A novel 'pipeline' system for downstream preparation of therapeutic monoclonal antibodies

  • Biotechnol Lett. 2013 Sep;35(9):1411-8. doi: 10.1007/s10529-013-1234-2.
Fei Wang  1 ,  Xichong Yan ,  Lina Song ,  Ping Wang ,  Di Lu ,  Jing Feng ,  Dongling Yang ,  Xiyun Yan
Affiliations
  • 1. Key Laboratory of Protein and Peptide Pharmaceutical, CAS-University of Tokyo Joint Laboratory of Structural Virology and Immunology, Institute of Biophysics, Chinese Academy of Sciences, 15 Datun Road, Beijing, 100101, China.
PMID: 23881311 DOI: 10.1007/s10529-013-1234-2
Abstract

A novel 'pipeline' system for the preparation of therapeutic monoclonal antibodies (mAb) in a non-GMP compliant environment has been developed. We used sterile silica-gel pipes to connect individual process units, in order to form a fully-enclosed and seamlessly connected system. This 'pipeline' system was used to implement downstream preparation processes for a humanized anti-CD146 mAb, huAA98, which is a therapeutic mAb generated to inhibit cancer-related angiogenesis. The quality assessment of the huAA98 end-product indicated that endotoxin levels were 0.016 EU/ml, protein A levels were 1.08 ng/ml and host cell protein (HCP) was undetectable. Thus, all measures were below the clinical criteria set by the Chinese Pharmacopoeia (Edition 2010). Having passed our proof-of-concept test, this 'pipeline' system can be used as a universal platform for the preparation of mAbs suitable for pre-clinical studies, in a non-GMP compliant laboratory environment.

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