Both the facility itself and the equipment are being validated in anticipation of full operations starting in late 2021; the company said the site is ready to start manufacturing qualification batches for customers to ensure it is ready to begin commercial production.
Rapid delivery, local supply chains
As well as increasing the production capacity of cell culture media products, the site is a vital hub for European markets; it offers more local supply, and savings on shipping costs.
Weighing in on that, Kevin Kolell, director of strategic marketing, Fujifilm Irvine Scientific, told BioPharma-Reporter:
"Cell culture media is a critical raw material for biologics and we saw a need to provide easier, more cost-effective access to biopharmaceutical, vaccine, cell and gene therapy markets.
"Reliable, rapid, cost-effective delivery is critical to our customers. The disruptions caused by the COVID-19 pandemic have forced companies around the world to examine their raw material supply chain. With the new manufacturing facility in Tilburg, our European customers will have the media they need produced locally and easily obtainable through ground transport. This also reduces time and cost of delivery compared to shipping overseas. The reduction of cost will be most significant for bulk liquids.
"Building a local manufacturing facility offers redundancy in the supply chain that helps to ensure continuity, as well as enables us to provide customers with faster response times and increased flexibility for a wide variety of production timelines and product needs."
And, despite challenges to supply chain and operations caused by the pandemic, the company reported that the delivery of essential equipment and construction of the new Tilburg facility progressed throughout 2020.
The facility will follow current good manufacturing practice (cGMP) and will manufacture dry powder media, liquid media, buffers, and Water for Injection (WFI) as per quality system, raw materials, and expertise used in its facilities in the US and Japan.
Production capacity
With production capacity in the range of 320,000 kg per year of dry powder media and 470,000L per year of liquids, the Tilburg site has the capability to expand rapidly, added Fujifilm.
The facility is also set to work towards a CO2-neutral status, using wind energy for the production process, and using sustainable technologies such as membrane bioreactors for wastewater purification, in keeping with the Fujifilm group’s sustainability goals up to 2030.