ASIT biotech, a clinical stage biopharmaceutical company focused breakthrough allergy immunotherapy products, received Good Manufacturing Practices (GMP) certification for its manufacturing site in Liège, Belgium, from the Federal Agency for Medicines and Health Products (FAMHP).
 
The certification follows a 2-day site inspection and constructive dialogue with the Agency. It allows ASIT biotech to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies (gp-ASIT+TM) under GMP-compliant conditions for future clinical and commercial use.

Further to the site certification, ASIT biotech is preparing the production of gp-ASIT+TM active pharmaceutical ingredient validation batches to support anticipated regulatory filings in 2020, pending the positive outcome of the ongoing Phase III trial.

Michel Baijot, chief executive officer of ASIT biotech, said, “The GMP certification is the result of an outstanding team effort and is part of the industrial strategy initiated at the beginning of the year with the new management. We want the ability to control the entire value chain associated with the ASIT+ TM technology platform for gp-ASIT+™ active pharmaceutical ingredient as well as for other future immunotherapy product candidates we have in the pipeline. Internalization of our manufacturing process within 8 months with GMP certification at the end reflects the capacity of our organization to stay focused, to execute and to deliver in due time. I am very proud of the team, and I am confident in our capacity to continue the transformation of ASIT biotech in a development and marketing organization focused on bringing innovative therapies to patients suffering from allergies.”