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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Acknowledgments
This study is partly supported by the National High-tech R&D Program of China (863 program) (2012AA02A304), the National Science and Technology Major Project (2013ZX10002-009-014, 2013ZX10004102).
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Wang, F., Yan, X., Song, L. et al. A novel ‘pipeline’ system for downstream preparation of therapeutic monoclonal antibodies. Biotechnol Lett 35, 1411–1418 (2013). https://doi.org/10.1007/s10529-013-1234-2
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DOI: https://doi.org/10.1007/s10529-013-1234-2