FUJIFILM Diosynth Biotechnologies has announced the launch of its new mammalian expression platform, which it has named ‘Apollo™’.
The platform is designed to create a robust ‘manufacturing-ready’ cell line and consists of four key components: a new CHO DG44-derived host cell line; a novel expression vector; a cell line development process, utilizing state of the art screening technologies and optimized media and feed components. FUJIFILM Diosynth Biotechnologies has demonstrated that this combination leads to a high producing recombinant cell line which can be used for pre-clinical material through to commercial production, and delivers titers up to 3g/L before subsequent optimization.
In addition to high productivity, Apollo™ also offers robustness and speed to clinic for customers, and can be used throughout the entire product lifecycle. Using transfectant pools, the Apollo™ platform enables supply of representative material within 10 weeks of receiving a gene sequence, and a manufacturing-ready clonal cell line in 25 weeks from transfection. The platform has low regulatory risk and uses a host cell line with proven track record.
Dr. Mark Carver, Senior VP Research, Development & Innovation, FUJIFILM Diosynth Biotechnologies said: “This is an exciting addition to our portfolio of advanced technology solutions for the manufacture of therapeutic proteins. It reflects the excellent work carried out by our team of scientists using state of the art predictive screening and high throughput approaches to create a high quality cell line development platform. We believe the platform has great potential – early media optimization indicates we can exceed 5g/L”.
He added: “This development is the latest step in the strategic expansion of our cell culture offering and builds on our 15 year track record in this space. Last year we initiated operation of our new MCC facility at our UK site, and additional 2000L bioreactors are planned to be installed at both USA and UK sites in early 2015. Our Apollo™ capability, together with these capacities, allows us to offer a ‘gene to GMP’ service for our customers”.
The Apollo™ mammalian expression platform complements the company’s pAVEway™ advanced protein expression for microbial based biopharmaceuticals. This was launched in 2007 and since then over 50 proteins have been successfully expressed using the pAVEway™ system, with the most advanced of these expected to be commercialized in the near future. FUJIFILM Diosynth Biotechnologies will continue to expand its offer as a global contract manufacturing/service provider, helping its customers to quickly deliver innovative drugs to the market and improving patients’ quality of life.