Search results for " pharmaceutical" in Articles / App Notes
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Joerg Windisch, EBG chair and chief science officer of Sandoz Pharmaceuticals, stressed that comparability between biosimilars and their reference products included having similar variabilities, parti…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A team from Chugai Pharmaceutical (Japan) investigated the mAb purification performance of a new alkali-tolerant, prototype Protein A resin (Resin 3, MabSelect SuRe LX prototype, Cytiva), which has th…
Article
Essentials in Establishing and Using Design Space
ICH, Q8(R2) Pharmaceutical Development (2009).
2. FDA, Guidance for Industry, Process Validation: General Principles
and Practices (2011).
3. S. Chatterjee, “Design Space Considerations,” …
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
ICH, Q8 (R2) Pharmaceutical Development, Step 4 version (2009).
3. A. Brindle, et al., Pharm. Eng. 32 (1) 26, 28-33 (2012).
Article
PDA's Technical Report for Biotech Cleaning Validation
ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 4 version (2000).
6. ICH, Q9 Quality Risk Management, Step 4 version (2005).
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Note: This article was fi…