Biotherapeutics Development Unit

Cancer Research UK

AMC_C_FL_Cancer
AMC_C_FI_NUI_Cancer

Overview

The facility is a 2000m2 standalone unit with 300m2 of clean room. The clean rooms are segregated by 6 separate air handling units to provide suitable segregation for multi-product manufacturing campaigns. There are 2 isolators for sterile fill-finish.

Other laboratory space provides the facility for process development, scale-up and quality control testing, as well as secure cold storage of interim and final product and raw materials.

Manufacturing Capability

  • 2 independent manufacturing suites
    (Grade C with possibility to upgrade to B)
  • Mammalian cell culture up to 250L scale for protein,
    viral vector and antibody manufacture
  • Microbial culture up to 70L for protein manufacture
  • Aseptic Fill Finish up to 1000 vials per day
  • Containment Level 2 Facility

Process Capability

  • Disposable bioreactor capacity up to 250L
  • Primary recovery, capture and purification using mostly disposable systems
  • Fully validated aseptic fill finish process

Experience

  • Biologics manufacturing for Phase I and II clinical trials
  • Monoclonal antibodies
  • Recombinant Proteins
  • Viral Vectors
  • Plasmid DNA

Licenses Held

MHRA MIA IMP 21106
MHRA Specials N/A
HTA N/A

Team

Production: 5
Development/Scaleup: 6
Quality Control: 4
Quality Assurance: 3
QP: 2 (1 Contract QP)

Address

Clare Hall Laboratories,
Blanche Lane,
South Mimms,
Potters Bar,
Hertfordshire,
EN6 3LD

Contact

Heike Lentfer
Heike.Lentfer@cancer.org.uk
+44 1707625700

Location & Website

The facilities on this site took part in a survey in 2011 and have subsequently confirmed their license status.

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 angela@atmpmanufacture.org

Contact Us

If you have an inquiry send us your name, email and message.

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