ASIT Biotech Adds GMP Manufacturing Unit

ASIT biotech has installed and qualified a clean room with the equipment to produce, in compliance with GMP requirements, the API for the Phase I/II studies in house dust mite and peanut allergies treatment.  

The availability of a dedicated GMP manufacturing unit reduces the technology transfer duration and improves the flexibility and the agility of such transfer from the R&D to production thanks to the "real-time" fine-tuning opportunities. It also lifts the constraints related to third party CMO capacity scheduling and secures manufacturing as well as the overall development planning.  ASIT biotech expects the grant of the GMP certification by the Belgian Regulatory Authorities, as well as the release of the first clinical batch of pnt-ASIT+™ for the first-in-man study in peanut allergy, in H1 2019.   

Thierry Legon, chief executive officer of ASIT biotech, said, "The establishing of our own GMP manufacturing unit is key for the development of all our allergy-immunotherapy programs, especially in food allergies where we aim to submit the first clinical trial authorization for pnt-ASIT+™ in peanut allergy as early as the end of H1 2019. We then plan to immediately seek a clinical trial application for hdm ASIT+™ in house dust mite allergy.  Thanks to this GMP infrastructure for the manufacturing of Phase I/II clinical batches, ASIT biotech is taking a major step towards the deployment of its ASIT+™ product portfolio designed to offer short course allergy immunotherapy to patients unsatisfied with current symptomatic treatments. I would like to thank our CMC teams, as well as those of our partner Accessia Pharma, for the smooth implementation of this unique site."

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