OREANDA-NEWS. A new case study on how we helped FUJIFILM Diosynth Biotechnologies (Fujifilm) future-proof a mammalian cell culture manufacturing facility in Billingham, UK, is out now.

The process for the manufacture of this cell culture is the basis for developing and manufacturing monoclonal antibodies as well as other biotechnology products that tackle illnesses such as cancer and heart conditions.

Fujifilm involved MHRA early on to meet regulatory expectations to reduce risk of any late or costly changes. They wanted to include as much feedback from MHRA into the design of the facility as possible.

MHRA’s Inspectorate Group Manager, Mark Birse said:

Innovation of the kind Fujifilm has delivered is crucial in ensuring the medicines of tomorrow are developed quickly and cost-efficiently. Our open and pragmatic approach to regulation is designed to support organisations achieve high standards: in site development; in drug manufacture; in public health and patient safety.