Retaining in-house control of the critical stages of development of our drug products, such as GMP manufacturing and clinical operations, has allowed us to move quickly and efficiently since starting up in 2014, to being an established immunotherapy company with multiple therapeutic products in our development pipeline today.
In January 2015, TC BioPharm’s manufacturing facility was granted a Manufacturer's Authorization for Investigational Medicinal Products (MIA-IMP) which permits GMP manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials. Further to obtaining a Medicines and Healthcare products Regulatory Agency (MHRA) manufacturing license, TC BioPharm was granted a Clinical Trial Authorization (CTA) by the MHRA in September 2015 to commence clinical evaluation of autologous cell therapies built on our GDT platform. In the following years, expansion of our facility has continued including authorization for manufacture of allogeneic GDT cell products. Current capacity allows TC BioPharm to fully meet the needs of our clinical development pipeline, with trials being managed by our experienced TC BioPharm clinical team.