive lists of volatile compounds emitted by the source. The novelty proposed herein lies in identification of those few compounds responsible for the downwind odor impacts and requiring mitigation focus.

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Rathore, A. S., R. Bhambure, and V. Ghare. "Process analytical technology (PAT) for biopharmaceutical products." Analytical and Bioanalytical Chemistry 398, no. 1 (May 18, 2010): 137–54. http://dx.doi.org/10.1007/s00216-010-3781-x.

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Kim, Eun Ji, Ji Hyeon Kim, Min-Soo Kim, Seong Hoon Jeong, and Du Hyung Choi. "Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification." Pharmaceutics 13, no. 6 (June 21, 2021): 919. http://dx.doi.org/10.3390/pharmaceutics13060919.

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Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

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Drennen, James K. "Process Analytical Technologies." NIR news 13, no. 2 (April 2002): 14. http://dx.doi.org/10.1255/nirn.659.

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Shah, Esha Bhavin, and Anuradha Gajjar. "Process Analytical Technology (PAT) in Quality Assurance: A Detailed Review." International Journal of Pharmaceutical Sciences and Nanotechnology 15, no. 1 (February 28, 2022): 5763–70. http://dx.doi.org/10.37285/ijpsn.2022.15.1.4.

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Process Analytical Technology (PAT) is a proactive initiative published by the Food and Drug Administration so as to overcome the conventional way of batch testing. As per the documented guideline it can be stated as a system for designing, analyzing, and controlling pharmaceutical manufacturing through the timely measurement of critical quality and performance parameters. PAT is a quality driven approach with innovative, strategic and rapid systems, so as to clearly understand, predict, manipulate, control and refine manufacturing processes. Owing to its multidimensional applications, process analysis can be carried out even in the most critical processes, like crystallization, by the on-line technique.PAT is one of the prime objectives stressed in the Initiative for Pharmaceutical CGMPs for the 21st Century published by the Food and Drug Administration. The chief motive of this dynamic approach is to carry out measurements on raw materials and in the in process materials or process parameters with tight controls, with a prime goal to enhance final product quality and reduce the chances of error or default/defect. The prime inventiveness of the PAT initiative is to focus on building quality inside the product and the entire manufacturing processes, in addition to continuous process improvement. The adoption of PAT approach can provide a plethora of benefits to the pharmaceutical industry by enhancing product quality while providing supercilious asset utilization and niche financial value. PAT bestows better insight of raw materials, by characterizing it physically and chemically, detailed understanding of manufacturing parameters, all of which collectively decide the fate of the quality and appeal of the final product. Unlikely to the traditional approach of testing the product at its terminal stage, PAT is a dynamic approach to keeping an eye on the manufacturing and other related processes on a continuous basis compared to a discrete one, and keeps a strict check at all stages of production. Hence this detailed review will stress on the importance of PAT and its overall conceptualization, which shall be indeed propitious for furnishing an integrated systems approach for quality design, process analyses, understanding and control, continuous improvement, knowledge and risk-based management within the FDA 21st century framework of Good manufacturing initiative and will be a useful guide to the industry and academia personnel for better understanding of this approach. Additionally it also highlights the unique synergy of Quality by Design with PAT for establishing an in depth understanding of the manufacturing process.

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Patel, Adil. "Process analytical technology – A review of game changer regulatory framework by US FDA." Journal of Community Health Management 9, no. 1 (February 15, 2022): 8–12. http://dx.doi.org/10.18231/j.jchm.2022.003.

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The concept of process analytical technology is introduced with the purpose of providing important information after the analysis of critical quality parameters which can have direct or indirect impact on the product quality. This type of information is helpful in maintaining the product quality while keeping the manufacturing cost low. The implementation of PAT will potentially improve the operational control and compliance as per regulatory guidelines for continuous real time quality assurance during manufacturing. The concept is relatively new for both academia and industry hence Considerable amount of study has been carried out to explore the various aspects of PAT guidelines and their successful implementation. This review mainly contains introduction and background of PAT guidelines as the first step in QBD implementation. Detailed understanding of analysis and selection of suitable analytical technique is the most important aspect of PAT guidelines. These analytical techniques will even play crucial role at the time of scale up and detailed evaluation of drug and dosage forms. The main purpose of this review is to understand the right perspective of PAT guidelines towards the goal of achieving products with highest quality.

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Helgers, Heribert, Axel Schmidt, Lara Julia Lohmann, Florian Lukas Vetter, Alex Juckers, Christoph Jensch, Mourad Mouellef, Steffen Zobel-Roos, and Jochen Strube. "Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing." Processes 9, no. 1 (January 18, 2021): 172. http://dx.doi.org/10.3390/pr9010172.

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Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations in batch or fed-batch operations. A more sophisticated process control strategy is needed to adjust operation parameters and keep product quality constant during long-term operations. In the present study, the applicability of a combination of spectroscopic methods was evaluated to enable Advanced Process Control (APC) in continuous manufacturing by Process Analytical Technology (PAT). In upstream processing (USP) and aqueous two-phase extraction (ATPE), Raman-, Fourier-transformed infrared (FTIR), fluorescence- and ultraviolet/visible- (UV/Vis) spectroscopy have been successfully applied for titer and purity prediction. Raman spectroscopy was the most versatile and robust method in USP, ATPE, and precipitation and is therefore recommended as primary PAT. In later process stages, the combination of UV/Vis and fluorescence spectroscopy was able to overcome difficulties in titer and purity prediction induced by overlapping side component spectra. Based on the developed spectroscopic predictions, dynamic control of unit operations was demonstrated in sophisticated simulation studies. A PAT development workflow for holistic process development was proposed.

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Tihonova, V. V., and A. S. Saushkina. "Application of Raman spectroscopy to process analytical technology (PAT)." Problems of Biological Medical and Pharmaceutical Chemistry 23, no. 10 (2020): 35–39. http://dx.doi.org/10.29296/25877313-2020-10-05.

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Broger, Tobias, Res P. Odermatt, Pablo Ledergerber, and Bernhard Sonnleitner. "Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)." CHIMIA International Journal for Chemistry 63, no. 3 (March 25, 2009): 171–73. http://dx.doi.org/10.2533/chimia.2009.171.

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Lopes, João A., Teresa P. Alves, and José C. Menezes. "CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING." IFAC Proceedings Volumes 38, no. 1 (2005): 153–58. http://dx.doi.org/10.3182/20050703-6-cz-1902.02229.

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Lopes, João A., Paula F. Costa, Teresa P. Alves, and José C. Menezes. "Chemometrics in bioprocess engineering: process analytical technology (PAT) applications." Chemometrics and Intelligent Laboratory Systems 74, no. 2 (December 2004): 269–75. http://dx.doi.org/10.1016/j.chemolab.2004.07.006.

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Rathore, Anurag S., Krist V. Gernaey, Cecília R. C. Calado, and Seongkyu Yoon. "Process Analytical Technologies in Biopharmaceutical Process Development." Journal of Chemical Technology & Biotechnology 90, no. 2 (January 12, 2015): 213–14. http://dx.doi.org/10.1002/jctb.4614.

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Malwade, Chandrakant R., and Haiyan Qu. "Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients." Current Pharmaceutical Design 24, no. 21 (October 15, 2018): 2456–72. http://dx.doi.org/10.2174/1381612824666180629111632.

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Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities. Crystallization with its ability to engineer the final product to the desired qualities such as purity, polymorphic form, particle size and shape is one of the most important steps involved in the manufacturing of APIs. Therefore, development of crystallization processes with better understanding of process parameters and their impact on quality of APIs and subsequently the drug products assume great significance for the pharmaceutical industry. Methods: This review paper focuses on the application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design of crystallization processes in the manufacturing of APIs. Results: Firstly, various steps involved in the drug development process are introduced briefly with emphasis on crystallization as one of the most important steps in manufacturing of drug products. Secondly, Critical Quality Attributes (CQAs) of drug products, their dependence on material attributes of APIs and role of crystallization in manipulating material attributes of APIs has been discussed. Finally, application of PAT tools such as advanced process analyzers for continuous monitoring, chemometric methods for multivariate data analysis, and control strategy for APIs crystallization processes has been reviewed along with some examples. Conclusion: Application of PAT in crystallization of APIs facilitates development of robust processes that works within the design space to produce the drug products of consistent quality. Furthermore, it opens up the opportunities for continuous improvement of the process by generating knowledge base of existing processes.

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Misra, N. N., Carl Sullivan, and P. J. Cullen. "Process Analytical Technology (PAT) and Multivariate Methods for Downstream Processes." Current Biochemical Engineering 2, no. 1 (April 13, 2015): 4–16. http://dx.doi.org/10.2174/2213385203666150219231836.

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Spichiger, David, and Tobias Merz. "Symposium on Process Analytical Technology (PAT) at ILMAC Lausanne 2018." CHIMIA International Journal for Chemistry 72, no. 11 (November 30, 2018): 824–25. http://dx.doi.org/10.2533/chimia.2018.824.

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Juckers, Alex, Petra Knerr, Frank Harms, and Jochen Strube. "Advanced Process Analytical Technology in Combination with Process Modeling for Endpoint and Model Parameter Determination in Lyophilization Process Design and Optimization." Processes 9, no. 9 (September 7, 2021): 1600. http://dx.doi.org/10.3390/pr9091600.

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Lyophilization is widely used in the preservation of thermolabile products. The main shortcoming is the long processing time. Lyophilization processes are mostly based on a recipe that is not changed, but, with the Quality by Design (QbD) approach and use of Process Analytical Technology (PAT), the process duration can be optimized for maximum productivity while ensuring product safety. In this work, an advanced PAT approach is used for the endpoint determination of primary drying. Manometric temperature measurement (MTM) and comparative pressure measurement are used to determine the endpoint of the batch while a modeling approach is outlined that is able to calculate the endpoint of every vial in the batch. This approach can be used for process development, control and optimization.

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Chandramohan, Laakshmana Sabari, Suryanarayana Doolla, and S. A. Khaparde. "Implementing PAT with Standards." International Journal of Emerging Electric Power Systems 17, no. 1 (February 1, 2016): 49–58. http://dx.doi.org/10.1515/ijeeps-2015-0117.

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Abstract Perform Achieve Trade (PAT) is a market-based incentive mechanism to promote energy efficiency. The purpose of this work is to address the challenges inherent to inconsistent representation of business processes, and interoperability issues in PAT like cap-and-trade mechanisms especially when scaled. Studies by various agencies have highlighted that as the mechanism evolves including more industrial sectors and industries in its ambit, implementation will become more challenging. This paper analyses the major needs of PAT (namely tracking, monitoring, auditing & verifying energy-saving reports, and providing technical support & guidance to stakeholders); and how the aforesaid reasons affect them. Though current technologies can handle these challenges to an extent, standardization activities for implementation have been scanty for PAT and this work attempts to evolve them. The inconsistent modification of business processes, rules, and procedures across stakeholders, and interoperability among heterogeneous systems are addressed. This paper proposes the adoption of specifically two standards into PAT, namely Business Process Model and Notation for maintaining consistency in business process modelling, and Common Information Model (IEC 61970, 61968, 62325 combined) for information exchange. Detailed architecture and organization of these adoptions are reported. The work can be used by PAT implementing agencies, stakeholders, and standardization bodies.

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Hu, Yong. "Wear Characteristics of Padded Air Bearing Sliders During a Contact Take-Off Process." Journal of Tribology 122, no. 3 (June 30, 1999): 628–32. http://dx.doi.org/10.1115/1.555412.

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The pressing and challenging demand for resolving the stiction/glide-height conflict, driven by today’s ever decreasing head/disk spacing, forces us to constantly search for new technologies. One of them is padding the slider’s air bearing surface. Although the padded air bearing sliders can significantly reduce the stiction, the wear of these landing pads becomes a central issue. This paper attempts to analytically predict the wear characteristics of the landing pads during a contact take-off process. A wear factor derived from the adhesive wear law is employed to measure the wear extent of the landing pads. The contact force profile and wear factor of each pad are calculated through the partial contact air bearing simulation of a slider’s take-off process. It is found that the rear pad wears an order magnitude more than the leading pads. The wear volume of the rear pad increases exponentially with pad height, interface roughness and altitude. Raising the leading pads alone slightly reduces the wear of the rear pad. Placing the rear pad away from the slider’s trailing edge, however, substantially alleviates the wear of the rear pad. Finally, a lightly textured pad/disk interface decreases the pads’ wear to a minimum value for a given padded air bearing design. [S0742-4787(00)01903-2]

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Cayme, Jan-Michael. "Analytical Chemistry Methods of Estimating the Hydraulic Lime Characteristics of Mortars from a Spanish Colonial Period Fortification in the Philippines: Perspective of a Southeast Asian Country | Mga Pamamaraan ng Suriing Kapnayan sa Pagtantya ng Katangiang Haydroliko ng Apog sa Argamasa na Mula sa Isang Panahon ng Kastilang Kuta sa Pilipinas: Pananaw ng Isang Bansa sa Timog-Silangang Asya." SPAFA Journal 6 (March 29, 2022): 5fabjq9471. http://dx.doi.org/10.26721/spafajournal.5fabjq9471.

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This study has provided an analytical chemistry method to reveal the production technologies employed in lime mortar making from a Spanish Colonial Period fortification in Bacolod, Lanao del Norte, Philippines. Analytical techniques such as Energy Dispersive X-ray Fluorescence (EDXRF) and Thermogravimetric analysis (TGA) effectively provided general information on the chemical composition of the lime mortars and the hydraulic nature of the binder used. Mortar samples from different areas in the fort, were found to be made from a calcitic lime source possibly of marine shell origin. The hydraulic characteristic of both mortars is due to clay additives suggesting that local knowledge of this process is known during that period. The EDXRF and TGA techniques applied to the samples in this study will address the lack of systematic and detailed baseline chemical data on historical lime mortars in the Philippines and other Southeast Asian countries, which is vital for future conservation work in the ASEAN region. Ang pag-aaral na ito ay nagbigay ng isang maupanuring-kimika na pamamaraan upang maipakita ang mga teknolohiya ng paggawa sa argamasa na apog mula sa isang kuta na itinayo noong panahon ng mga Kastila sa Bacolod, Lanao del Norte, Pilipinas. Ang mga ginamit na instrument sa pananaliksik tulad ng Energy Dispersive X-ray Fluorescence (EDXRF) at Thermogravimetric analysis (TGA) ay mabisang nagbigay ng pangkalahatang impormasyon tungkol sa kemikal na komposisyon ng mga apog na argamasa at haydrolikong likas na ginamit. Ang mga argamasa na ginamit sa pagaaral na ito, na nagmula sa iba`t ibang mga parte ng kuta, ay natagpuan na ginawa mula sa isang calcitic na pinagmulan na maaring galing sa mga kabibe sa dagat. Ang haydrolikong katangian ng parehong argamasa ay dahil sa mga ihinalong luad na nagmumungkahi na ang lokal na kaalaman sa prosesong ito ay alam na ng mga gumawa nuong panahong iyon. Ang EDXRF at TGA na ginamit sa pagaaral na ito ay tutugon sa kakulangan ng sistematiko at detalyadong kemikal na datos sa mga makasaysayang apog na argamasa sa Pilipinas at iba pang mga bansa sa Timog-Silangang Asya, na mahalaga para sa gawaing kinabukasan ng konserbasyon sa rehiyon ng ASEAN.

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Pohle, K., and M. Sandmann. "Applied fiber‐optical sensing in photobioreactors as process analytical technology (PAT)." Chemie Ingenieur Technik 94, no. 9 (August 25, 2022): 1272–73. http://dx.doi.org/10.1002/cite.202255029.

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38

Juckers, A., P. Knerr, F. Harms, and J. Strube. "Emerging process analytical technology (PAT) for characterization of freeze‐drying processes." Chemie Ingenieur Technik 94, no. 9 (August 25, 2022): 1287. http://dx.doi.org/10.1002/cite.202255089.

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39

Kaiser, C., T. Peuker, T. Bauch, A. Ellert, and R. Luttmann. "PAT – PROCESS ANALYTICAL TECHNOLOGY IN CULTIVATION PROCESSES WITH RECOMBINANT ESCHERICHIA COLI." IFAC Proceedings Volumes 40, no. 4 (2007): 267–72. http://dx.doi.org/10.3182/20070604-3-mx-2914.00046.

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40

Munson, James, C. Freeman Stanfield, and Bir Gujral. "A Review of Process Analytical Technology (PAT) in the U.S.Pharmaceutical Industry." Current Pharmaceutical Analysis 2, no. 4 (November 1, 2006): 405–14. http://dx.doi.org/10.2174/157341206778699582.

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Simon, Levente L., Hajnalka Pataki, György Marosi, Fabian Meemken, Konrad Hungerbühler, Alfons Baiker, Srinivas Tummala, et al. "Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review." Organic Process Research & Development 19, no. 1 (January 8, 2015): 3–62. http://dx.doi.org/10.1021/op500261y.

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42

Joksch, M., B. Kavsek, and J. Scheiblauer. "Process Analytical Technology (PAT) und Prozesskontrolle am Beispiel einer Hefe-Fermentation." Chemie Ingenieur Technik 86, no. 9 (August 28, 2014): 1574. http://dx.doi.org/10.1002/cite.201450301.

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43

Esmonde-White, Karen A., Maryann Cuellar, and Ian R. Lewis. "The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing." Analytical and Bioanalytical Chemistry 414, no. 2 (October 20, 2021): 969–91. http://dx.doi.org/10.1007/s00216-021-03727-4.

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AbstractBiopharmaceuticals have revolutionized the field of medicine in the types of active ingredient molecules and treatable indications. Adoption of Quality by Design and Process Analytical Technology (PAT) frameworks has helped the biopharmaceutical field to realize consistent product quality, process intensification, and real-time control. As part of the PAT strategy, Raman spectroscopy offers many benefits and is used successfully in bioprocessing from single-cell analysis to cGMP process control. Since first introduced in 2011 for industrial bioprocessing applications, Raman has become a first-choice PAT for monitoring and controlling upstream bioprocesses because it facilitates advanced process control and enables consistent process quality. This paper will discuss new frontiers in extending these successes in upstream from scale-down to commercial manufacturing. New reports concerning the use of Raman spectroscopy in the basic science of single cells and downstream process monitoring illustrate industrial recognition of Raman’s value throughout a biopharmaceutical product’s lifecycle. Finally, we draw upon a nearly 90-year history in biological Raman spectroscopy to provide the basis for laboratory and in-line measurements of protein quality, including higher-order structure and composition modifications, to support formulation development. Graphical abstract

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44

Raman, N. V. V. S. S., Useni Reddy Mallu, and Hanimi Reddy Bapatu. "Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing." Journal of Chemistry 2015 (2015): 1–8. http://dx.doi.org/10.1155/2015/435129.

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Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspective. As of now there is no specific requirements for AQbD (Analytical Quality by Design) and PAT in analytical development from all regulatory agencies. In this review, authors have discussed the implementation of QbD and AQbD simultaneously for API synthetic process and analytical methods development. AQbD key tools are identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM). Simultaneous implementation of QbD activities in synthetic and analytical development will provide the highest quality product by minimizing the risks and even it is very good input for PAT approach.

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Grassi, Silvia, Lorenzo Strani, Cristina Alamprese, Nicolò Pricca, Ernestina Casiraghi, and Giovanni Cabassi. "A FT-NIR Process Analytical Technology Approach for Milk Renneting Control." Foods 11, no. 1 (December 23, 2021): 33. http://dx.doi.org/10.3390/foods11010033.

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The study proposes a process analytical technology (PAT) approach for the control of milk coagulation through near infrared spectroscopy (NIRS), computing multivariate statistical process control (MSPC) charts, based on principal component analysis (PCA). Reconstituted skimmed milk and commercial pasteurized skimmed milk were mixed at two different ratios (60:40 and 40:60). Each mix ratio was prepared in six replicates and used for coagulation trials, monitored by fundamental rheology, as a reference method, and NIRS by inserting a probe directly in the coagulation vat and collecting spectra at two different acquisition times, i.e., 60 s or 10 s. Furthermore, three failure coagulation trials were performed, deliberately changing temperature or rennet and CaCl2 concentration. The comparison with fundamental rheology results confirmed the effectiveness of NIRS to monitor milk renneting. The reduced spectral acquisition time (10 s) showed data highly correlated (r > 0.99) to those acquired with longer acquisition time. The developed decision trees, based on PC1 scores and T2 MSPC charts, confirmed the suitability of the proposed approach for the prediction of coagulation times and for the detection of possible failures. In conclusion, the work provides a robust but simple PAT approach to assist cheesemakers in monitoring the coagulation step in real-time.

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Hussain, A., and T. Hale. "Solicitation of Papers: AAPS PharmSciTech Theme Issue on Process Analytical Technology (PAT)." AAPS PharmSciTech 05, no. 01 (2004): e2. http://dx.doi.org/10.1208/pt050102.

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Read, E. K., J. T. Park, R. B. Shah, B. S. Riley, K. A. Brorson, and A. S. Rathore. "Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications." Biotechnology and Bioengineering 105, no. 2 (February 1, 2010): 276–84. http://dx.doi.org/10.1002/bit.22528.

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Read, E. K., R. B. Shah, B. S. Riley, J. T. Park, K. A. Brorson, and A. S. Rathore. "Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications." Biotechnology and Bioengineering 105, no. 2 (February 1, 2010): 285–95. http://dx.doi.org/10.1002/bit.22529.

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Kaiser, C., T. Pototzki, A. Ellert, and R. Luttmann. "Applications of PAT-Process Analytical Technology in Recombinant Protein Processes withEscherichia coli." Engineering in Life Sciences 8, no. 2 (April 2008): 132–38. http://dx.doi.org/10.1002/elsc.200720232.

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Streefland, Mathieu, Dirk E. Martens, E. Coen Beuvery, and René H. Wijffels. "Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production." Engineering in Life Sciences 13, no. 3 (April 27, 2013): 212–23. http://dx.doi.org/10.1002/elsc.201200025.

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Journal articles on the topic 'Process analytical technologies (PAT)'

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