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Scottish Immunotherapy Company Receives 'Specials' Regulatory Approval

Scottish Immunotherapy Company Receives 'Specials' Regulatory Approval

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TC Biopharm to work closely with hospital teams to treat patients’ unmet clinical needs


Patients not in clinical trials can now benefit from cell therapy with doctor’s guidance


Immunotherapy company TC BioPharm Ltd (TCB) has announced today that its Scottish clinical manufacturing facility has been licensed for the production of human cell therapy products under a ‘Specials’ licence.

The Specials framework is a unique EU regulatory structure which allows individual patients with specific clinical requirements to be treated with GMP-grade* products under the guidance and responsibility of their doctor.  Manufacture of products under a ‘Specials’ licence will allow TCB to work closely with clinical colleagues across the UK to treat small numbers of cancer patients who have limited therapeutic options.


Patients with a number of different cancer types may benefit from the Specials framework; Dr Rebecca Kristeleit from the UCL Cancer Institute commented:  “Treatment using novel immunotherapies may offer hope to individuals with little chance of efficacy from conventional regimes.  This approach is particularly relevant for gynaecologic malignancies, such as ovarian cancer, where access to immunotherapy treatment options are restricted and there are early signs of potentially significant clinical benefit.”

Dr Karen Williams, clinical director at TC BioPharm, said:  “Having a Specials licence allows oncologists to prescribe novel immunotherapies for individuals who are not able to join ongoing clinical trials; this is good for patients, and meets our aim of helping people with different forms of cancer.”

The Medicines Healthcare Products Regulatory Agency (MHRA) granted the ‘Specials’ licence to the Maxim Park facility at Eurocentral following an extremely positive inspection by its inspectors.  MHRA also approved the facility for ongoing GMP (*Good Manufacturing Practice) compliance, which permits the manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials.


TCB’s technology, which uses patients’ own immune cells grown in culture to target cancer, has a safe history based on the treatment of numerous patients in Japan.  Its lead product – ImmuniCell - is currently being used in a clinical study limited only to patients with lung cancer, melanoma and kidney cancer. 


TCB’s chief operating officer, Angela Scott, added:  “Staff at TCB have worked hard to realise the standards required to achieve ongoing MHRA GMP-compliance and granting of a Specials licence; moreover, we are delighted at the prospect of treating individuals under this framework, working closely with our clinical colleagues with the collective goal of improving cancer patients’ quality of life.”

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