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- Title
A novel 'pipeline' system for downstream preparation of therapeutic monoclonal antibodies.
- Authors
Wang, Fei; Yan, Xichong; Song, Lina; Wang, Ping; Lu, Di; Feng, Jing; Yang, Dongling; Yan, Xiyun
- 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.
- Subjects
MONOCLONAL antibodies; NEOVASCULARIZATION; IMMUNOGLOBULINS; ANTIBODY diversity; BACTERIAL immunoglobulin-binding proteins
- Publication
Biotechnology Letters, 2013, Vol 35, Issue 9, p1411
- ISSN
0141-5492
- Publication type
Article
- DOI
10.1007/s10529-013-1234-2