GMP Cleanroom Routine Environmental Monitoring & Data Integrity
Routine Environmental Monitoring in GMP cleanrooms is a manual process and can be complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and integrity challenges. This paper shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can be automated to help manage these challenges.
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.
