Successful Completion of MHRA Inspection (9989F)
June 25 2012 - 2:00AM
UK Regulatory
TIDMABH
RNS Number : 9989F
Angel Biotechnology Holdings Plc
25 June 2012
25 June 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 the inspection in early June of our Cramlington site, by the
MHRA, was completed successfully. The inspector spent three days at
our facility and raised no critical or major observations. Critical
and/or major observations is the terminology used by the inspector
to define shortcomings that usually require remedial action before
a license can be granted. The first inspection of what is
effectively a new facility is the most challenging and it is a
credit to the Angel team that Cramlington met the standard required
to be added to Angel's GMP license.
Dr Paul Harper, ABH Chairman said: "This is a significant
achievement for the company and opens the way to expand our
business by being able to offer GMP capacity suitable to
accommodate larger programmes. This has been achieved whilst
maintaining our existing business activities and undertaking the
integration of Angel Biomedical Ltd as a new Group company. The
Board of Directors wish to commend the team for an exemplary
performance."
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 specializes 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 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
MSCEALKAALSAEFF
Angel Biotechnology (LSE:ABH)
Historical Stock Chart
From Apr 2024 to May 2024
Angel Biotechnology (LSE:ABH)
Historical Stock Chart
From May 2023 to May 2024
