July 1, 2009
Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients.
Comprehensive Solutions
Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that flexible partnering with our clients to meet their needs is essential for successful delivery and realizing their longer term product strategy. We underpin our partnering approach with high-quality project management and effective communication. We understand that these are essential to ensuring that our clients’ projects are delivered on time and within budget. Angel also offers management of subcontracted services such as specialist testing services and fill–finish. This is particularly popular with smaller biotechnology companies whose focus is required to be on their development pipeline.
Regulatory Compliance and Expertise
Our GMP licensed facilities in Edinburgh, UK, have a long track record of producing material for clinical use including virus. Our three (BSL-2 capable) manufacturing suites are highly flexible and can be rapidly configured to efficiently manufacture the most complex products. Angel’s UK MHRA manufacturing licenses allow the company to support all clinical trial stages and manufacture of marketed products. Angel is also accredited by the Human Tissue Authority. Angel has built extensive regulatory knowledge, particularly in the new advanced technology areas, enabling us to support our clients in a proactive way, significantly reducing their regulatory risks.
Cell Therapy
Angel is a premier supplier of manufacturing services for cell therapy IMPs, with a track record of taking these innovative products to the clinic. We offer development and GMP services for allogeneic and autologous stem cells, primary cell lines, and derivation from tissue, oncolytic, and other cell therapies. Angel has significant regulatory experience with cell therapies, potentially cutting the cost and time taken for regulatory approval. Angel offers importation services and Qualified Person release of IMPs for EU clinical trials prepared outside the European Union.
Angel has experience manufacturing short–shelf-life cell therapy products, which require release to the clinic before completion of full quality testing. We use parametric release to allow these trials to be conducted under GMP compliance. We are also experienced in managing the logistics of delivering such products to the clinic.
Bacteriophages
Angel has experience of the development and manufacture of bacteriophage (non–E. coli) for clinical trials. We offer these services up to the 50-L fermentation scale complemented with a variety of purification methods including chromatography.
Recombinant Proteins and Antibodies
Along with the successful production of recombinant proteins from bacterial and mammalian hosts, Angel has provided development and process scale-up of follow-on biologics. We have particular expertise in the GMP preparation and manufacture of hyperimmune polyclonal antibodies for clinical use in marketed products. We currently have bacterial fermentation capacity to 50L and offer mammalian production using the disposable wave system. Purification and chromatography capacity is in excess of 100 L.
Virus
Angel offers cGMP manufacture of host cells and viruses, including banking. The management team at Angel has extensive experience with a wide range of human viral vectors and host cell lines.
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