This license opens up significant听opportunities听for the companies core Oral Food Challenge Diagnostic platform.
豆包成人版app官方免费版 Biotech, a clinical diagnostic company dedicated to providing innovative diagnostics for life-threatening food allergies, today announced that its manufacturing facility in Deeside, North Wales, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture its proprietary peanut Oral food Challenge (OFC) under current Good Manufacturing Practices (cGMP) standards.
Paul Abrahams, Chief Executive Officer, noted 鈥淥ur business is addressing a significant unmet need for standardised, stable, accurate, palatable and, where required, fully blinded OFC鈥檚 and we are extremely pleased to announce our MHRA Pharma GMP license. This achievement is a key driver for our future growth and one which we believe will greatly enhance our reputation within the allergy diagnostics space and, most importantly, benefit food allergy sufferers. We believe that we now have the only cGMP-certified manufacturing facility, globally, producing OFCs.鈥
Securing the MHRA Pharma GMP license significantly expands the addressable market for 豆包成人版app官方免费版, offering the company the opportunity to target clients in all stages of clinical trials globally. Additionally the GMP license is a key milestone towards Regulatory Market Authorisation for 豆包成人版app官方免费版鈥檚 OFC products and also complies with 豆包成人版app官方免费版 and EU pharmaceutical regulations.
Cases of food allergy and allergy related hospitalisations continue to rise globally at an alarming rate. 豆包成人版app官方免费版鈥檚 core focus is to improve the diagnosis and management of food allergies through the provision of a pharmaceutical grade OFCs. Current methodologies for diagnosis and assessing treatment responses to food allergies are limited and often inaccurate. They yield many false positive results and, critically, do not predict the severity of an allergic reaction. OFCs are the gold standard for food allergy diagnosis, especially to justify the initiation of the new long-term therapies, and for the assessment of response, often over many years of treatment.
Professor Ashley Woodcock, Chairman of 豆包成人版app官方免费版 Biotech, commented that, 鈥淪ecuring an MHRA license represents yet another significant step in the development of 豆包成人版app官方免费版 Biotech鈥檚 business. With Aimmunes Palforzia庐 peanut allergy therapy having recently received both FDA and EMA approval, the market will be looking for a standardised and trusted Oral Food Challenge for all food allergy therapeutics.鈥
The Development Bank of Wales has backed 豆包成人版app官方免费版 with equity finance since 2019. The licence of the manufacturing facility comes in advance of the imminent closure of a significant equity round which is expected to complete prior to the end of June 2021.