Rentschler Fill Solutions GmbH has received notification from the Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, 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 the international biotech and pharmaceutical industry specialist fill and finish services which range from GMP-compliant aseptic filling and freeze-drying to extensive analytics. The newly constructed, state-of-the-art facility went into operation in August 2018 and was initially certified by AGES for one year. 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, at the contract development and manufacturing organization, pharmaceutical and biopharmaceutical products are filled in vials of 2 to 50 ml for clinical and commercial use. The facility is designed for the flexible handling of small to medium sized batches of up to 60,000 vials and provides lyophilization capacity of 15m². Single-use equipment guarantees maximum product safety. Clients profit from comprehensive in-house testing, monitoring and analytics. The facility is designed to enable future expansion without interrupting ongoing operations.