Scale-Up of Cold-chain Operations in API Development
An examination of Novel gene therapy development, understanding the biologic, the materials it contacts and intricacies of equipment, service offerings and partners to ensure effective cold-chain scale-up in cryogenic operations.
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New Strategies for a Better Glycosylation Profile
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Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
