Cellular Therapeutics Ltd

GMP Certified Unit

AMC_C_FL_CellTher
AMC_C_FI_CellTher

Overview

Our facility (a Good Manufacturing Practice (GMP) certified Unit) is a flexible space allowing us to manufacture cell therapies (with or without gene modification) for clinical trials or as Manufacturing Specials.
Alongside eXmoor Pharmaceuticals we have designed and built a bespoke manufacturing facility specifically for our needs. Our current set-up gives the flexibility of allowing up to 6 products to be manufactured simultaneously with up to 4 open processes at any one time. The facility is also designed to allow rapid expansion to increase capacity within our current space, without the need for expensive new clean rooms.

The growing field of medicine, termed Advanced Therapy Medicinal Products (ATMPs), heralds a new era in patient care and treatment. These ATMPs are used to treat major indications that are currently unmet by standard of care. Our facility is ideally suited to aid the development of these therapies by providing an experienced team within a state of the art facility.

Manufacturing Capability

  • CTL holds MHRA Authorisation for manufacture of Investigational Medicinal Products (IMP)
    and Manufacturing Specials (MS)
  • We have independent Grade D suite (75m2) with 3 Grade A 4-glove isolators. Fully equipped for closed processing
  • We have Liquid Nitrogen Cell Storage
  • Support rooms
  • Category 2 biological containment
  • Separate GMP assays suite
  • QM, QA, QP supported with experienced production staff
  • Separate R&D and process development suite

Process Capability

  • Custom Manufacturing Organisation (CMO)
  • Process transfer & Development
  • Adherent cells
  • Suspension cells
  • T cells, TIL
  • Tissue processing
  • Gene modified cells
  • Patient/Autologous specific processes
  • Bulk allogeneic processes

Experience

Our experience is primarily around closed and open processing of cells in suspension including: Natural T cells (TIL for melanoma), CAR & TCR modified T cells. Our team has experience of working within classical clean rooms, and of working in our currentl facility using “clean room free technology” such as Grade A isolators and closed systems within a Grade D suite.

CTL’s production team has come out of the research group of Professor Robert Hawkins, a leader in the field of Cellular Therapy of Cancer, and has successfully provided cell products for several complex products involving: cell selection, gene therapy, expansion of patient derived cells. To date our team has produced many autologous cell therapies for several clinical trials over the past 10 years (including natural T cells, TCR modified T cells and CAR modified T cells).

CTL also has a wealth of experience in working closely with many organisations to facilitate delivery of cell therapies including: the MHRA, the HTA, trial sponsors, surgical units, clinicians, clinical support teams, pathology departments and academic institutions.

Licenses Held

MHRA MIA Investigational Medicinal Product (IMP) &
Manufacturing Special (MS) Authorisation: # 44168
HTA Human Application Licence: TBC

Team

CEO: Prof Robert Hawkins
COO: Nicola Price
Director of Production/Quality Manager: Dr Ryan Guest
Production Manager: Natalia Kirillova
Experienced Production Scientists
QP: Gillian Lewis

Address

Cellular Therapeutics Ltd,
48 Grafton Street,
Manchester,
M13 9XX,
UK

Contact

Nicola Price
info@cellulartherapeutics.co.uk
+44 (0)161 603 7732

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.