Invitrogen Introduces Innovation that Speeds Regulatory Filings and Time-to-Market for Biotherapeutics Manufacturers

Invitrogen, a division of Life Technologies, today announced the launch of the GIBCO® OptiCHO™ Protein Express Kit, a new integrated solution for simple and efficient serum-free development of stable cell lines for biotherapeutic development. This is the first kit of its kind to provide cells banked under cGMP conditions, enabling biotherapeutics manufacturers to speed regulatory submissions and time-to-market.

The GIBCO OptiCHO Protein Express Kit enables biotherapeutics manufacturers to develop stable cell lines where proteins of therapeutic interest can be expressed and reproduced. It incorporates all of the reagents, protocols and documentation required to go from gene to stable cell clones expressing the protein of interest within a completely serum-free process. All of the products within the workflow are animal-origin free, which supports biomanufacturers’ ability to enhance the safety of human therapeutics.

The OptiCHO kit is available for research use; however, laboratories interested in pursuing regulatory filings and are in need of a documentation package, can purchase a commercial use license for a one-time fee, with no maintenance costs or royalties required. This is unlike other stable cell line development systems that require expensive research and commercial use licenses, royalties and maintenance fees.

“As the regulatory climate for biotherapeutics continues to tighten, we are providing our customers a competitive advantage with improved product safety controls and cGMP documentation to support the development of therapeutic proteins in stable cell lines,” said Christopher Linthwaite, Vice President of Invitrogen Bioproduction for Life Technologies’ Cell Systems Division. “The OptiCHO Protein Express Kit provides a complete solution for efficient and cost-effective stable cell line development, while providing documentation to support faster regulatory filings and commercialisation.”

The OptiCHO Protein Expression Kit can be used as part of a complete workflow for stable cell line development that can be enhanced with use of the Countess™ Automated Cell Counter to simplify the cell counting steps of the protocol. Optimised components within the kit, such as TOPO® TA Cloning® Kits enable faster, more efficient creation of vectors and FreeStyle™ MAX Transfection Reagents provide highly efficient, animal origin-free lipid transfection.

Invitrogen is a leading provider of platform independent, essential life science technologies for disease and drug research, bioproduction and diagnostics. Invitrogen, together with Applied Biosystems – a global leader in providing innovative instrument systems to accelerate academic and clinical research, drug discovery and development, pathogen detection and forensic DNA analysis – is part of Life Technologies Corporation, which markets the life science industry's most comprehensive portfolio of solutions for molecular and cell biology. Invitrogen and Applied Biosystems products are used in nearly every major laboratory in the world.