Search results for " guide" in Articles / App Notes
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Test procedures and acceptance criteria for CQA analysis have been described in regulatory guidelines for biotechnological/biological products (6, 7).
Late-stage development starts with set up and…
Article
USP Stresses Pharmacopeial Standards at CPhI China
“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply, and also guide them to contribut…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Wagner, The Definitive Processing Guide and Handbook, Part 6: Coextrusion, Coextrusion Applications (William Andrew Inc., NY, NY, 2005), pp. 372-389.
4. M.A. Ruberto, “Polymers and additives used …
Article
Challenges in Analytical Method Development and Validation
A suitable protocol may be needed to guide the receiving labs to generate similar forced degradation samples themselves.
Krumenaker (West-Ward): When transfers are being done between sites, or with…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
…ll need to look at how they use in-market data to influence new study design and provide insights to guide future product development.
• Market access teams will become increasingly important as t…
Article
Supplier-Change Management for Drug-Product Manufacturers
The International Pharmaceutical Excipients Council of the Americas, Significant Change Guide for Bulk Pharmaceutical Excipients, Revision 2, March 2009.
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
Article
The Lifecycle Change of Process Validation and Analytical Testing
The implementation of the new FDA guidelines on process validation will not only meet the expectations of the regulator but can also ensure the success of business demands such as lean scale-up, comme…
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).
--
Note: This article was fi…