Clinical Biotechnology Centre

NHS Blood and Transplant

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Overview

Clinical Biotechnology Centre (CBC) is an experienced, UK-based, CDMO providing services of the highest quality at affordable prices.  Our aim is to be your preferred provider of quality-assured plasmids, viral vectors, and gene therapy therapeutics.  As part of NHS Blood and Transplant’s (NHSBT’s) Cellular and Molecular Therapies (CMT) function, we have over 20 years of experience manufacturing to GMP, under an MHRA IMP licence, and receive routine audits from our internal audit programme, customers and regulator.  An ambition to drive innovation and collaborate with partners is central to NHSBT’s longer-term strategy.  The commitment to develop and scale services within the gene therapies field is assured and also demonstrated through significant investment in manufacturing facilities.  We work with healthcare, academic, and commercial customers worldwide.  We are your ‘one-stop-shop’ for gene therapy products.

Capabilities

CBC offers:

  • MHRA IMP licence and full GMP compliance
  • Multiple segregated clean rooms for processing and final fill
  • Over 20 years’ GMP manufacturing experience
  • GMP manufacture of plasmids, lentiviral and AAV vectors
  • Quality control testing
  • Importation of investigational medicinal products into GB
  • Process and assay development
  • Advice on manufacture and quality control
  • Quality assurance and QP release

As part of the NHS, we provide a reliable service on a cost recovery basis, so our prices are affordable.  We also benefit from the resilience of a national infrastructure, so our customers can be confident that they’ll have a stable, reliable partner committed to a long-term collaboration.  We aim to support partners in progressing their gene therapies through clinical trials to ultimately, increase patient access to novel lifesaving therapies.

We have supported numerous clinical trials, treating patients around the world for a broad range of infectious, malignant or inherited disorders including (but not limited to): age-related macular degeneration (AMD), renal cell carcinoma, B-lineage acute lymphoblastic leukaemia, haemophilia, HIV and cystic fibrosis.  With a wealth of expertise and experience, we manufacture products for a variety of research, pre-clinical and clinical campaigns, for academic and commercial partners.  We have the experience to de-risk your project plans, and the know-how to overcome the challenges of transferring manufacturing processes to GMP compliance.

Facilities

  • Custom designed GMP facility covering 940m2 of space over two floors
  • Flexibility to manufacture different product types
  • Total of 10 clean rooms for spatially and campaign segregated manufacture using single-use disposables and with a dedicated Fill & Finish room
  • Capacity to manufacture GMP-grade plasmids in parallel
  • Dedicated laboratories equipped to undertake pre-GMP manufacture, process development, and QC testing

Why choose us?

  • 20 years’ experience manufacturing GMP-plasmids
  • UK-based, providing regulatory and logistical advantages
  • Extensive experience supporting partners worldwide
  • Charge on a cost recovery basis at affordable prices
  • Flexible, collaborative, and approachable team
  • Bespoke service offered to meet your individual needs
  • Guidance on translating your products to clinic
  • Support for academics and early-stage therapies

Licenses Held

MHRA MIA IMP 25224
HTA 22518

Team

Production: Dr Paul Lloyd-Evans
Production Supervisor: Denise Phillips
Quality: Adam Ziegler
QP: Keith Smith

Address

Clinical Biotechnology Centre
NHS Blood and Transplant
500 North Bristol Park
Filton
Bristol
BS34 7QH

T: 0117 921 7215

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Location & Website

Updated October 2023

If you are the manager of a facility licensed for ATMP manufacture in the UK, not included on this site and would like it to be please email admin@atmpmanufacture.org