Newswise — ARLINGTON, VA. (May 17, 2018) – A new open-access white paper discusses how to identify, measure and assess the critical product attributes for a proposed biosimilar product. The proposed methodology was described by an international, multidisciplinary team involving FDA and pharmaceutical industry experts, and The American Association of Pharmaceutical Scientists (AAPS), which published the paper today in The AAPS Journal.
“We lay out the emerging ‘gold standard’ approach and illustrate the concepts discussed with examples from successful applications,” say coauthors Kristof Vandekerckhove and Henriette Kuehne, Ph.D.
The paper, entitled “Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars,” includes case examples and a list of commonly used analytical methods to illustrate current practices and aid the development of biosimilar products.
This whitepaper was prepared under the auspices of the AAPS Biosimilars focus group’s Chemistry Manufacturing and Controls Analytical (CMC-A) subcommittee.
* * *
About AAPS: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organization of approximately 9,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS advances the capacity of pharmaceutical scientists to develop products and therapies that improve global health. Visit www.aaps.org and follow us on LinkedIn, Facebook, and Twitter @AAPSComms. The official Twitter hashtag for AAPS is: #AAPS2018.
RSS