Search results for "2014"
Article
Quality Systems Key to Lifecycle Drug Management
FDA issued a guidance in March 2014 that sought to expand the range of manufacturing changes that can be documented in annual reports, but the list was fairly limited, and industry has found it incons…
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Modular Manufacturing Platforms for Biologics
in 2014, was established with Defense Department funding from the Defense Advanced Research Projects Agency (DARPA) to be able to respond to biological and pandemic threats. Caliber has received inqui…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
104 (2) 666-677 (November 2014).
6. FDA, Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (Rockville, MD, August 2014).
Article Details
BioPharm Internatio…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
12 (4) 18-21 (2014).
3. H.F. Giles, E.M. Mount, and J.R. Wagner, The Definitive Processing Guide and Handbook, Part 6: Coextrusion, Coextrusion Applications (William Andrew Inc., NY, NY, 2005), pp…
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Continued Process Verification for Biopharma Manufacturing
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
Volume 27, Issue 10, pp. 48-52
Continued process verification (CPV) is the activity that provides ongoing verification…
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Application of Quality by Design to Viral Safety
Oct 1, 2014
BioPharm International
Volume 27, Issue 10, pp. 40-47
The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceutical…
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Evaluating Design Margin, Edge of Failure and Process
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or process’ design space is generally considered to be the area where process p…
Article
Global Expansion Shapes Drug Oversight
At the annual meeting of the Food and Drug Law Institute (FDLI) in April 2014, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
A hearing is scheduled for February 28, 2014.
Impact of the approval of infliximab
The EU approval of Celltrion’s and Hospira’s mAb biosimilar infliximab (Remsima/Inflectra) is an important mile…
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Q&A with Industry Leaders: Rita Peters
Q: What trends have you seen in the drug development market as 2014 enters the second quarter?
A; At recent industry conferences and trade shows for pharmaceutical development, both educational se…