Pharma Fundamentals: Biologics Quality System

In this episode of PharmTech’s Pharma Fundamentals, Susan Schniepp, distinguished fellow with Nelson Labs 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.

Why a Separate Framework Was Needed

The PDA’s TR56, Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance, was written in response to a practical problem: companies were applying full commercial-scale quality standards to early-phase clinical products, which wasn’t working. Certain systems simply cannot and should not, according to Eylath, be in place during early development. The report, now in its third version, provides guidance on scaling quality requirements appropriately across development phases. The report’s core principles apply broadly across both biologics and small molecules; however, the differences between its application to biologics compared with small molecules lie in complexity and in the relative level of containment and contamination control required. In addition, FDA requested that TR 56 (2012) also serve as a guide to best practices for smaller and academic biologic manufacturers who may not have the level of experience to understand what must be in place throughout the development of a biological drug substance.

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Reference

Brewer RA, Eylath AA, Kirschbaum N, et al. Technical Report No. 56 (Revised 2026): Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance. PDA. February 2026. https://www.pda.org/bookstore/product-detail/8742-technical-report-no-56-revised-2026

About the Speaker

Amnon Eylath is founder of Broad Spectrum GXP, which provides strategic consulting, operational services, and interim leadership, empowering organizations to close gaps, mitigate risks, and to achieve a state of inspection readiness and operational excellence. Committed to developing high-performing teams.

Eylath is past president of the New England PDA chapter. International thought-leader on Phase-Appropriate application of cGMP to biological drug and ATMP development and manufacturing, working in collaboration with FDA, MHRA and EMA. Collaborated with FDA on sterilization and aseptic processing technology education.