Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56

In this episode of PharmTech’s Pharma Fundamentals, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates and a member of PharmTech’s editorial advisory board, and Amnon Eylath, president and founder of Broad Spectrum GXP, discuss biologics development, the quality system, and the Parenteral Drug Association’s (PDA) revision to Technical Report No. 56 (TR56),¹ which Eylath is a co-author on.

Link to the Video and Article on Pharmaceutical Technology

Applying Phase-Appropriate Quality Systems to Biologics Manufacturing

Developing biologics requires a quality system that accounts for the unique challenges of working with living cells, complex manufacturing processes, and contamination risks. The Parenteral Drug Association’s (PDA) Technical Report 56 (TR56), Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance, provides guidance on scaling quality requirements throughout development.

This article explores how quality systems for biologics differ from those for small-molecule drugs, with particular emphasis on microbiological controls, containment, process sensitivity, and time-critical manufacturing decisions. Biologics often require more rigorous bioburden monitoring, environmental controls, and rapid, science-based investigations to address deviations before product quality is compromised.

The discussion also highlights the importance of container closure compatibility, extractables and leachables testing, risk assessment, and knowledge transfer throughout development and scale-up. While the underlying quality system framework is similar for both biologics and small molecules, biologics require specialized controls tailored to their unique characteristics.

By implementing phase-appropriate quality systems and addressing these challenges early, manufacturers can better manage development risks, maintain product quality, and support successful biologics manufacturing.

Read the full article:
Applying Phase-Appropriate Quality Systems to Biologics Manufacturing