Quality Control

Our state-of-the-art microbiology, biochemistry and analytical chemistry labs at all sites offer certified analytical methods for biologics characterization. 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, live microbial products, plasmid DNA, mRNA and LNPs.

Our services include:

Quality system inspected by FDA, EMA, ANVISA (Brazil), MFDS (Korea), PMDA (Japan) and others
GMP and manufacturing licenses according to applicable local law
Release of batches by Qualified Person (QP)
30+ years of commercial bioproduction without critical or major findings by authorities
Quality support through the whole lifecycle of your product
Review and support of writing of the CMC-related sections of your dossier or application

Better with WACKER

We look forward to bringing your biologics to life.

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