The manufacturing and logistics processes for small volumes of ATMPs are complex, and there are still weaknesses, particularly in the areas of inter-site transportation, aseptic aliquotation and cryopreservation. All process steps in fluid and cold chain management require robustness, ease of use, sterility and fast handling.
New Strategies for a Better Glycosylation Profile
January 22nd 2025Glycan 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.