Outsourcing Your Advanced Biologics GMP Manufacturing

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Biotech companies appreciate the challenges involved in raising sufficient investment to support their drug development pipelines. In today’s economic conditions, it is even more critical that burn rates are minimised along with risks to achieving major product development and clinical milestones.

Having reached the preclinical stage, the strategic decision whether to build in-house capability or outsource biopharmaceutical manufacturing will have been made. Limitations with investment is the main factor that will direct most companies to seek the services of a CMO (contract manufacturing organisation), and this decision should be informed by many factors including the appropriate regulatory licenses, technical know-how, track record of delivery, effective project management, and a team clearly committed to success.

About Angel Biotechnology

Angel is a UK-based CMO whose partnering approach to working with customers addresses the classic issues that face companies outsourcing manufacturing. Established in 2001, Angel provides development and CGMP manufacturing services for advanced biologics (such as cell-based products, including stem cells, bacteriophage/virus, cellular vaccines as well as recombinant proteins and hyper-immune antibodies). Located near Edinburgh, with proximity to an established network of CROs and testing houses, Angel has supported biologics development programmes for virtual through to large pharma customers.

Licenses

Angel’s two MHRA licenses (for investigational medicinal products and products for commercial sale) allow Angel to offer integrated GMP manufacturing services from early clinical trials through to commercial product. This confers a distinct advantage to clients looking to minimise the timelines, technical risk, and cost of their programme.

GMP Manufacturing

A key risk for companies with extending R&D timelines is securing GMP manufacturing slots at the right time to meet their clinical programme milestones. To satisfy market demand and ensure the maximum flexibility to accommodate the bespoke GMP manufacturing requirements of advanced biologics, Angel is extending its GMP manufacturing capability by the addition of new, multiuse GMP cleanroom suites.

Product Development

Advanced biologics present their own unique process and product definition challenges in addition to complying with the evolving regulatory requirement for their control. Angel understands the realities and challenges of the product development path and has the skills and experience necessary to expedite progress. This helps avoid the issues that frequently arise in the transfer of the production process and navigating the regulatory path to the clinic and commercial launch.

Building Partnerships

The “people” factor is an important element to be considered alongside the other key criteria for choosing a CMO. At Angel, we believe this is key to the foundation of a good working relationship and we always seek to build partnerships based on trust and a drive to achieve success for our customers.

Making the outsourcing decision for biopharmaceutical manufacturing should be influenced by additional benefits other than cost alone. Angel’s comprehensive service offering confers this added value, within a competitive pricing structure, thus ensuring the best overall return on investment.

About the Author

Author Details
Dr. Finn Willingham is director or business development Pentlands Science Park, Edinburgh, EH26 OPZ, 44-7939-588941 or 44-131-445 6077; finnwillingham@angelbio.com; www.angelbio.com.

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