Oxford Biomedica PLC Manufacturing Approvals and Expansion Completed (4524F)
July 28 2016 - 2:01AM
UK Regulatory
TIDMOXB
RNS Number : 4524F
Oxford Biomedica PLC
28 July 2016
Oxford BioMedica Announces MHRA GMP Manufacturing Approvals and
Completion of Expansion Phase
- World-class centre for lentiviral gene therapy bioprocessing
and process development approved and fully operational
- Capital expenditure and expansion of Group's facilities now
complete
Oxford, UK - 28 July 2016: Oxford BioMedica plc ("Oxford
BioMedica" or the "Group") (LSE: OXB), a leading gene and cell
therapy group, today announces that it has received approvals from
the UK Medicines and Healthcare products Regulatory Agency ("MHRA")
to manufacture bulk drug material for Investigational Medicinal
Products at the Group's recently established and commissioned
second specialist bioprocessing clean room suite in Harrow House
and at its new laboratories at Windrush Court for Good
Manufacturing Practice ("GMP") analytical testing. Both
state-of-the-art facilities in Oxford are now completely developed
and fully operational.
Oxford BioMedica has established a leading platform for
lentiviral vector bioprocessing with significant know-how as well
as proprietary analytical methods based at its purpose-built
facilities which provides control over the entire lentiviral vector
manufacturing process. The Group's capabilities have resulted in
partnerships including an initial three-year contract (with
potential for extension) with Novartis under which the Group is the
sole source of lentiviral vector clinical supply for Novartis'
CTL-019 programmes and a second undisclosed CAR-T programme, as
well as being a key partner for vector manufacture process
development.
The Group has now completed all necessary expansion and related
capital expenditure requirements for its clean room and laboratory
facilities for the manufacture, analysis and release of
GMP-compliant lentiviral vector for use in clinical studies. Since
October 2014, the Group has incurred approximately GBP26 million in
expanding its bioprocessing and laboratory facilities.
The Group now has three flexible clean room suites in operation,
including the Yarnton facility which has been producing lentiviral
vector for Novartis' CTL-019 programme steadily since the site was
approved in January 2016, allowing the production of lentiviral
vectors using both adherent cell factory and 200 litre large-scale,
suspension bioreactor processes. The new second suite at Harrow
House is dedicated to serum-free, single use, bioreactor-based
production of lentiviral vector to support next-generation vector
manufacture, and will provide material to support Novartis, other
current and future partners and the Group's in-house pipeline
assets. The Windrush Court specialist laboratories include a
dedicated polymerase chain reaction suite, a suite of three
biosafety Category 3 laboratories - which are essential for the
analysis and batch release of lentiviral vectors - and laboratories
for process and product development.
Most of the Group's employees are now based at Windrush Court,
Harrow House and the Yarnton site and the Group will finally vacate
its original Medawar Centre facility by the end of October
2016.
John Dawson, Chief Executive Officer of Oxford BioMedica, said:
"The completion of the Group's capacity expansion and these key
regulatory approvals mark an important milestone for Oxford
BioMedica. The new world-class facilities have been designed to be
highly flexible so as to serve the Group and its partners well for
many years. We are now able to exploit our LentiVector(R) 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. In summary,
our world-class facilities, expertise and IP makes us an ideal
partner for the bioprocessing and production of lentiviral vector
for use in clinical studies and, in due course, commercial
supply."
-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 (LSE:OXB) is a leading gene and cell therapy
company focused on developing life changing treatments for serious
diseases. Oxford BioMedica and its subsidiaries (the "Group") have
built a sector leading lentiviral vector delivery platform
(LentiVector(R)) through which the Group develops in vivo and ex
vivo products both in-house and with partners. The Group has
created a valuable proprietary portfolio of gene and cell therapy
product candidates in the areas of oncology, ophthalmology and CNS
disorders. The Group has also entered into a number of
partnerships, including with Novartis, Sanofi, GSK, and Immune
Design, through which it has long-term economic interests in other
potential gene and cell therapy products. Oxford BioMedica is based
across several locations in Oxfordshire, UK and employs more than
230 people. Further information is available at
www.oxfordbiomedica.co.uk.
This information is provided by RNS
The company news service from the London Stock Exchange
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