26 March 2012 <\/p>\n
Angel Biotechnology Holdings plc <\/p>\n
(\"Angel\" or \"the Company\") <\/p>\n
Company update <\/p>\n
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 (KOSDAQ: 018290.KQ - news) activities. <\/p>\n
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. <\/p>\n
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. <\/p>\n
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 (Xetra: 938858 - news) 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. <\/p>\n
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. <\/p>\n
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. <\/p>\n<\/p>\n
See the article here: 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 (KOSDAQ: 018290.KQ - news) 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. Continue reading
\nAngel Biotechnology - Update on Cramlington<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"