Search results for " CMC"
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Accelerating CMC - The future of process development is in silico
In this session, you’ll gain insight on how to apply simulation in your CMC activities, including case studies of the successful use of simulation in biopharmaceutical process development.
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Quality by design for biotechnology products—part 1
…s and comparability, comparability protocols and expanded change protocols, marketed products, and a CMC post-approval management plan. It also includes the overall conclusions.
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Manufacturers Struggle with Breakthrough Drug Development
Consequently, FDA officials urge manufacturers with a newly designated breakthrough to meet early with CMC reviewers to discuss strategies for ensuring product quality, including development of stabil…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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Being Thorough When Transferring Technology
…n Moscariello, vice-president, process development, and Jeremy Young, director, process transfer, at CMC Biologics Seattle.
The challenges of scale up and tech transfer of biologics
Bio…
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Modern Manufacturing Key to More Effective Vaccines
…er, Levis noted that there may be flexibility when combating epidemics, such as accepting supportive CMC data from platform-related products and specifications based on related products. Test vaccine…
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Quality Systems Key to Lifecycle Drug Management
Pfizer is involved with some 24,000 postapproval changes a year for its 30,000 products, noted vice-president Roger Nosal at the April 2015 CMC Workshop sponsored by the Drug Information Association (…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Phase-appropriate strategy for characterization of transgenes expressed in CHO cells
The CMC development phases discussed in this manuscript refer to the three phases commonly associated with clinic…
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Transformative Medicines Challenge FDA and Manufacturers
Development involves controlling for impurities in clinical supplies and establishing CMC strategies for global product development, he observed. And process scale-up further requires identification a…
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Efforts Accelerate to Streamline Postapproval Change Process
She and others described efforts to streamline this cumbersome and costly postapproval change process at the July 2016 CMC Strategy Forum on “Change Happens” organized by CASSS.
Gaining regulatory…