细胞单克隆源性法规Imager成像的方法学验证-TopBiox.PDF

细胞单克隆源性法规 Imager成像的方法学验证 Name: Kun Peng 彭锟 Tel: 139 1813 0766 E-mail: kpeng@ 细胞单克隆源性法规简介：US FDA • Since~ 2011/2012 the U.S. FDA has requested information about clonality at early IND filings: “Submit data to the IND that provides assurance that this method resulted in derivation of a single cell clone or provide information on how you will go about generating these data and the timeframe for submission of the information” • ICH Q5D • For recombinant products, the cell substrate is the transfected cell containing the desired sequences, which has been cloned from a single progenitor • (US)FDA points to consider in the characterization of cell lines used to produce biologics (1993) • The MCB is defined as a collection of cells of uniform composition derived from a single tissue or cell 细胞单克隆源性法规简介：EMA • EMA/CHMP Guidance on development, production, characterization and specifications for monoclonal antibodies and related products (2008) • The cell substrate to be used for the production of the monoclonal antibodies should be a stable and continuous monoclonal cell line that has been developed by means of recombinant DNA and/or other suitable technologies • 23 June 2016, EMA/CHMP/ BWP/534898/2008 rev. 1, Committee for Medicinal Products for Human Use (CHMP) • Draft Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials • Information on the generation, qualification and storage of the cell banks is required. The MCB and/or WCB if used should be characterised and results of tests performed should be provided. Clonality of the cell banks should be addressed for mammalian cell lines. Th