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Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
Published on: May 18, 2020
Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the
Glenn A Van Buskirk1, Satish Asotra, Christopher Balducci
1Nonclinical Drug Development Consulting Services, LLC, Basking Ridge, New Jersey, 07920, USA, glennvb@optonline.net.
Abstract:
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
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