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FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications

As methods and technologies designed to unravel the complexities and intricacies of protein folding, three-dimensional structure and function become more reliable and available, FDA is looking at whether it is time to begin requiring more detailed information on higher order protein structure in biotech product applications....

Uncertainties in Subvisible Particulates Need to Be Understood, FDA Tells Biotech CMC Strategy Forum

The uncertainties around subvisible particles (SVPs) may warrant their being controlled as a critical quality attribute, FDA Office of Biotechnology Products Division of Therapeutic Proteins (DTP) Deputy Director Barry Cherney stressed at a CASSS/FDA CMC Strategy Forum in Washington, D.C in January....

Immunogenic Potential of Aggregates Affirmed at Biotech CMC Forum

The clear potential for aggregates of subvisible particles (SVPs) to cause immunogenic responses in both animals and humans was affirmed at the biotech “CMC Strategy Forum” held in Washington, DC, in mid-January.

Particulates in Biotech Products: Standard Setting Effort Gaining Traction

Visible and sub-visible particles in parenteral products and the need for developing measurement standards is drawing attention from regulators and industry at biotech conferences....
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