COMMISSIONING AND QUALIFICATION OF BIOPHARMACEUTICAL CLEANROOMS

Combining on- and off-site construction approaches reduces project risk while offering benefits to schedule, flexibility, and cost of ownership for new cleanroom construction.

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.