Search results for " BLA"
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
Regulatory Challenges in the QbD Paradigm
On inspection, OBP assesses product-specific elements, verifies data and conformance to commitments in the BLA or supplement. BMAB provides a microbiology quality assessment of drug substance and drug…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
Understanding Validation and Technical Transfer, Part 3
How often following some deviation or FDA 483 observation is the first impulse to blame an operator for the occurrence and the proposed corrective action to retrain the individual? Sometimes this is j…
Article
Process Development: What May Lie Ahead in 2018?
Readers were very interested to learn how to prevent bioburden incidents in this article written by a former FDA BLA reviewer and inspector. Also hot was a second piece on protecting against microbiol…
Article
Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
Article
Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…