FUJIFILM Diosynth Biotechnologies, a leading global biologics Contract Development and Manufacturing Organization (CDMO), has announced that it is in the process of establishing a long-term collaboration with MSD, a global biopharmaceutical company known as Merck in the U.S. and Canada, to invest in and operate a large-scale microbial-biologics facility for supply of active pharmaceutical ingredient (API) to its customers.
This collaboration involves a $60-million USD investment by MSD at its Brinny manufacturing plant in Innishannon, County Cork, Ireland. MSD in Brinny has been in operation for more than 30 years and is an integrated site for the development, testing and manufacturing of biologics.
It is intended that the large-scale biologics operations at MSD in Brinny will be operational in early 2018 for biotech and pharma customers of Fujifilm Diosynth.
• Addresses a market need for large-scale microbial biologics manufacturing;
• Complements Fujifilm Diosynth’s existing microbial capacity that ranges from 100L up to 5000L both in the USA and UK; and
• Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations.
Fujifilm Diosynth will lead customer interactions, program management and process and analytical development, and the MSD facility in Brinny will operate as cGMP manufacturing support for Fujifilm Diosynth’s CDMO business, enabling seamless technology transfer and technical support.
Microbial fermentation remains vital technology for the process of manufacturing biologics, and this investment, drawing on the latest production advances, will enable Fujifilm Diosynth’s existing and future customers to have a clear and secure line-of-sight to higher product volumes along with lower cost-of-goods. The latter is particularly important as products enter late clinical phase and commercialization.
Steve Bagshaw, CEO of Fujifilm Diosynth, said “We are delighted to progress this collaboration which illustrates how innovative approaches bridging pharma and CDMO can build value for suppliers and ultimately patients.”
Sanat Chattopadhyay, president of the MSD Manufacturing Division, said: “MSD is excited to collaborate with Fujifilm Diosynth through expanded capabilities in bulk microbial fermentation and downstream support services. This will allow MSD to use and further develop the skills and competencies of the people at the MSD site in Brinny and build on the site’s long tradition of manufacturing excellence.”