CellVec Vector Platform
For maximal biosafety, CellVec’s lentiviral vector system is based on the advanced split genome self-inactivating (SIN) packaging system. Coding sequences are codon optimised for enhanced expression and plasmid backbones are checked for alignment as part of our stringent quality control processes. CellVec’s system platform has been established to ensure compliance for current regulatory guidelines.
CellVec has established the following in-house assets and procedures to enable a fully functioning recombinant lentiviral vector contract manufacturing service to GMP standards.
CellVec’s Quality Management System complies with both European Medicines Agency and the international Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standards. CellVec is also a participant in the current WHO International Standard Panel for Lentiviral Vector Integration Copy Number Quantitation Project3, which is tasked with developing standards to ensure the safety and quality of future lentiviral-based gene therapy products.
3 NIBSC. Developing the first WHO international standard for lentiviral-based gene therapy. Available at: http://www.nibsc.org/about_us/latest_news/1st_who_is_.aspx. Accessed 11 November 2018