Rentschler Fill Solutions GmbH, a contract development and manufacturing organization (CDMO) for aseptic filling and finishing of biopharmaceuticals, received notification from the Austrian Agency for Health and Food Safety (AGES) that the pharmaceutical manufacturing license for the European market and the certificate for GMP conformity will be extended for an unlimited period of time.

Rentschler Fill Solutions offers specialist fill and finish services which range from GMP-compliant aseptic filling and freeze-drying to extensive analytics. The company’s newly constructed facility went into operation in August 2018 and was initially certified by AGES for one year, per common procedure. As part of a routine follow-up examination at the end of the first year of operation, the time limit has now been lifted.

Onsite, pharma and biopharma products are filled in vials of 2 to 50 ml for clinical and commercial use. The facility is designed for the handling of small to medium sized batches of up to 60,000 vials and provides lyophilization capacity of 15m².