Scottish medical firm awarded 'Special' licence

Scottish medical firm awarded 'Special' licence

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

Manufactures of products under a ‘special’ licence will allow TCB to work closely with clinical colleagues across the UK to treat cancer patients who have limited therapeutic options.

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. 

TCB’s technology, which uses patients’ own immune cells grown in culture to target cancer, has successfully been used for 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. 

Dr Karen Williams, clinical director at TCB 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.”

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.”