Successful Completion of MHRA Inspection (2657E)
2012年5月29日 - 3:00PM
RNSを含む英国規制内ニュース (英語)
TIDMABH
RNS Number : 2657E
Angel Biotechnology Holdings Plc
29 May 2012
29 May 2012
Angel Biotechnology Holdings plc
("Angel" or "the Company")
Medicines and Healthcare products Regulatory Agency (MHRA)
inspection
Angel Biotechnology Holdings plc, (AIM: ABH), the
biopharmaceutical contract manufacturer, is pleased to announce
that following the recent inspection by the MHRA at the Company's
Pentlands facility, Angel has successfully retained both its
Investigational Medicinal Products licence (IMP) and its
Manufacturers' and Importers Authorisation licence (MIA). The
inspector spent two full days at the Pentlands facility, had no
critical or major observations to report and complemented the
Company's staff on being well motivated and knowledgeable.
This news comes just shortly in advance of the inspection of
Angel's Cramlington facility which is scheduled for the week
commencing 11 June 2012.
For further information:
Angel Biotechnology Holdings plc
Lorna Peers, Finance Director +44 (0) 131 445 6077
Stewart White, Acting CEO/Commercial Director
www.angelbio.com
Grant Thornton, Corporate Finance
Colin Aaronson / Melanie Frean +44 (0) 20 7383 5100
Hybridan LLP (Broker)
Claire Noyce, Deepak Reddy +44 (0) 20 7947 4350
Media enquiries:
The Communications Portfolio Ltd
Ariane Comstive / Caolan Mahon +44 (0) 20 7536 2028 / 2029
ariane.comstive@communications-portfolio.co.uk
Notes to Editors:
Angel Biotechnology Holdings plc is a full service contract
bio-manufacturing partner to biotechnology and pharmaceutical
companies worldwide. Angel specialises in advanced biologics
including biopharmaceutical proteins and cell therapies, such as
cellular vaccines and stem cells. At present, Angel's products are
principally used in pre-clinical studies and clinical trials with a
view to becoming the contract manufacturer of choice on a
continuing basis.
Drug development companies outsource their biopharmaceutical
manufacturing requirements to Angel to reduce their own capital
requirements and enable them to develop products more rapidly. In
addition, Angel provides complete regulatory services and
documentation to its customers while its manufacturing processes
adhere to the most stringent regulatory requirements. Products are
produced to current Good Manufacturing Practice (cGMP) standards as
required by the US Food and Drug Administration (FDA), and in
facilities that are certified to European standards by the
Medicines and Healthcare products Regulatory Agency (MHRA).
Its customers range from early-stage biotechnology companies
including ReNeuron plc and US-based Pathfinder Cell Therapy, to
established pharmaceutical companies such as Russian-based Materia
Medica Holdings.
Angel has three facilities: Pentlands Science Park near
Edinburgh where it employs 38 people, a site in Cramlington, near
Newcastle-upon-Tyne, which is expected to employ up to 10 people by
the end of 2012 and our new Angel Biomedical Ltd facility in
Glasgow.
More information is available at www.angelbio.com .
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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