Brief: ASIT Biotech Installed And Qualified Pilot Unit To Produce Clinical Batches For Phase I/II Studies In House Dust Mite And Peanut Allergies

European Medical Solutions SA

26/11/2018 06:06

Nov 26 (Reuters) - ASIT BIOTECH SA  ASIT.BR :
    * ASIT BIOTECH HAS INSTALLED AND QUALIFIED A PILOT UNIT TO PRODUCE CLINICAL BATCHES FOR THE
PHASE
I/II STUDIES IN HOUSE DUST MITE AND PEANUT ALLERGIES EXPECTED TO START IN H2 2019
    * GRANTING OF GMP CERTIFICATION, MANUFACTURING OF FIRST CLINICAL BATCHES AND THEIR RELEASE
ARE
EXPECTED H1 2019
    * DEPLOYMENT OF OVERALL QUALITY SYSTEM AND ASSOCIATED DOCUMENTATION SYSTEM IS COMPLETED AND
A GMP
CERTIFICATION REQUEST HAS BEEN FILED WITH BELGIAN REGULATORY AUTHORITIES
    * ACTIVE PHARMACEUTICAL INGREDIENTS (API) WILL BE PRODUCED ACCORDING TO GMP REQUIREMENTS IN
A
CLEAN ROOM RENTED FROM ACCESSIA PHARMA, A PROVIDER OF HIGH-QUALITY PHARMACEUTICAL
INFRASTRUCTURES
    * EXPECTS GRANT OF GMP CERTIFICATION BY BELGIAN REGULATORY AUTHORITIES, AS WELL AS RELEASE
OF
FIRST CLINICAL BATCH OF PNT-ASIT+ FOR FIRST-IN-MAN STUDY IN PEANUT ALLERGY, IN H1 2019

Source text for Eikon:  ID:nBw8SQ1dsa 
Further company coverage:  ASIT.BR 

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