Search results for " industry" in Articles / App Notes
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Recombinant protein production in the biopharmaceutical industry mostly relies on fed-batch mammalian cell culture (1, 2). Often in fed-batch processes, the feed volume can be more than 1000 L for a 5…
Article
Manufacturers Struggle with Breakthrough Drug Development
It’s a sign of strong industry interest in developing new drugs with accelerated, abbreviated pathways, even if indicated for small patient populations.
Janet Woodcock, director of the Center fo…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
FDA, Guidance for Industry, Process Validation: General Principles and Practices, Revision 1 (Rockville, MD, January 2011).
2. ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Developme…
Article
Drugs, At What Cost?
The report identifies challenges, but also indicates opportunities for the industry to improve the lives of patients.
In 2012, developed markets (United States, Japan, Germany, France, Italy, S…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
Commercial-scale production challenges
The rapid growth in mAb demand has triggered industry efforts to increase manufacturing capacity, with the consequence that the antibody titers in mammalia…
Article
Evolution of the Monoclonal Antibody Purification Platform
It has been more than a decade since the industry started establishing the process platform. This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the puri…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Operational Excellence: More Than Just Process Improvement
To tackle human-error-caused deviations, the deviation management process was redesigned to bring it into line with current FDA expectations and industry best practices, and to assure that the people …
Article
Essentials in Establishing and Using Design Space
FDA, Guidance for Industry, Process Validation: General Principles
and Practices (2011).
3. S. Chatterjee, “Design Space Considerations,” FDA, AAPS Annual Meeting, October 14, 2012, Chicago, O…
Article
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…