title: A novel 'pipeline' system for downstream preparation of therapeutic monoclonal antibodies.
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.
authors.affiliation: 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.
authors.forename: Fei
authors.initials: F
authors.lastname: Wang
authors.forename: Xichong
authors.initials: X
authors.lastname: Yan
authors.forename: Lina
authors.initials: L
authors.lastname: Song
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.forename: Di
authors.initials: D
authors.lastname: Lu
authors.forename: Jing
authors.initials: J
authors.lastname: Feng
authors.forename: Dongling
authors.initials: D
authors.lastname: Yang
authors.forename: Xiyun
authors.initials: X
authors.lastname: Yan
mesh_terms: D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D001688:Biological Products / Q000302:isolation & purification*; D001709:Biotechnology / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004731:Endotoxins / Q000032:analysis; D013205:Staphylococcal Protein A / Q000032:analysis; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D004731:Endotoxins; D013205:Staphylococcal Protein A