Oxford Biomedica PLC MHRA approval to manufacture in new facility (6564L)
January 13 2016 - 2:00AM
UK Regulatory
TIDMOXB
RNS Number : 6564L
Oxford Biomedica PLC
13 January 2016
Oxford BioMedica Announces Successful MHRA Inspection and
Approval to Manufacture at its new Facility in Yarnton, Oxford
- New manufacturing facility fully operational
- Creates extra capacity for wholly-owned pipeline, Novartis
partnership and other new potential customers
Oxford, UK - 13 January 2016: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE: OXB), a leading gene and cell
therapy group, today announces that it has received approval from
the UK Medicines and Healthcare products Regulatory Agency (MHRA)
to manufacture bulk drug material for Investigational Medicinal
Products (IMPs) at the Group's recently established and
commissioned specialist biomanufacturing facility in Yarnton,
Oxford, UK.
The MHRA conducted a site-specific inspection in November 2015
to evaluate whether the Group's existing manufacturing processes
and quality management systems had been effectively extended and
implemented at the new Yarnton facility and remained in accordance
with EU Good Manufacturing Practice (GMP) standards. MHRA has now
confirmed that Oxford BioMedica's operations at Yarnton are in
compliance with the principles and guidelines of GMP. Consequently,
the facility at Yarnton is now fully-operational and authorised to
perform GMP manufacturing activities. The successful delivery and
licensing of the Yarnton facility provides the Group with a second
fully independent GMP manufacturing site, strengthening the
robustness of the Group's biologics supply chain, adding dual
sourcing capability and doubling capacity. This additional capacity
will support Oxford BioMedica's own proprietary programmes in
development as well as consolidating key current and potential new
strategic relationships such as the well-established CAR-T focussed
partnership with Novartis for CTL-019.
Purposely designed around the Group's current and future state
LentiVector(R) based platform processes, the 560m(2) /6,028ft(2) of
additional clean room space at Yarnton's state-of-the-art facility
bolsters the Group's manufacturing capabilities, and increases
total operational capacity across both sites to 950m(2)
/10,226ft(2) . Further capacity expansion at the Group's existing
Harrow House facility (also based in Oxford) is scheduled for
completion in the first half of 2016 and will provide a third
independent suite designed to house Oxford BioMedica's next
generation of serum free, suspension cell line based processes. The
continued investment in the Group's specialist biomanufacturing
facilities and capabilities will help Oxford BioMedica address the
industry's challenges of bridging clinical and commercial supply,
one of the main hurdles associated with the rapid progression of
gene and cell therapies through Phase II and Phase III clinical
trials, and then ultimately to market. Importantly, it also
provides the opportunity for Oxford BioMedica to maintain its
world-leading position as the LentiVector(R) platform supplier of
choice for its current and future partners.
John Dawson, Chief Executive Officer of Oxford BioMedica,
said:
"We are world leaders in the development of lentiviral
vector-based products and the successful commissioning of our
second manufacturing facility is a landmark achievement for Oxford
BioMedica. This investment brings significant potential not only to
support our own current and future pipeline of gene and cell
therapy products in development but also to support our key
collaboration with Novartis. Our IP, know-how, manufacturing
operations and capacity now position Oxford BioMedica very strongly
for securing further new partnerships and alliances."
-Ends-
For further information,
please contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive 783 000
Officer
Tim Watts, Chief Financial
Officer
Financial and corporate communications Tel: +44 (0)20 3709
enquiries: 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew
Neal/Chris Welsh/Laura Thornton
Notes for editors
About Oxford BioMedica(R)
Oxford BioMedica plc (LSE: OXB) is a leading gene and cell
therapy Group with an unrivalled portfolio of gene therapy products
in development and a platform of exclusive and pioneering
technologies with which it designs, develops and manufactures
unique gene-based medicines for some of world's largest
pharmaceutical companies. Leveraging its proprietary LentiVector(R)
IP and gene delivery system technology platform and unique tumour
antigen (5T4), Oxford BioMedica is advancing its pipeline of six
gene therapy products addressing diseases for which there are
currently no treatments or that are inadequately treated today,
including ocular and central nervous system disorders. OXB
Solutions, the Group's industry-leading manufacturing and
development business, provides services to collaborators and
partners working in gene and cell therapy, including Novartis and
Immune Design Corp. In addition, the Group has licenced products
and IP to Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich,
Biogen Idec, Emergent BioSolutions and ImaginAb. Further
information is available at www.oxfordbiomedica.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
END
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