BRIEF—ASIT bi otech set to make API for the Phase I/II allergy studies

Belgium’s ASIT Biotech today announced that it has installed and qualified in a clean room the equipment to produce, in compliance with Good Manufacturing Practices (GMP) requirements, the active pharmaceutical ingredient (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 first-half 2019.