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Our Client & Quality Commitment
Our mission is to guide you from concept to commercialization of your product. We strive to meet the highest quality standards while closely and transparently collaborating with our clients.
Project Management
Excellent project management is an important and determining factor in the success of a project. Decades of experience in project management, expertise and efficient infrastructure are the basis for successful cooperation and the manufacture of biopharmaceuticals that meet the highest quality demands. Thus, dedicated project management is our top priority.
Each project is unique and requires an individual approach. We are firmly focused on customer requirements and possess the flexibility to take on projects at any phase. With multiple programs managed from feasibility to commercial approval, we have proven experience in swift and professional project management.
We always work in close collaboration with our customers. Our aim to achieve clearly defined and realistic targets is based on open and continuous communication. A dedicated project manager ensures focused and efficient project execution. Project managers are supported by teams of experts from the Bioprocess Development, Quality Control, Quality Assurance and GMP Manufacturing departments. Our experienced project teams work with strong focus providing consultancy and cutting-edge solutions while projects are running.
Quality Assurance
For cGMP-compliant production of biological active pharmaceutical ingredients, we set ourselves the highest standards with our pharmaceutical quality assurance system. Our quality management system is based on applicable local and international guidelines of FDA, EMA, ICH or WHO. Our sites have been approved by the FDA, EMA, ANVISA, MFDS (Korea), PMDA (Japan) and others for commercial manufacturing of different products.
Through our extensive quality assurance network, we manage all quality-relevant aspects including preparation of the necessary documents steering all aspects of manufacturing processes and process validation. Moreover, we put particular emphasis on regular and careful training of our employees, because only thoroughly implemented processes ensure the necessary quality of your products.
Our quality systems and compliance with cGMP requirements is verified by frequent authority inspections and client audits.
Over the years, Wacker Biotech has successfully supported its customers filing INDs, IMPDs, DMFs, MAAs and BLAs. Upon request, Wacker Biotech will draft CMC-related sections of your dossier/application. Wacker Biotech has a strong track record of supporting customers in manufacturing of clinical trial material and approved products.
Our services include:
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:
Better with WACKER
We look forward to bringing your biologics to life.