Release Protocol for Crucell rMCB A068-016 The QC testing was conducted by contract at Inveresk Research (Tranent, Scotland) and at MicroSafe (Leiden, The Netherlands). The release protocol to ensure the (i) identity, (ii) sterility, and (iii) viral safety of the rMCB is presented in Table II. The development of PER.C6 research master cell bank (rMCB) A068-016 to support manufacture of biologies has been previously described. QC Testing for the Release of PER.C6 Master Cell Bank The general methods of testing to ensure product safety are presented in illustrated form in Fig. More recently, with the development of exquisitely sensitive polymerase chain reaction (PCR) methods for the detection of agents which are refractory to animal or cell culture, these classical propagation methods are commonly supplemented with agent-specific testing, using PCR and polymerase-enhanced reverse transcriptase (PERT) assays. These methods are well known to be sensitive to the detection of a variety of bacterial and viral agents and applied in concert provide a comprehensive and sensitive analytical approach upon which to ensure product safety. The release protocol specifies testing methods and volumes to be tested relying upon bacterial broth and agar cultures, embryonated eggs, small animals, and in vitro cell culture in a variety of primary and continuous cell lines of mammalian or human origin. The release protocol prescribes the QC testing to be applied not only to final product but, importantly, master cell banks, master virus seeds, and other bioprocess inputs, raw materials of animal origin, and intermediate bulk products developed during downstream processing, purification and formulation. The release protocol is developed through an evaluation and integration of (i) relevant compendial literature and precedents, (ii) the origin of the cell line used for production and its development as a master cell bank, (iii) the sourcing and quality control testing of raw materials of animal origin used in manufacture, and (iv) the method of good manufacturing practice (cGMP) manufacture of the bulk and intermediate and final product considering, among other things, the quality of environment in which bioprocessing is conducted, the method of manufacture, in particular the isolation of the culture system from operators, and the consistency of preparation. The program for QC testing applied to a biological product, formalized as a release protocol, is developed as a responsibility of a Department of BioAnalytical Development. This QC testing is intended to (i) ensure the identity of the product, (ii) ensure the safety and sterility of the product by demonstrating the absence of adventitious microbial agents, and (iii) ensure the safety and sterility of the product by demonstrating the absence of adventitious viral agents. The safety of vaccines and biologicals manufactured in continuous cell lines of animal or human origin is of paramount importance and must be ensured by the manufacturer through a program of quality control (QC) testing applied to the product before release for human administration. QC Testing of PER.C6 Cells for Use in the Manufacture of Biologicals and Vaccines
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