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.
Advanced LC-MS Technology for Enhanced HCP Detection in Complex Biotherapeutics
February 26th 2025The 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.