"The reason for assessing the critical quality attributes is not only to fulfill an expectation, but also because it serves as a better understanding of the product under development"
IBC's 18th Annual TIDES is the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization. The TIDES team recently talked to Renata Varga, Ph.D., Scientist - Characterization, Analytical Sciences, Global Biological CMC, Teva Pharmaceutical for an exclusive interview that delves into the topics he plans to discuss at the upcoming Oligonucleotide and Peptide Therapeutics event in Long Beach, CA.
In this interview, Dr. Varga discusses;
- The key regulatory challenges facing peptide developers
- What regulators look for when establishing CQAs in genetics, and any variation between generics and novel therapeutics.
- Peptide innovation in the next 5 years
From Critical Quality Attribute Assessment to Specification and Characterization
Characterization and comparability assessment of peptide based generic products is driven by critical quality attributes (CQAs). Standard CQAs are identified based on regulatory requirements. Additional CQAs are determined by understanding the molecule itself: sensitive amino acids or which are involved in receptor-binding or mechanism of activation, are identified and based on uncertainty and impact the criticality of that attribute is defined. All standard- and additional CQAs are included in the specification while potential CQAs are further characterized by orthogonal techniques.
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