Downstream processing can be the cause of a bottleneck in manufacturing, particularly for complex biologics, leading to a need for simpler platform approaches. In this technical interview, we discuss solutions that are being deployed to address this complicated challenge and a new, more simplified approach for a diverse subset of non-mAb therapies.
In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.