Interview with Roumen Kofinov, MD, General Manager of BB-NCIPD Ltd (Bul Bio) & Özgür Tuncer, CEO & Executive Director Stablepharma Ltd
I recently interviewed Mr Roumen Kofinov, MD, General Manager of BB-NCIPD Ltd (Bul Bio) & Özgür Tuncer, CEO & Executive Director Stablepharma Ltd. The two companies have entered into a partnership to produce the world’s first fridge-free Tetanus diphtheria vaccine and have been receiving very encouraging potency and accelerated thermo-stability data from the animal challenge trials. “Our aim is to produce the world’s first fridge-free Td vaccine in partnership with Bul Bio,” added Özgür Tuncer, CEO & Executive Director Stablepharma Ltd.
During the interview, we covered such topics as the history of BB-NCIPD Ltd (Bul Bio), its success in manufacturing biological products in Bulgaria, the importance of ‘best in class staff’ and the benefits of the partnership in furthering the reality of thermo-stable vaccines.
Mr Kofinov explained that BB-NCIPD Ltd (Bul Bio) is a Bulgarian state-owned company, headed by the Ministry of Health with its origins going back as far as 1881. ‘Our GMP standard facilities export vaccines to more than 100 countries around the world, one of which is a WHO Approved liquid bacterial vaccine for diphtheria and tetanus’. Bul Bio’s portfolio consists of more than 500 products, including human blood plasma products.
“WHO projects the demand for Td combination vaccine to grow to 410 million doses by 2030”
“We are delighted to have such a strong working relationship with Bul Bio over the last few years. The Tetanus & Diphtheria containing vaccines market is expected to reach $7bn by 2027 and Bul Bio is one of the five WHO pre-qualified suppliers of the Td vaccine globally, supplying approximately 9% of demand worldwide”, said Özgür Tuncer. ‘The global demand for the Td vaccine is estimated to be around 270 million doses in 2019, and continues to grow mainly driven by WHO’s recommendation in 2015 of moving from Tetanus alone to the Td combination vaccine. WHO projects the demand to grow to 410 million doses by 2030”, added Mr Tuncer.
“The production of combined vaccines against diphtheria and tetanus in Bulgaria began in the period 1956-1958’, explained Mr Kofinov, ‘and the tetanus-containing vaccines we produce at our ‘Good Manufacturing Practice’ (GMP) site meet all regulatory standards issued by the WHO and the European Pharmacopoeia. It is important to reiterate that, much of our success as a business is due to our greatest asset – our people. Let’s be honest, maintaining standards as a state-of-the-art drug manufacturing plant is impossible without adherence to strict operational procedures. Bul Bio employs over 400 specialised staff.
“There are real benefits for UK companies doing business in Bulgaria”
The British Embassy and DIT in Bulgaria were instrumental in engineering the partnership between Stablepharma and Bul Bio, which has proven to be a great success. “There are real benefits for UK companies doing business in Bulgaria, said Dr Rob Dixon British Ambassador to Bulgaria. Highly skilled, multilingual workforce, low corporation tax (10%) and tax incentives for some investment projects have attracted prominent brands in the pharma and healthcare sector”.
“Stablepharma approached us with a non-standard and revolutionary idea to thermally stabilise the classic Tetanus and Diphtheria vaccine, explained Mr Kofinov. ‘Over the last 6 months we have been conducting a series of in-vivo challenge trials with Stablepharma’s thermostable product, StablevaX™, carried out under strict WHO protocols’. ‘The results of the trials using Td StablevaX prototypes which contain the reformulated Tetadif - TD (Bul Bio) vaccine and Tetadif - TD controls, continue to prove that a thermally stable StablevaX™ version of the standard Td vaccine, shows no deviations in potency to that of the original prototypes”, said Mr Kofinov.
Bul Bio has conducted a series of animal potency tests with suitable animal models according to EU Ph 2.7.6. and SOP-QC005. Studies have shown that StablevaX reformulation has equivalent potency to the original WHO pre-approved vaccine and StablevaX™ kept at +45°c for 2 months has equivalent potency in Tetanus and diphtheria as the refrigerated Tetadif vaccine.
"We are very excited we are one step closer to fridge-free vaccines”
“Stablepharma’s R&D team is delighted with the execution of the animal challenge potency trials being conducted in partnership with Bul Bio for Stablepharma Tetanus-Diptheria vaccine. Bul Bio are proving to be a fantastic partner and the resulting data is very encouraging, essentially validating the high-temperature stability of Td-StablevaX for prolonged periods of time without loss of potency. We are very excited we are one step closer to fridge-free vaccines”, said Arcadio Garcia de Castro, Chief Scientific Officer, Stablepharma.
“The StablevaX™ invention is the culmination of decades of work by Stablepharma founder Dr Bruce Roser, who focused on the preservation of perishable vaccines, that require constant and precise refrigeration from the factory to the patient. The WHO estimates that c 50% of all vaccines are wasted, if we can contribute to solving that problem, with the help of our partners Bul Bio, we can alleviate significant suffering and save many lives, this would be a tremendous outcome for all of us’’, commented Mr Tuncer.
Bul Bio is continuously looking to expand its portfolio of products which requires significant investment in equipment, innovation and expansion of their production facilities. The Bulgarian Government recently provided funding of EUR 11.4m to support Bul Bio with its ongoing development.
“Advances in medical innovation should be available to everyone, everywhere”
Mr Kofinov reiterated the enormous benefits of partnerships within the global Biotech sector, “this really helps address the challenges of providing a better quality of life for all societies – the gap between the rich and the poor still exists. Advances in medical innovation should be available to everyone, everywhere. This is a complex issue, one that requires long-term commitment from governments and the private sector”.
Özgür Tuncer added on partnerships, “Stablepharma is a biotech platform built on strategic partnerships with vaccine manufacturers, academia and other non-profit government entities. We were fortunate enough to add several significant partnerships recently including Bul Bio, University of Strathclyde and University of Southampton in addition to NIBSC and Innovate UK. Partnerships have got to be the way forward for better healthcare”.
“We have established a strategic R&D partnership, alongside a statement of Intention for the future development and commercialisation of the StablevaX™ Td product – this is proving to be an excellent and exciting programme for both parties,” said Dr Bruce Roser, Chairman & Co Founder.
“As British Ambassador to Bulgaria, I am very pleased that we are able to support this great collaboration between our two countries, UK and Bulgaria’, said Dr Rob Dixon, ‘the UK is a world leader in science with extensive expertise in disease outbreaks and vaccine development, while Bulgaria is no doubt one of the countries with strongest traditions in medicine and vaccine production”.
In summary, Özgür Tuncer commented, “Stablepharma is very pleased to have Bul Bio as a strategic partner along the way of launching world’s first fridge-free Td vaccine”.