How to Avoid Last Minute CMC Roadblocks to Approval

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.

The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.

In this case study, Colbert shares the methodology behind its robotic implementation, from defining the scope through vendor selection, design considerations and project wins.

An Overview of RFID Technology for Retail and Healthcare Packaging