Biotherapeutics Development Unit

The Biotherapeutics Development Unit (BDU) is a bio-manufacturing facility that is dedicated to process development and cGMP manufacture of novel biological therapeutics for clinical trials.

The unit has been producing biological therapeutics for use in early phase clinical trials since 1990 and has been involved in the development of 22 different monoclonal antibodies and nine DNA vaccines for research and development, as well as early phase clinical trials.

From 2010 the BDU has been operating from a new purpose built and MHRA licensed facility with a team of highly skilled scientists, who can offer expertise in developing robust manufacturing processes whilst ensuring full regulatory compliance.

The facility offers manufacturing solutions through to final fill/finish and release of product for clinical trials. State of the art manufacturing equipment enables us to develop processes that are scalable and transferable for potential further manufacturing needs if a product is licensed to pharmaceutical partners.

What the BDU offers:

• GMP Cell Banking
• GMP Manufacture of Virus Seed Stocks
• Process Development and Scale-up Expertise
• Assay Development Expertise
• cGMP Manufacture of Biologics
• Formulation and Aseptic Filling (1000 vials / day)

The BDU is committed to delivering efficient, robust and safe manufacturing solutions that enable us to bring new drugs into the clinic in a faster and more cost effective manner.

BDU capabilities:

• We have state of the art equipment
• We take on challenging and complex processes
• We ensure the highest quality standard for maximum patient benefit and safety

For further information on the Biotherapeutics Development Unit and its capacity please contact Heike Lentfer at heike.lentfer@cancer.org.uk.