Developing a robust, scalable manufacturing process, and producing safe and effective vaccines that meet global regulatory requirements is a technical challenge. Our process development and GMP manufacturing services help you every step of the way, from concept and strain construction to preclinical assessment. We provide comprehensive support and expertise to turn your promising research into clinical batches, whether viral, bacterial, or oncological vaccines. With a variety of production technologies in single-use and stainless-steel bioreactors with up to 200 L capacity, 230 sqm of GMP cleanrooms (class C) and quality control, and a reliable network of service partners, we can produce vaccines for testing in phase I/II clinical studies.
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Our QC expertise includes assay validation, sampling and testing of raw materials, and management and execution of stability and release testing for your vaccine in compliance with GMP.
General (microbiological) analytical techniques are outsourced to our preferred partners. These techniques include assessments of sterility, bioburden, endotoxin, mycobacteria, and mycoplasma, particulate matter subvisible, TOC and nitrates, as well as DNA fingerprinting and deep sequencing.
QC includes support in the development and validation of product specific analytical techniques at the highest standards of quality. Validation of assays is performed according current ICH Q2 guidelines.
With state-of-the-art manufacturing facilities and a wide range of analytical techniques, we offer focused and customized support for your vaccine development project. Furthermore, our clinical, quality affairs, and regulatory teams have the expertise needed to comply with the latest GMP standards.