WHO Technical Report - GMP for Biological Products adopted

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

As reported in "WHO Technical Report - GMP for Biological Products Revision" in August 2015, the WHO started a revision of their TRS 822, Annex 1 "Good Manufacturing Practices for biological products; Adopted 1991. Now they published the revised and adopted new document "Annex 2 WHO good manufacturing practices for biological products". It is the replacement of Annex 1 of WHO Technical Report Series, No. 822. The new TR is supposed to give guidance to the manufacture, control and testing of biological products for human use – from starting materials
and preparations (including seed lots, cell banks and intermediates) to the finished product.

Manufacturing procedures within the scope of this document include:

Growth of strains of microorganisms and eukaryotic cells;
Extraction of substances from biological tissues, including human, animal and plant tissues, and fungi;
Recombinant DNA (rDNA) techniques;
Hybridoma techniques;
Propagation of microorganisms in embryos or animals.

This means that it covers products like allergens, antigens, vaccines, certain hormones, cytokines, monoclonal antibodies (mAbs), enzymes, animal immune sera, products of fermentation (including products derived from rDNA), biological diagnostic reagents for in vivo use and advanced therapy medicinal products (ATMPs) used for example in gene therapy and cell therapy which are manufactured by these procedures respectively processes.

For more information, please read the complete "Annex 2 WHO good manufacturing practices for biological products".