Standarization for Biologics Stability Testing
Solving Biologics-specific Challenges Demands a Unified Approach
To stay competitive, today’s life science firms need to implement systems for standardizing the processes that are followed during development, manufacturing and quality assurance/quality control (QA/QC). Standard processes are critical for establishing efficient lab environments, fostering communication among teams, and facilitating externalization for various parts of the development and manufacturing process. Ideally, standardization should extend throughout the entire biopharmaceutical industry sector. There is a need for common ontology, vocabulary and standards for mitigating mutual challenges that all companies face.