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Utilizing PAT to Monitor and Control Bulk Biotech Processes
| Contributor(s):: Rick E. Cooley
1.What is and isn’t PAT? 2.Implementing PAT in Manufacturing: What does it take? 3.Characteristics of bulk, biotech API processes 4.Why PAT? 5.Review of PAT technologies utilized 6.PAT application examples
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Towards Continuous Primary Manufacturing Processes-Particle Design through Combined Crystallization and Particle Isolation
| Contributor(s):: Steenweg, C, Kufner, ACHabicht, J, Wohlgemuth, K
Integrated continuous manufacturing processes of active pharmaceutical ingredients (API) provide key benefits concerning product quality control, scale-up capability, and a reduced time-to-market. Thereby, the crystallization step, which is used in approximately 90% of API productions, mainly...
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Separation and Purification in the Continuous Synthesis of Fine Chemicals and Pharmaceuticals
| Contributor(s):: O'Mahony, M, Ferguson, SStelzer, T, Myerson, A
The use to both chemists and chemical engineers working in flow synthesis, this chapter provides a summary of separation and purification operations that can be applied to flow synthesis reaction streams. Both single and biphasic separations for the liquid phase are detailed. Separation and...
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Modelling for Bio-, Agro-and Pharma-Applications
| Contributor(s):: Rodriguez, Ricardo Morales, Singh, Ravendra Cameron, Ian Gani, Rafiqul
This chapter considers a range of modelling applications drawn from biological, agrochemical and pharma fields. Microcapsule controlled release of an active ingredient is considered through a time dependent model. Burst-time and lag-time effects are considered and the model adopts a multiscale...
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End-to-end continuous manufacturing of conventional compressed tablets: From flow synthesis to tableting through integrated crystallization and filtration
| Contributor(s):: Domokos, A, Nagy, BGyurkes, M, Farkas, A, Tacsi, K, Pataki, H, Liu, YC, Balogh, A, Firth, P, Szilagyi, B, Marosi, G, Nagy, ZK
An end-to-end continuous pharmaceutical manufacturing process was developed for the production of conventional direct compressed tablets on a proof-of-concept level for the first time. The output reaction mixture of the flow synthesis of acetylsalicylic acid was crystallized continuously in a...
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A Novel Integrated Workflow for Isolation Solvent Selection Using Prediction and Modeling
| Contributor(s):: Ottoboni, S, Wareham, BVassileiou, A, Robertson, M, Brown, CJ, Johnston, B, Price, CJ
A predictive tool was developed to aid process design and to rationally select optimal solvents for isolation of active pharmaceutical ingredients. The objective was to minimize the experimental work required to design a purification process by (i) starting from a rationally selected...