We're crowdfunding! Own a part of our business. Capital at Risk.
View our pitch

Stablepharma achieve significant milestone in the GMP manufacture of a fridge-free Td vaccine

Stablepharma Ltd in collaboration with their leading global CDMO partner have achieved a significant milestone in the GMP manufacture of their lead candidate, fridge-free Tetanus Diphtheria vaccine (SPVX02), based on StablevaX™ technology.

Stablepharma have reported the successful manufacture and analytical testing of over 10,000 vials (doses) of SPVX02 under GMP conditions, in Monza, Italy and the subsequent submission and approval of a manufacturing license by AIFA (Italian Regulatory Agency).

The receipt of the manufacturing licence aligns Stablepharma to submit a Clinical Trial Application (CTA) to the MHRA (UK Regulatory Agency), giving further confidence that the first-in-human clinical trial led by Professor Saul Faust OBE, at the NHS University Hospital of Southampton, and Dr Karen O’Hanlon, Chief Development Officer of Stablepharma, will likely commence later this year.

“Successfully manufacturing and testing of 10,000 doses of SPVX02 under GMP conditions is an important step towards launching, what could be, the world’s first fridge-free Tetanus diphtheria vaccine (SPVX02), said Özgür Tuncer, CEO & Executive Director, Stablepharma Ltd. ‘Furthermore, we have now demonstrated that our StablevaX™ technology can be manufactured under scalable GMP conditions, enabling us to scale-up the manufacturing process to provide millions of doses per year”.

Stablepharma have demonstrated that SPVX02 can endure temperature fluctuations in ongoing SPVX02 stability studies. SPVX02 data aligns with previous StablevaX™ stability data, and confirms the robustness of SPVX02 in maintaining efficacy under challenging environmental conditions, where the vaccine was exposed to cycles of temperature which varied from -20°C to +40°C. This finding is significant as it will eliminate the necessity for cold-chain transportation, simplifies logistics and reduces vaccine wastage. 50% of vaccines are wasted annually due to failures in the cold chain, according to the WHO.

Dr Karen O’Hanlon, Chief Development Officer, Stablepharma, said, “We have developed and designed a manufacturing process which has resulted in the production of 10,000 sterile single-dose vials of SPVX02 under GMP conditions. In addition, we have also completed formal freeze-thaw stability studies on this batch of SPVX02, and have successfully demonstrated that the vaccine remains stable, and fully potent, after 3 cycles of temperature fluctuation from -20°C to +40°C. We are delighted with these outcomes which clearly highlight the robustness of our StablevaX™ technology and provides yet further evidence of its unique ability to thermostabilise vaccines”.

“The establishment of a GMP manufacturing process that provides a thermostable formulation for SPVX02 represents a major inflection point for Stablepharma as it transitions to a clinical stage company”, said Dr Steven Chatfield, Stablepharma Advisory Board Member.

“We are rapidly progressing towards achieving our vision of making fridge-free vaccines a reality, which in effect means eliminating the requirement for temperature-controlled shipments of our fridge-free vaccine, SPVX02”, added Ozgur Tuncer.