TIDMABH
RNS Number : 0209A
Angel Biotechnology Holdings Plc
26 March 2012
26 March 2012
Angel Biotechnology Holdings plc
("Angel" or "the Company")
Company update
Angel Biotechnology Holdings plc, (AIM:ABH), the
biopharmaceutical contract manufacturer, is pleased to announce
that commissioning of the Cramlington facility is now complete as
anticipated and that the plant is now available for development,
technical transfer and other non-GMP activities.
Completion of recommissioning reflects a period of concerted
effort by all staff from across the business and our contractor
WHP. Angel intends to utilise this facility to provide additional
GMP manufacturing capabilities for the production of cell
therapies, antibody purification and production of recombinant
proteins.
By investing the additional capital, raised in the recent
placing, into the infrastructure of the facility; such as
environmental monitoring systems, utilities and superstructure,
Cramlington has been upgraded to a state of the art manufacturing
site offering three GMP cleanrooms, two Quality Control
laboratories, a fermentation pilot plant and additional flexible
development laboratory space.
Central to this progress has been the on-going recruitment of
local staff into positions in Quality, Validation and Operations
functions. This initial phase of recruitment has provided a core of
five full time key individuals who, along with staff from the
Pentlands site, will ensure the facility is fully prepared for the
Medicines and Healthcare products Regulatory Agency (MHRA) audit in
May. We will continue to focus on recruiting a further five high
calibre individuals during Q2 and Q3 this year.
Work is underway to transfer pilot processes from the Pentlands
facility as a necessary first step in securing our MHRA licences.
Data from activities is required to complete the dossier that will
be reviewed by MHRA inspectors and will ensure that the facility is
licenced in the most efficient and cost effective manner. Following
grant of a licence the facility can be used for GMP manufacturing
activities.
A first draft of the legal documents required to implement the
joint venture with Materia Medica Holdings (MMH) has completed
review. MMH have asked for changes to be made to the layout of
their dedicated GMP facility to provide greater flexibility to
introduce new programmes and new drawings have been submitted for
approval.
In addition to Cramlington activity the senior management team
is evaluating commercial opportunities currently available to
Angel. It is with this in mind that the Directors decided to take
up available funding over and above that needed to complete the
target of the January 2012 placement.
At this stage there is no guarantee any of these opportunities
will come to fruition and an update will be provided as appropriate
should they progress.
Dr Paul Harper, Executive Chairman, Angel Biotechnology
Holdings, said:
"We are delighted to be opening our Cramlington site at this
time. It is testimony to the focus and attention to detail
exhibited by the team and, in no small part, due to the support of
shareholders which enabled us to meet our time lines and make
important upgrades within the same time frame. Achieving
certification of this facility in May under our existing IMP and
MIA licences is critical to the company's long term commitment to
our customers and we are confident that we can meet this
target.
I am pleased to acknowledge the confidence shown in the Board of
the Company in making available additional funds to allow us
explore, and if appropriate to capitalise on new commercial
opportunities."
For further information:
Angel Biotechnology Holdings plc
Lorna Peers, Finance Director +44 (0) 131 445 6077
Stewart White, Commercial Director, Acting CEO
www.angelbio.com
Grant Thornton, Corporate Finance
Colin Aaronson / Melanie Frean / Elliot Berg +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 two facilities: Pentlands Science Park near Edinburgh
where it employs 38 people, and a site in Cramlington, near
Newcastle-upon-Tyne, which is expected to employ up to 10 people by
the end of 2012.
More information is available at www.angelbio.com .
Glossary
GMP Good Manufacturing Practice
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IMP Investigational Medicinal Products
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MHRA Medicines and Healthcare products Regulatory
Agency
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MIA Manufacturer's and Importer's
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- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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Angel Biotechnology (LSE:ABH)
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Angel Biotechnology (LSE:ABH)
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