Testing Services for Drug Development

We Provide a Unique Range of Integrated Testing Services to Support Biopharmaceutical Drug Development

Sartorius Stedim BioOutsource are a leading provider of cGMP, GLP, and GCP compliant contract testing services for the global biopharmaceutical industry. Our extensive suite of services combined with our technical and regulatory expertise make us the preferred choice for outsourcing your testing needs and accelerating your drug development program.

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Off-The-Shelf Assays

Reduce your biosimilar time to market with our high quality off-the-shelf assays

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Custom Assay Development

Can't find an assay for your molecule? No problem, we can develop a custom one for you

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Biosafety Testing

As leaders of cGMP and GLP biosafety testing we ensure your product is compliant with regulatory standards to ensure it is free of contaminants

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Discover Our Comprehensive Range of Testing Services

Analytical Testing for Innovator Molecules

We have a long history in providing product characterization for innovative new therapeutics, with over 10 years' experience in delivering testing for innovator products. We are experts in the development, optimization, and validation of complex cell based potency bioassays and binding assays. Coupled with our expertise in protein characterization provides a full range of integrated services for your New Biological Entity (NBE).

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Analytical Testing for Biosimilars

We are the market leader for biosimilar testing, supporting over 230 biosimilar development projects within our industry-leading portfolio of off-the-shelf cell based bioassays and binding assays, which we are continually expanding. Our clients appreciate our integrated service offering, providing you with one point of contact from DNA to clinic.

We provide off-the-shelf assays, custom assays, and biosafety testing for both biosimilar and innovator molecules. Our scientists are highly experience experts, and can provide technical and regulatory guidance and support throughout your drug development project.

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