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Olena Gligorich
Olena brings over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable...
https://cmkc.usp.org/members/2480
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Residence Time Distribution - Test Example
| Contributor(s):: RCPE
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MOOC I Control Strategy - Model-Based Control
| Contributor(s):: RCPE
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MOOC 1 Tracer Test for RTD Measurement
| Contributor(s):: RCPE
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MOOC 1 Residence Time Distribution
| Contributor(s):: RCPE
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Kirti Narsai
Kirti has 25 years’ experience in the healthcare industry and held board positions in several large organisations with Pan African interests & was a member of the African Regional...
https://cmkc.usp.org/members/1149
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RTD-based material tracking in a fully-continuous dry granulation tableting line
| Contributor(s):: Martinetz, M. C., Karttunen, A-P, Sacher, S., Wahl, P., Ketolainen, J., Khinast, J. G., Korhonen, O
Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control...
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Process Model for Enhancing Yield in Sterile Drug Product Manufacturing
| Contributor(s):: Yabuta, K, Hirao, M, Sugiyama, H
We present a process model for enhancing the yield in the manufacturing of sterile drug products, such as injectables, eye drops, or intravenous bags. The process typically consists of compounding, filtration, filling, and visual inspection and involves raw materials of active pharmaceutical...
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Predicting Pharmaceutical Particle Size Distributions Using Kernel Mean Embedding
| Contributor(s):: Van Hauwermeiren, Daan, Stock, Michiel, De Beer, Thomas, Nopens, Ingmar
In the pharmaceutical industry, the transition to continuous manufacturing of solid dosage forms is adopted by more and more companies. For these continuous processes, high-quality process models are needed. In pharmaceutical wet granulation, a unit operation in the ConsiGmaTM-25 continuous...
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Population Balance Modeling to Predict Particle Size Distribution upon Scale-Up of a Combined Antisolvent and Cooling Crystallization of an Active Pharmaceutical Ingredient
| Contributor(s):: Rosenbaum, Tamar, Tan, Li Dummeldinger, Michael Mitchell, Niall, Engstrom, Joshua
Herein, a population balance model (PBM) for a combined cooling and antisolvent crystallization process for an active pharmaceutical ingredient (API) has been developed and utilized to predict the product particle size distribution (PSD) for two sets of four ∼35 kg scale plant batches, with...
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Parametric Study of Residence Time Distributions and Granulation Kinetics as a Basis for Process Modeling of Twin-Screw Wet Granulation
| Contributor(s):: Plath, Timo, Korte, Carolin, Sivanesapillai, Rakulan, Weinhart, Thomas
Twin-screw wet granulation is a crucial unit operation in shifting from pharmaceutical batch to continuous processes, but granulation kinetics as well as residence times are yet poorly understood. Experimental findings are highly dependent on screw configuration as well as formulation, and thus...
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Improving Pellet Quality in a Pharmaceutical Hot Melt Extrusion Process via PID Control and LOLIMOT-Based MPC
| Contributor(s):: Rehrl, J, Kirchengast, MCelikovic, S, Sacher, S, Kruisz, J, Khinast, J, Horn, M
Purpose The aim of this paper is the development of a process control concept for a hot melt extrusion (HME) and pelletization process. The new concept should improve the particle size distribution of the pellets produced. Methods Production of pellets containing an active pharmaceutical...
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Crystal shape and size control using a plug flow crystallization configuration
| Contributor(s):: Sang-Il Kwon, Joseph, Nayhouse, Michael Orkoulas, Gerassimos
This work focuses on modeling and control of a continuous plug flow crystallizer (PFC) used to produce tetragonal hen-egg-white (HEW) lysozyme crystals and proposes an optimization-based control scheme to produce crystals with desired size and shape distributions in the presence of disturbances....
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Comprehensive modelling of pharmaceutical solvation energy in different solvents
| Contributor(s):: Panwar, A, Shirazian, SSingh, M, Walker, GM
Crystallization is an important processing step in production of active pharmaceutical ingredients (API). This process is used to recover/separate the synthesized APIs for further processing to final solid dosage oral formulations. Control and understanding of crystallization are of great...
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A Virtual Plant for Integrated Continuous Manufacturing of a Carfilzomib Drug Substance Intermediate, Part 1: CDI-Promoted Amide Bond Formation
| Contributor(s):: Içten, Elçin, Maloney, Andrew J., Beaver, Matthew G., Shen, Dongying E., Zhu, Xiaoxiang, Graham, Lauren R., Robinson, Jo A., Huggins, Seth, Allian, Ayman, Hart, Roger, Walker,Shawn D., Rolandi, Pablo, Braatz, Richard D.
This article details process characterization efforts and the development of corresponding process models to inform a process control strategy to produce a carfilzomib drug substance intermediate, morpholine amide 3. Model calibration for relevant unit operations and development of a dynamic...