Quality Assurance - Wacker Chemie AG


Quality Assurance

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Wacker Biotech holds biomanufacturing certificates from the relevant authorities for all sites, and follows the ICH Q7 guidelines for GMP-compliant production of active pharmaceutical ingredients (APIs) and Drug Product (DP). All three GMP production facilities are approved for commercial manufacturing by EMA, U.S. FDA and/ or ANVISA.

With more than 1,100 released batches Wacker Biotech has a strong track record in supporting clients over the years with manufacturing of clinical trial material and approved products. Over the years, Wacker Biotech has successfully supported its customers in filing of INDs, IMPDs, DMFs, MAAs and BLAs. Upon request, Wacker Biotech will draft CMC related sections of your dossier/application.

The site in Amsterdam (the Netherlands) is licensed by the Dutch authorities for the production of biopharmaceuticals for clinical use and market supply. It has been a licensed manufacturing site for active pharmaceutical ingredients and small volume parenterals (SVPs) since 1992. The site is approved by FDA for production of a cholera vaccine (trade name: VaxchoraTM) marketed by PaxVax. In addition, the facility has been inspected and approved by several other international regulatory authorities, such as Korean MFDS, Brazilian ANVISA and Health Canada.

The site in Halle (Germany) is licensed by the German authorities for the production of clinical and market supply of biopharmaceuticals. This facility is EMA- und U.S. FDA-approved for the commercial production of Reteplase Drug Substance (trade names Rapilysin®, Retavase®), a thrombolytic drug that is indicated to treat acute myocardial infarction. In addition, the facility has been inspected and approved by several other international regulatory authorities, such as FDA and Ministry of Health Turkey.

The site in Jena (Germany) is licensed by the German authorities for the production of clinical and market supply of biopharmaceuticals. In 2016, the Jena plant received EMA approval for drug substance manufacturing for Spectrila®, a recombinant L-asparaginase to treat childhood leukaemia. In addition, the facility has been successfully inspected by Brazilian ANVISA.

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Contact

Wacker Biotech GmbH
Jena and Halle (Germany)
Tel. +49 3641 5348-150

Wacker Biotech B.V.
Amsterdam (the Netherlands)
Tel. +31 20 750 3600