Search results for " CMC"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Products,” presentation at 2010 WCBP CMC Strategy Forum (Bethesda, MD, 2010).
11. L. Zang, X. L. Hronowski, Y. Lyubarskay…
Article
Climate Change in Outsourcing
Fork in the CMC road. The desire to reduce the cost and risk of R&D has led bio/pharma companies of all sizes to embrace the proof-of-concept (POC) model, which calls for minimizing development effort…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
…James Schmid, and Michael Larson are development associates, all in the Process Development Group at CMC Biologics, http://www.cmcbio.com/.
REFERENCES
1. FDA, Draft Guidance for Industry: T…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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What is process development?
And if you make changes to your manufacturing process during clinical trials, this could impact regulatory CMC (chemistry, manufacturing, and controls) submissions and could have a negative effect on …
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
The CMC journey is complex with many stages such as functional groups.
Jeanne Linke Northrop: Are there special skills required by that person to define that scaling strategy?
Andr…
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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
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Reimagining Affordable Biosimilars
Geigert, “Complex Process-Related Impurity Profiles,” In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Springer, Cham, Switzerland, 3rd ed., 2019), pp. 231-260
J. Gokemeije…
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Eliminating Residual Impurities Starts with a Strategic Plan
“Although full CMC [chemistry, manufacturing, and controls] information is not required until the market application dossier is submitted, a useful strategy is to prepare a comprehensive report that d…
Article
Improving Upstream Predictability
Erickson sees this effort as being similar in spirit to work on the “A-mAb” case study for quality by design that was done over 10 years ago by the CMC Biotech Working Group (2).
Further out…