In the complex field of biological-based therapeutic expression and production, specialist technical support is crucial. The collective expertise of our multi-disciplinary team in protein and gene-based therapies, from gene expression to commercial production, can support you in getting the most from our industry-leading technologies.
We have extensive experience in developing and delivering with market leading protein expression platforms.
Scalable and Regulatory-compliant Processes
We can help you develop robust, efficient, scalable and regulatory-compliant processes to equip you for ultimate commercial success.
>60 Molecules
In clinic manufactured with our expression platforms.
Expression technologies technical support
Let us help you express and scale your product to optimize your commercial potential. Our experts can provide you with detailed technical support to ensure you gain the full benefits from our advanced technology.
Our GS Gene Expression System® supports the optimal expression and production of monoclonal antibodies and next-generation biologics. The complete system includes host cell lines, vectors, access to optimized media and feeds, and process expertise.
Our XS Technologies® platform includes Pichia pastoris and Escherichia coli expression systems. With a selection of multi-host systems, we can address a diverse range of molecules.
Our bYlok® bispecific antibody engineering technology helps solve heavy-light chain mispairing whilst retaining closer-to-nature antibody structure and standard downstream purification.
Viral Vector production - proprietary technologies supporting viral vector production for cell and gene therapy applications.
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
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Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
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Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.