RNS Number : 0209A
Angel Biotechnology Holdings Plc
26 March 2012
26 March 2012
Angel Biotechnology Holdings plc
("Angel" or "the Company")
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
The Communications Portfolio Ltd
Ariane Comstive / Caolan Mahon +44 (0) 20 7536 2028 / 2029
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 .
GMP Good Manufacturing Practice
IMP Investigational Medicinal Products
MHRA Medicines and Healthcare products Regulatory
MIA Manufacturer's and Importer's
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