Wacker Biotech works in accordance with pharmaceutical GMP (Good Manufacturing Practice) to ensure the high quality required for the approval of clinical studies or market approval by the American FDA (Food and Drug Administration) or the European EMA (European Medicines Agency). The production facilities at all three company sites are FDA and EMA certified.
Quality Assurance / Regulatory Affairs
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.
Amsterdam (the Netherlands)
The site in Amsterdam has been a licensed manufacturing plant for active pharmaceutical ingredients and small volume parenterals (SVPs) since 1992. In 2016, the Amsterdam site received FDA approval 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 Amsterdam is licensed by the Dutch authorities for the production of biopharmaceuticals for clinical use and market supply.
In addition, the facility has been successfully inspected by Brazilian ANVISA. The QM system and QC have been approved by FDA. The site in Jena is licensed by the German authorities for the production of clinical and market supply of biopharmaceuticals.
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 Halle is licensed by the German authorities for the production of clinical and market supply of biopharmaceuticals.
Our state-of-the-art microbiology, biochemistry and analytical chemistry labs offer certified analytical methods for biologics characterization for both drug substance and drug product. We offer validation of the analytical methods in accordance with current validation requirements as outlined in ICH Q2 guideline for validation of analytical procedures.
We follow GMP guidelines and meet the regulatory authorities’ requirements for the analytical determination of your product’s general characteristics, molecular structure determination, identity, activity, purity and safety, as well as the stability of the produced therapeutic proteins, vaccines and Live Microbial Products.
In our biochemistry and microbiology labs, we carry out the analysis necessary to maintain our GMP standards for raw materials, water and environmental control.