Bibliographies thématiques / Continuous pharmaceutical manufacturing

Littérature scientifique sur le sujet « Continuous pharmaceutical manufacturing »

Auteur : Grafiati

Publié le 14 mars 2023

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Articles de revues sur le sujet "Continuous pharmaceutical manufacturing"

Korhonen, Ossi. « Continuous Pharmaceutical Manufacturing ». Pharmaceutics 12, n^o 10 (23 septembre 2020) : 910. http://dx.doi.org/10.3390/pharmaceutics12100910.

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Burcham, Christopher L., Alastair J. Florence et Martin D. Johnson. « Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing ». Annual Review of Chemical and Biomolecular Engineering 9, n^o 1 (7 juin 2018) : 253–81. http://dx.doi.org/10.1146/annurev-chembioeng-060817-084355.

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The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

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Hock, Sia Chong, Teh Kee Siang et Chan Lai Wah. « Continuous manufacturing versus batch manufacturing : benefits, opportunities and challenges for manufacturers and regulators ». Generics and Biosimilars Initiative Journal 10, n^o 1 (15 mars 2021) : 44–56. http://dx.doi.org/10.5639/gabij.2021.1001.004.

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Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals has transformed from buzzword to reality, with at least eight currently approved drugs produced by CM. Propelled by various driving forces, manufacturers and regulators have recognized the benefits of CM and are awaiting the completion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13, a harmonized guideline on CM that would be implemented by ICH members. Although significant progress is evident, the uptake of CM is still sluggish in the pharmaceutical industry due to many existing challenges that have hindered manufacturers from adopting this technology. The top two barriers that manufacturers currently face are regulatory uncertainties and high initial cost. These issues are crucial in unleashing the untapped potential of CM, which has significant implications on patients’ access to life-saving medicines, while mutually benefitting manufacturers and regulators. Despite numerous studies, there have been few existing publications that review current regulatory guidelines, highlight the latest challenges extensively and propose recommendations that are applicable for all pharmaceuticals and biopharmaceuticals. Therefore, this critical review aims to present the recent progress and existing challenges to provide greater clarity for manufacturers on CM. This review also proposes vital recommendations and future perspectives. These include regulatory harmonization, managing financial risks, hybrid processes, capacity building, a culture of quality and Pharma 4.0. While regulators and the industry work towards creating a harmonized guideline on CM, manufacturers should focus on overcoming existing cost, technical and cultural challenges to facilitate the implementation of CM.

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TAHARA, Kohei. « Spherical Crystallization for Pharmaceutical Continuous Manufacturing System ». Hosokawa Powder Technology Foundation ANNUAL REPORT 25 (2017) : 75–78. http://dx.doi.org/10.14356/hptf.15111.

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May, Scott A. « Flow chemistry, continuous processing, and continuous manufacturing : A pharmaceutical perspective ». Journal of Flow Chemistry 7, n^o 3–4 (septembre 2017) : 137–45. http://dx.doi.org/10.1556/1846.2017.00029.

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Desai, Parind Mahendrakumar, Griet Van Vaerenbergh, Jim Holman, Celine Valeria Liew et Paul Wan Sia Heng. « Continuous manufacturing : the future in pharmaceutical solid dosage form manufacturing ». Pharmaceutical Bioprocessing 3, n^o 5 (septembre 2015) : 357–60. http://dx.doi.org/10.4155/pbp.15.19.

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Myerson, Allan S., Markus Krumme, Moheb Nasr, Hayden Thomas et Richard D. Braatz. « Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium ». Journal of Pharmaceutical Sciences 104, n^o 3 (mars 2015) : 832–39. http://dx.doi.org/10.1002/jps.24311.

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Wahlich, John. « Review : Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms ». Pharmaceutics 13, n^o 8 (22 août 2021) : 1311. http://dx.doi.org/10.3390/pharmaceutics13081311.

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Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.

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Lee, Sau L., Thomas F. O’Connor, Xiaochuan Yang, Celia N. Cruz, Sharmista Chatterjee, Rapti D. Madurawe, Christine M. V. Moore, Lawrence X. Yu et Janet Woodcock. « Modernizing Pharmaceutical Manufacturing : from Batch to Continuous Production ». Journal of Pharmaceutical Innovation 10, n^o 3 (19 mars 2015) : 191–99. http://dx.doi.org/10.1007/s12247-015-9215-8.

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Rehrl, Jakob, Julia Kruisz, Stephan Sacher, Johannes Khinast et Martin Horn. « Optimized continuous pharmaceutical manufacturing via model-predictive control ». International Journal of Pharmaceutics 510, n^o 1 (août 2016) : 100–115. http://dx.doi.org/10.1016/j.ijpharm.2016.06.024.

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Thèses sur le sujet "Continuous pharmaceutical manufacturing"

Abel, Matthew J. « Process systems engineering of continuous pharmaceutical manufacturing ». Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/58446.

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Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering, February 2010.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 290-299).
Continuous manufacturing offers a number of operational and financial benefits to pharmaceutical companies. This research examines the critical blending step for continuous pharmaceutical manufacturing and the characteristics of continuous downstream pharmaceutical manufacturing systems. Discrete element method (DEM) simulations were used to develop novel insights into the mechanism of mixing for continuous blending of cohesive pharmaceutical powders and to examine the effects of particle properties, blender design and operating conditions on blend homogeneity. To place continuous blending into the context of pharmaceutical manufacturing, the scope of the analysis was expanded to process system models of continuous downstream pharmaceutical manufacturing. DEM simulations were used to study the mechanisms of mixing in the continuous blending of pharmaceutical powders. Diffusive mixing from the avalanching particles appears to be the dominant mechanism of mixing in both the axial and radial direction for the double helical ribbon blender. This result can guide the development of future continuous pharmaceutical powder blenders by optimizing the mixing elements to increase the amount of particles transported to a position where they can avalanche/flow and diffusively mix. A range of particle properties, blender designs and operating conditions were examined for their effects on flow behavior and blend homogeneity. Three particle properties were examined: particle size, polydispersity and cohesive force.
(cont.) Particle size was observed to be positively correlated to both flow rates and blend homogeneity. Polydispersity had no effect on flow rate and was negatively correlated to homogeneity. Cohesive force was negatively correlated to flow rate and had little to no effect on homogeneity. Two modifications of blender design were analyzed: changes in blender size and changes in shaft design. Blender size was observed to be positively correlated to flow rate and negatively correlated to homogeneity. The paddle shaft designs created a more homogeneous powder blend than the double helical ribbon shaft. Two operating parameters were also studied: rotation rate and fill fraction. Rotation rate was positively correlated to both flow rate and homogeneity. Fill fraction had the interesting result of being positively correlated to the absolute flow rate, but negatively correlated to the fill mass normalized flow rate. In addition, fill fraction has a clear negative correlation to homogeneity above fill fractions of 0.55, but is inconsistent for fill fractions lower than this. This research on particle properties, blender designs and operating conditions will help to guide the operation of continuous pharmaceutical blenders and the design of continuous pharmaceutical manufacturing systems. Process simulations comparing model batch and continuous downstream pharmaceutical manufacturing systems have quantified some of the potential size, cost and performance benefits of continuous processes. The models showed significant reductions in process equipment sizes for continuous manufacturing particularly in the blending step.
(cont.) This reduction in equipment size translates to capital cost (CAPEX) savings for both the continuous process equipment and manufacturing facilities. The steady state operation of continuous processing also reduces the labor requirements and gives the continuous processes an operating cost (OPEX) advantage over batch processes. This research has contributed to the understanding of continuous pharmaceutical powder blending and quantified some of the benefits of continuous downstream pharmaceutical manufacturing. This work is being continued by the Novartis-MIT Center for Continuous Manufacturing whose work is providing the foundation for future industrial scale pharmaceutical continuous manufacturing systems.
by Matthew J. Abel.
Ph.D.

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Bell, Erin R. « Melt extrusion and continuous manufacturing of pharmaceutical materials ». Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/65755.

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Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering, 2011.
Cataloged from PDF version of thesis.
Includes bibliographical references.
Melt extrusion is an alternative processing technique that operates continuously, reduces the total number of unit operations, allows for incorporation of difficult-to-process drug substances, and has the potential to achieve tablets of better quality and consistency compared to traditional methods. Thus, our goal was to evaluate melt extrusion as a viable processing alternative and expand our scientific knowledge such that we gain predictive capabilities of tablet characteristics, i.e., quality by design. This new knowledge will aid future process design thereby helping to reduce time and costs associated with pharmaceutical solid dosage form production. The residence time distribution for melt extrusion has been characterized using a single parameter model. When combined with assumed first-order reaction rate kinetics and an Arrhenius reaction rate constant, the model can accurately predict the amount of drug product lost to temperature driven degradation. The model prediction agreed well with experimentally determined fractional conversion. The physical stability of amorphous Molecule A was characterized using enthalpy of relaxation measurements. Molecular level rearrangements are the source of physical instability for the fragile glass forming Molecule A. The instability can be modified by introducing a second component, which contributes to the overall enthalpy change. Coating amorphous Molecule A tablets with a polyvinyl alcohol based coating material reduces moisture uptake during storage. The coating material preferentially uptakes water from the atmosphere, restricting moisture from entering the tablet core and causing premature dissolution or degradation. The dissolution behavior of Molecule A tablets can be tailored with the addition of water soluble materials. Dissolution rate constants for Molecule A tablets have been calculated for different formulations and can be used as a resource when designing new solid dosage forms with desired dissolution characteristics. A novel 100% Molecule A melt extrusion process has been created, reducing the number of overall unit operations and eliminating troublesome blending inconsistencies. An additional formulation that maintains the crystallinity of Molecule A by processing with polyethylene glycol below Molecule A's melting temperature is physically and chemically stable and ready for implementation in a continuous production line. The mixing achieved within the extruder for this formulation is sufficient to eliminate a pre-mixing unit operation.
by Erin R. Bell.
Ph.D.

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Tan, Li Ph D. Massachusetts Institute of Technology. « Heterogeneous nucleation of active pharmaceutical ingredients on polymers : applications in continuous pharmaceutical manufacturing ». Thesis, Massachusetts Institute of Technology, 2015. http://hdl.handle.net/1721.1/101511.

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Thesis: Ph. D., Massachusetts Institute of Technology, Department of Chemical Engineering, 2015.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 92-105).
In this thesis work, we aimed to explore crystallization processes for small molecule API compounds based on engineered polymer surfaces that could be used in continuous manufacturing. First, we identified a library of polymers that can be used and selected PVA as the model polymer based on its solution and film properties. We also illustrated a rational approach for designing and fabricating PVA film surfaces for increasing heterogeneous nucleation rate of different compounds and enable polymorph selection. The design philosophy was to select prevalent angles between major faces of crystals according to a selection of compounds, and to create substrate surfaces with indentations that include these angles. Nucleation induction time trends showed that heterogeneous nucleation rates were accelerated by at least an order of magnitude in the presence of PVA due to the favorable interactions between the model compounds and the polymer. Nucleation rates were further increased for patterned substrates with matching geometries. Surface indentations with non-matching angles resulted in faster nucleation rates than flat films but slower than matching geometries because they only increased the effective area of the films and their roughness. X-ray diffraction was used to reveal faces that preferentially interacted with the PVA side chains and to deduce possible arrangement of solute molecules at the corners of the indentations. Combining X-ray data and morphology of the crystal product, we suggest that matching geometries on the substrate enhanced nucleation of compounds. In addition to enhancing nucleation rate, polymorph selection was possible in the presence of the polymer substrate to yield a higher percentage of thermodynamically stable gamma indomethacin. Offline Raman experiments and in-line morphology determination confirmed that polymorph control of the final crystal product via kinetic control of the nucleation process was viable. For the aspirin system, the 85 degree angle lead to the highest rate of nucleation; for the polymorphic indomethacin system, XRPD results showed that gamma form preferentially formed on the PVA films with 65 and 80 degree angles leading to the largest reduction in nucleation induction time. Kinetic Monte Carlo simulation showed that a crystallizer incorporating both nucleation and crystal growth in the absence of active mass transfer would have too small a throughput and too large a footprint to be useful. The main reasons were long average nucleation induction times and slow crystal growth in the absence of convection. A set of batch desupersaturation experiments showed that mass transfer limited growth dominate the crystal growth kinetics at low supersaturations when nucleation events were suppressed. An increase in the bulk fluid velocity increased the effective growth kinetics in the system when mass transfer kinetics dominated. Steady state modeling based on the first principle approach was performed using a combination of Navier Stokes Equations and diffusion-convection mass transport equations. The modeling result demonstrated that for mass transfer from a moving fluid to a stationary surface, a thin momentum and concentration boundary layer existed at the leading edge, which resulted in much higher local mass transfer rates. In the absence of momentum boundary layers, mass transfer could only occur via diffusion, which resulted in slow growth kinetics. The first principle model was used to derive dimensionless number correlations for the continuous crystallizer.
by Li Tan.
Ph. D.

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Barcena, Jose R. (Jose Roberto). « Materials properties of pharmaceutical formulations for thin-film-tablet continuous manufacturing ». Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76120.

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Thesis (S.B.)--Massachusetts Institute of Technology, Dept. of Materials Science and Engineering, 2012.
Page 43 blank. Cataloged from PDF version of thesis.
Includes bibliographical references (p. 41-42).
The development of manufacturing tablets in a continuous way has been possible greatly to the fabrication of polymer based thin-films. It is estimated that the pharmaceutical industry loses as much as a 25% on revenues based on the currently employed batch manufacturing method. Here we studied a continuous way of manufacturing tablets based on API/based polymer formulations that are cast and subsequently rolled into a tablet. Selections of two active pharmaceutical ingredients (SPP-100 and Acetaminophen) were studied into how well it forms mechanical robust, chemical and physical compatible HPMC polymer based films. As well, HPMC polymer based films with no drug loading were compared to measure out the dispersion of the drug on the film. Physiochemical studies were performed by DSC, XRD, FT-IR, and SEM. Moisture content was measured out by Karl Fischer Titration and mechanical properties such as tensile strength were measured for all API/HPMC and placebo films. It was found that the mechanical and physiochemical properties of SPP-100/HPMC films were regarded as the most promising thin film tablet candidate and it is further being tested for other mechanical properties such as bonding, friction, and compression.
by Jose R. Barcena.
S.B.

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Slaughter, Ryan (Ryan R. ). « The development of a thin-film rollforming process for pharmaceutical continuous manufacturing ». Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/81136.

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Thesis (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 51-53).
In this thesis, a continuous rollforming process for the folding of thin-films was proposed and studied as a key step in the continuous manufacturing of pharmaceutical tablets. HPMC and PEG based polymeric thin-films were considered for this application. An experimental apparatus was designed and developed to test the folding of thin-films. The experimental apparatus was designed in a modular fashion to facilitate testing of various process parameters. Analysis was carried out for the folding operations, based on which two folding strategies were proposed - (i) without scoring and (ii) with scoring. The first strategy relies on elastic deformation of the thin-films, whereas the later depends on localized, plastic deformation caused by the scoring geometry. From the experiments on folding we identified three regimes of process operation namely: insufficient scoring, appropriate scoring, and excessive scoring. The implications of different levels of scoring were observed and understood carefully for the scoring and folding operation. Practical guidelines were developed for carrying out folding successfully and the scope of future work was discussed.
by Ryan Slaughter.
S.M.

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Foguth, Lucas Charles. « Integration of quality-by-design into control systems design for continuous pharmaceutical manufacturing ». Thesis, Massachusetts Institute of Technology, 2016. http://hdl.handle.net/1721.1/104204.

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Thesis: Ph. D., Massachusetts Institute of Technology, Department of Chemical Engineering, 2016.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 121-126).
In the pharmaceutical industry there has recently been much interest in design spaces: sets of critical process parameters (CPPs) which guarantee that critical quality attributes (CQAs) of a manufacturing process are within specifications. For continuous pharmaceutical processes, design spaces are usually calculated by assuming steady state operation and approximating the mapping between CPPs and CQAs using a Taylor series. The full design space can then be calculated using a plantwide approach or a unit-by-unit approach. Common inner approximations of the design space (e.g. hyper-rectangles) can result in significant conservatism, especially when a unit-by-unit approach is employed. Because control loops tend to have a linearizing effect on processes, design spaces for closed-loop processes can often be calculated using low-order Taylor series approximations, resulting in simpler expressions for the full design space (e.g. polytopes). Control loops also tend to enlarge design spaces, sometimes by more than an order of magnitude. Unfortunately, disturbances, noise, and uncertainties will prevent real processes from ever reaching "steady state". Therefore, design spaces calculated at steady state cannot be used to guarantee quality specifications. In fact, because design spaces fail to take into account any process dynamics, constraining a controller to work within a design space may result in failure to meet quality specifications, significant degradation of controller performance, and input jitter. As a substitute for design space, robust model predictive control (RMPC) is a promising technology for dynamically guaranteeing constraint satisfaction on process outputs. Although many RMPC algorithms have been proposed in the literature, the computational cost of these algorithms tends to be a strong function of the state vector size. This is problematic for continuous pharmaceutical processes, which are typically high- or infinite-dimensional. However, input-output models (e.g. finite step response models) can integrated with traditional RMPC strategies to robustly control high-dimensional systems. Although RMPC can be used to counteract the presence of disturbances, uncertainty, and measurement noise, faults also present a threat to quality constraint satisfaction of continuous pharmaceutical processes. Active fault diagnosis of hybrid systems is particularly difficult due to the explosion of mode combinations with prediction horizon. Fortunately, the set of input sequences which do not guarantee diagnosis can be outer bounded offline as a function of a parameterized initial condition set. This enables an algorithm for guaranteed active fault diagnosis of hybrid systems which can be implemented quickly online.
by Lucas Charles Foguth.
Ph. D.

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Pauli, Victoria [Verfasser]. « Development and Implementation of a Redundant Process Control Strategy in Pharmaceutical Continuous Manufacturing / Victoria Pauli ». Düsseldorf : Universitäts- und Landesbibliothek der Heinrich-Heine-Universität Düsseldorf, 2019. http://d-nb.info/1195213417/34.

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Collins, Donovan (Donovan Scott). « Feature-based investment cost estimation based on modular design of a continuous pharmaceutical manufacturing system ». Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/66063.

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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Global Operations Program at MIT, June 2011.
"June 2011." Cataloged from PDF version of thesis.
Includes bibliographical references (p. 72-73).
Previous studies of continuous manufacturing processes have used equipment-factored cost estimation methods to predict savings in initial plant investment costs. In order to challenge and validate the existing methods of cost estimation, feature-based cost estimates were constructed based on a modular process design model. Synthesis of an existing chemical intermediate was selected as the model continuous process. A continuous process was designed that was a literal, step by step, translation of the batch process. Supporting design work included process flow diagrams and basic piping and instrumentation diagrams. Design parameters from the process model were combined with feature-based costs to develop a series of segmented cost estimates for the model continuous plant at several production scales. Based on this analysis, the continuous facility seems to be intrinsically less expensive only at a relatively high production scale. Additionally, the distribution of cost areas for the continuous facility differs significantly from the distribution previous assumed for batch plants. This finding suggests that current models may not be appropriate for generating cost estimates for continuous plants. These results should not have a significant negative impact on the value proposition for the continuous manufacturing platform. The continuous process designed for this project was not optimized. Therefore, this work reiterates that the switch to continuous must be accompanied with optimization and innovation in the underlying continuous chemistry.
by Donovan Collins.
S.M.
M.B.A.

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Holman, James William. « Assessing the use of twin screw wet granulation in a multi stage manufacturing process for the continuous production of pharmaceutical products ». Thesis, University of Surrey, 2013. http://epubs.surrey.ac.uk/807047/.

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Traditionally pharmaceutical manufacture is conducted on a batch basis but significant resources are being invested into the use of intensified continuous processes. This dissertation evaluates the use of a combined twin screw and segmented fluid bed drying process to produce granules on a continuous basis. The experimental program was conducted using structured Design of Experiments in three stages. • Wet granulation only: Investigated the initial relationships between liquid/solid ratio and power required for wet granulation, as well as granule structure using SEM Imaging. • Wet granulation and fluid bed drying: Concluded that the biggest control over, the measured mean granule size (d50) produced from the combined system was still the ratio of water to dry powder in the wet granulation. • Wet granulation through to compression: The effects of changes in the granulation process were not statically relevant on the final tablet for the process set up. The study also used PEPT data to assess motion within the TSG. The studies showed: • The time spent in the kneading zone directly after the liquid addition in relation to the overall time spent in the granulation process appears independent of the process j . set up at 32% ± 2%. • As the barrel speed of the granulator increases the relative time spent in the final ' breakage zone' of the TSG increases, therefore increasing breakage. Using the findings from the literature, the results of the experimental program were used to define the mechanisms occurring within the TSG. The experimental findings were input into a model to predict the outcome of collisions between particles. The model predicts agglomeration of the smaller particles to the larger ones and by calculating changes in the viscosity of the binder the subsequent secondary agglomeration of these granules can also be shown using this model The model is limited due to assumptions in deriving it. The model excludes capillary forces that if given sufficient time to form could have the same order of magnitude strength as other forces.

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Wilburn, Kristopher Ray. « The business case for continuous manufacturing of pharmaceuticals ». Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/59190.

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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Global Operations Program at MIT, 2010.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 52-53).
Manufacturing in the pharmaceutical industry is presently characterized as a batch production system, which has existed in its current form for decades. This structure is the result of historical regulatory policy as well as the conservative nature of the industry. Recent clarification by US and European regulatory bodies has opened the possibility to new approaches to the manufacturing process. This combined with changes in the market for the pharmaceutical industry has accelerated the rate at which new manufacturing technologies are explored. Continuous manufacturing is a paradigm shift in the pharmaceutical industry manufacturing structure, encompassing several new technologies and systems. The business impact of continuous manufacturing has not been well defined. This assessment aims to compare a continuous manufacturing process to a batch manufacturing process for a particular Novartis product. The product has an established batch production process. Cost estimates and the continuous process cost is estimated using a four-step process: defining the process flow, performing the material balance, estimating the capital costs, and estimating the operating costs. This analysis shows that for the particular Novartis product considered, a continuous process is an improvement over the batch process in four performance characteristics: capital investment, operating cost, throughput time, and working capital requirement.
by Kristopher Ray Wilburn.
S.M.
M.B.A.

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Livres sur le sujet "Continuous pharmaceutical manufacturing"

Subramanian, Ganapathy, dir. Continuous Processing in Pharmaceutical Manufacturing. Weinheim, Germany : Wiley-VCH Verlag GmbH & Co. KGaA, 2014. http://dx.doi.org/10.1002/9783527673681.

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Alper, Joe, dir. Continuous Manufacturing for the Modernization of Pharmaceutical Production. Washington, D.C. : National Academies Press, 2019. http://dx.doi.org/10.17226/25340.

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Khinast, Johannes, et Jukka Rantanen. Continuous Manufacturing of Pharmaceuticals. Sous la direction de Peter Kleinebudde. Chichester, UK : John Wiley & Sons, Ltd, 2017. http://dx.doi.org/10.1002/9781119001348.

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Kleinebudde, Peter, Johannes Khinast et Jukka Rantanen. Continuous Manufacturing of Pharmaceuticals. Wiley & Sons, Incorporated, John, 2017.

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Kleinebudde, Peter, Johannes Khinast et Jukka Rantanen. Continuous Manufacturing of Pharmaceuticals. Wiley & Sons, Incorporated, John, 2017.

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Douroumis, Dionysios, Peter Kleinebudde, Johannes Khinast, Jukka Rantanen et Martin J. Snowden. Continuous Manufacturing of Pharmaceuticals. Wiley & Sons, Limited, John, 2017.

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Kleinebudde, Peter, Johannes Khinast et Jukka Rantanen. Continuous Manufacturing of Pharmaceuticals. Wiley & Sons, Limited, John, 2017.

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Subramanian, Ganapathy. Continuous Processing in Pharmaceutical Manufacturing. Wiley-VCH Verlag GmbH, 2014.

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Subramanian, Ganapathy. Continuous Processing in Pharmaceutical Manufacturing. Wiley & Sons, Incorporated, John, 2014.

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Subramanian, Ganapathy. Continuous Processing in Pharmaceutical Manufacturing. Wiley & Sons, Limited, John, 2014.

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Chapitres de livres sur le sujet "Continuous pharmaceutical manufacturing"

Johnson, Martin D., Scott A. May, Michael E. Kopach, Jennifer Mc Clary Groh, Timothy Donald White, Kevin P. Cole, Timothy Braden, Luke P. Webster et Vaidyaraman Shankarraman. « Continuous Reactors for Pharmaceutical Manufacturing ». Dans Continuous Pharmaceutical Processing, 23–50. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_2.

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Ganesh, Sudarshan, et Gintaras V. Reklaitis. « Basic Principles of Continuous Manufacturing ». Dans Continuous Pharmaceutical Processing, 1–21. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_1.

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Morefield, Elaine. « Regulatory Considerations for Continuous Manufacturing ». Dans Continuous Pharmaceutical Processing, 513–35. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_15.

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Su, Qinglin, Gintaras V. Reklaitis et Zoltan K. Nagy. « Continuous Feeding-Blending in Pharmaceutical Continuous Manufacturing ». Dans Continuous Pharmaceutical Processing, 193–226. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_6.

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Giridhar, Arun, et Gintaras V. Reklaitis. « Real-Time Optimization : How to Change Setpoints in Pharmaceutical Manufacturing ». Dans Continuous Pharmaceutical Processing, 429–40. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_12.

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Johnson, Martin D., Scott A. May, Jennifer McClary Groh, Timothy Braden et Richard D. Spencer. « Intermittent Flow and Practical Considerations for Continuous Drug Substance Manufacturing ». Dans Continuous Pharmaceutical Processing, 87–127. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_4.

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Su, Qinglin, Sudarshan Ganesh, Gintaras V. Reklaitis et Zoltan K. Nagy. « Active Process Control in Pharmaceutical Continuous Manufacturing – The Quality by Control (QbC) Paradigm ». Dans Continuous Pharmaceutical Processing, 395–427. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_11.

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Srai, Jagjit Singh, Ettore Settanni et Parminder Kaur Aulakh. « Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals : A Supply Network Perspective ». Dans Continuous Pharmaceutical Processing, 477–512. Cham : Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-41524-2_14.

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Steiner, Richard, et Maik Jornitz. « Continuous Processing in the Pharmaceutical Industry : Status and Perspective ». Dans Continuous Manufacturing of Pharmaceuticals, 369–403. Chichester, UK : John Wiley & Sons, Ltd, 2017. http://dx.doi.org/10.1002/9781119001348.ch11.

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Borukhova, Svetlana, et Volker Hessel. « Continuous Manufacturing of Active Pharmaceutical Ingredients via Flow Technology ». Dans Continuous Manufacturing of Pharmaceuticals, 127–67. Chichester, UK : John Wiley & Sons, Ltd, 2017. http://dx.doi.org/10.1002/9781119001348.ch4.

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Actes de conférences sur le sujet "Continuous pharmaceutical manufacturing"

Schenkendorf, Rene. « Supporting the shift towards continuous pharmaceutical manufacturing by condition monitoring ». Dans 2016 Conference on Control and Fault-Tolerant Systems (SysTol). IEEE, 2016. http://dx.doi.org/10.1109/systol.2016.7739813.

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Ohtake, S., A. Langford et B. Luy. « Current needs of the pharmaceutical industry : opportunities and challenges for implementing novel drying technologies ». Dans 21st International Drying Symposium. Valencia : Universitat Politècnica València, 2018. http://dx.doi.org/10.4995/ids2018.2018.8354.

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Commercial drying methods are limited either by high production costs or significant quality loss due to process-related stresses. The near-ubiquitous use of freeze-drying in the pharmaceutical industry makes it the standard to which other drying technologies are compared. However, the shortcomings of lyophilization warrant evaluation of new techniques and the benefits they offer, such as compatibility with continuous manufacturing. Novel drying technologies must also overcome barriers to commercial implementation including, but not limited to, scalability and integration into a GMP environment. There remain several opportunities for further research which direct focus and investment strategy for the next generation pharmaceutical drying technologies. Keywords: pharmaceuticals; manufacturing technology; implementation; lyophilization; scalability

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Nikolakopoulou, Anastasia, Matthias von Andrian et Richard D. Braatz. « Plantwide Control of a Compact Modular Reconfigurable System for Continuous- Flow Pharmaceutical Manufacturing ». Dans 2019 American Control Conference (ACC). IEEE, 2019. http://dx.doi.org/10.23919/acc.2019.8814781.

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Elkhashap, Ahmed, Robin Meier et Dirk Abel. « A Grey Box Distributed Parameter Model for a Continuous Vibrated Fluidized Bed Dryer in Pharmaceutical Manufacturing ». Dans 2020 European Control Conference (ECC). IEEE, 2020. http://dx.doi.org/10.23919/ecc51009.2020.9143770.

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Nikolakopoulou, Anastasia, Matthias von Andrian et Richard D. Braatz. « Fast Model Predictive Control of Startup of a Compact Modular Reconfigurable System for Continuous-Flow Pharmaceutical Manufacturing ». Dans 2020 American Control Conference (ACC). IEEE, 2020. http://dx.doi.org/10.23919/acc45564.2020.9147331.

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Scholl, Stephan. « From Batch to Continuous Production Through Micro Process Technology : Chances and Challenges ». Dans ASME 2008 6th International Conference on Nanochannels, Microchannels, and Minichannels. ASMEDC, 2008. http://dx.doi.org/10.1115/icnmm2008-62028.

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The majority of the manufacturing processes in the chemical, pharmaceutical, food or cosmetics industry is operated as batch processes. This is economically advantageous in cases where - capacities per product are low, in the range of 10 kg/a to 1000 t/a - many different educts have to be mixed and processed for the product, i.e. a recipe-based manufacturing, - many different but similar products have to be produced, - educts have to be fed at different times and with varying quantities, - educts show problematic properties such as high viscosity, solids or stickiness, - problematic processing behaviour such as fouling, foaming, viscous intermediate phases or undesired precipitation, is found, - manufacturing has to meet a sometimes stochastic market demand or - the process consist of only a few process steps like mixing, heating, reaction and cooling.

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Nelson, Cartwright, Slesha Tuladhar et Md Ahasan Habib. « Designing an Interchangeable Multi-Material Nozzle System for 3D Bioprinting Process ». Dans ASME 2021 16th International Manufacturing Science and Engineering Conference. American Society of Mechanical Engineers, 2021. http://dx.doi.org/10.1115/msec2021-63471.

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Abstract Three-dimensional bioprinting is a rapidly growing field attempting to recreate functional tissues for medical and pharmaceutical purposes. Development of functional tissue requires deposition of multiple biomaterials encapsulating multiple cell types i.e. bio-ink necessitating switching ability between bio-inks. Existing systems use more than one print head to achieve this complex interchangeable deposition, which decreases efficiency, structural integrity, and accuracy. In this research, we developed a nozzle system capable of switching between multiple bio-inks with continuous deposition ensuring the minimum transition distance so that precise deposition transitioning can be achieved. Finally, the effect of rheological properties of different bio-material compositions on the transition distance is investigated by fabricating the sample scaffolds.

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Schoenitz, Martin, Annika Hohlen, Wolfgang Augustin et Stephan Scholl. « In-Process Cleaning of a Micro Heat Exchanger With Ultrasound During the Continuous Crystallization of Solid Lipid Nanoparticles ». Dans ASME 2014 12th International Conference on Nanochannels, Microchannels, and Minichannels collocated with the ASME 2014 4th Joint US-European Fluids Engineering Division Summer Meeting. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/icnmm2014-21821.

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Process intensification by the application of microscale process engineering in reaction and heat transfer processes provides the opportunity of moving from batch to continuous manufacturing, mainly due to enhanced heat and mass transfer. These effects are primarily caused by the very high surface to volume ratio in microstructured devices. Further advantages, particularly suitable for sensitive products, are the low shear stress in the typically occurring laminar regime and the short residence time. The crystallization of drug carrying lipid nanoparticles (LNP) is a typical batch process for pharmaceutical products and is used here to demonstrate benefits, challenges and application possibilities of the conversion into a continuous microscale process. During the continuous crystallization of various LNP formulations in a micro-crystallizer, designed as a micro heat exchanger with square channels, several formulations led to fouling and blocking of small passages in the micro heat exchanger. To investigate the fouling behavior of different LNP formulations in detail, integral pressure drop measurements over the micro heat exchanger were performed. This contribution addresses the in-process cleaning of a micro heat exchanger for the continuous crystallization using ultrasound. Different ultrasound amplitudes and operation procedures were investigated. During processing the overall pressure drop was decreased significantly by induced ultrasound pulses. The investigations showed that in-process cleaning of a micro heat exchanger with ultrasound is possible for screening as well as for long term production of LNP. Also the product quality, given by the particle size and particle size distribution, is not affected by the ultrasound input.

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Mustafa, Khalid, et Kai Cheng. « Managing Complexity in Manufacturing Changeovers : A Sustainable Manufacturing-Oriented Approach and the Application Case Study ». Dans ASME 2016 11th International Manufacturing Science and Engineering Conference. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/msec2016-8744.

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Increasing manufacturing complexity continues to be one of the most significant challenges facing the manufacturing industry today. Due to these rapid changes in manufacturing systems, one of the most important factors affecting production is recognized as the frequent production setup or changeovers, consequently affecting the overall production lead times and competitiveness of the company. Developing responsive production setup and process capability is increasingly important as product ranges and varieties in manufacturing companies are growing rapidly and, at the same time, production business models are operating more towards being customer-oriented. Furthermore, although different conventional methods have been used to manage complexity in production changeovers, sustainability and competitiveness development in a manufacturing company needs to be scientifically addressed by managing manufacturing complexity. In this paper, a sustainable manufacturing-oriented approach is presented in mind of managing manufacturing changeover complexities. A case study is carried out specifically concerning changeover complexity in a pharmaceutical company, aiming at minimizing complexities in production changeover and waste, increasing plant flexibility and productivity, and ultimately the sustainable competitiveness of the company in managing manufacturing changes.

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Fritsch, Klaus. « GWP® - The Science-Based Global Standard for Efficient Lifecycle Management of Weighing Systems ». Dans NCSL International Workshop & Symposium. NCSL International, 2012. http://dx.doi.org/10.51843/wsproceedings.2012.22.

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In the pharmaceutical laboratory, weighing is only one step of a whole analysis chain in drug discovery and quality control; however it strongly influences the overall quality and integrity of the final result. Also in production, weighing is decisive to achieve batch uniformity and consistency, e.g. in dispensing or formulation processes. For the food industry, accurate weighing processes also act as an important contribution for two of its most demanding challenges: Increasing public health and consumer safety, and increasing productivity and competitiveness. The same or similar issues are also prevalent in other industries as the chemical, fragrance or automotive industry, and also apply for testing labs and companies focusing on contract research and manufacturing. Everywhere, accurate weighing is essential to ensure continuous adherence to predefined process requirements and to avoid a frequent source of Out of Specification results (OOS). This article introduces GWP®, a science-based global standard for efficient lifecycle management of weighing systems. It consists of the selection of the appropriate weighing system based on the evaluation of the respective weighing process requirements, and provides scientific guidance to the user regarding calibrating and testing weighing instruments during the instrument's lifecycle. Based primarily on the user’s weighing requirements and prevailing weighing risks, it provides a state-of-the-art strategy to reduce measurement errors and to ensure reproducibly accurate weighing results. The understanding of the particular weighing process requirements and important balance and scale properties as minimum weight is essential to select an appropriate weighing system in the framework of the design qualification. The performance qualification takes into account these requirements and risks to establish a specific routine testing scenario for the instrument. The higher the impact in case of inaccurate weighings, and the more stringent the weighing accuracy requirements are the more frequently calibration and user tests have to be carried out. However, for less risky and stringent applications, testing efforts can be reduced accordingly. Risk- and life cycle management form an integrated part of the overall strategy of GWP® to bridge the gap between regulatory compliance, process quality, productivity and cost consciousness.

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Rapports d'organisations sur le sujet "Continuous pharmaceutical manufacturing"

Agu, Monica, Zita Ekeocha, Stephen Robert Byrn et Kari L. Clase. The Impact of Mentoring as a GMP Capability Building Tool in The Pharmaceutical Manufacturing Industry in Nigeria. Purdue University, décembre 2012. http://dx.doi.org/10.5703/1288284317447.

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Good Manufacturing Practices (GMP), a component of Pharmaceutical Quality Systems, is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Provision of adequate number of personnel with the necessary qualifications/practical experience and their continuous training and evaluation of effectiveness of the training is the responsibility of the manufacturer. (World Health Organization [WHO], 2014; International Organization for Standardization [ISO], 2015). The classroom method of training that has been used for GMP capacity building in the pharmaceutical manufacturing industry in Nigeria over the years, delivered by experts from stringently regulated markets, have not yielded commensurate improvement in the Quality Management Systems (QMS) in the industry. It is necessary and long over-due to explore an alternative training method that has a track record of success in other sectors. A lot of studies carried out on mentoring as a development tool in several fields such as academia, medicine, business, research etc., reported positive outcomes. The aim of this study was to explore mentoring as an alternative GMP training method in the pharmaceutical manufacturing industry in Nigeria. Specifically, the aim of this study was to evaluate the impact of mentoring as a GMP capability building tool in the pharmaceutical manufacturing industry in Nigeria, with focus on GMP documentations in XYZ pharmaceutical manufacturing company located in South-Western region of Nigeria. The methodology comprised gap assessment of GMP documentation of XYZ company to generate current state data, development of training materials based on the identified gaps and use of the training materials for the mentoring sessions. The outcome of the study was outstanding as gap assessment identified the areas of need that enabled development efforts to be targeted at these areas, unlike generic classroom training. The mentees’ acceptance of the mentoring support was evident by their request for additional training in some other areas related to the microbiology operations that were not covered in the gap assessment. This result portrays mentoring as a promising tool for GMP capacity building, but more structured studies need to be conducted in this area to generate results that can be generalized.

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