Oxford BioMedica secures UK MHRA approval to manufacture drugs at new facilities

The gene and cell therapy group recently established and commissioned a second specialist bioprocessing clean room suite at Harrow House and at its new laboratories at Windrush Court for analytical testing.

Both sites, in Oxford, are now completely developed and fully operational.

The company will fully vacate its original Medawar Centre facility by the end of October.

This is the group’s third approval after its Yarnton facility was approved in January 2016 where it continues to produce lentiviral vector for one of its partners.

The gene and cell therapy group headquartered in Oxford will now go ahead with production of lentiviral gene therapy medicines at its newly established bioprocessing clean room suite at Harrow House.

Its laboratories located at Windrush Court which received the Good Manufacturing Practice (“GMP”) analytical testing approval will facilitate analysis and batch release of lentiviral vectors.

Oxford BioMedica CEO John Dawson regarded the MHRA GMP approvals as an important milestone for the company.

He also said: “We are now able to exploit our LentiVector platform to its full potential and we are excited by the progress we have made in developing a 200 litre serum-free suspension production process which allows significantly larger volumes of vector to be produced at significantly lower cost per patient dose.”

Focused on developing life changing treatments for serious diseases, the company designs, develops and produces gene and cell-based medicines that are capable of delivering therapeutic DNA into patients’ cells.

So far, Oxford BioMedica has come up with a portfolio of gene and cell therapy products that cover the areas of oncology, ophthalmology and central nervous system disorders.

The company also has several partnerships, including with Novartis, Sanofi, GSK, and Immune Design.