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.
Discover Our Expert Solutions
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).
Discover more about how we can support your innovator molecule.
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.
Nivolumab (Opdivo®️) and Anti-PD-1 Molecules
Checkpoint inhibitors have gained more traction as an essential mechanism in the treatment of cancer. Programmed cell death protein 1 (PD-1) is an immune checkpoint found on cells involved in regulating the immune system's response to self-cells by down-regulating the immune response and promoting self-tolerance by suppressing T cell inflammatory activity. Therefore, PD-1 has a vital role in preventing autoimmune diseases but can also prevent the immune system from killing cancer cells.
Nivolumab, a fully human IgG4 molecule and other anti-PD-1 molecules, has revolutionized cancer treatment by acting as checkpoint inhibitors, blocking the interaction between PD-1 and its ligand (PD-L1 and PD-L2), which would typically lead to the inhibition of T cell activation. Biosimilars have the potential to provide more affordable healthcare and expand patient access to biologics.
Available Assays
Sartorius offers a complete characterization package for innovator and biosimilar nivolumab, increasing speed to market while reducing biosimilar manufacturers' in-house development costs. Sartorius can build a package to suit your characterization needs from structure to binding to function.
Molecule | Pembrolizumab | Nivolumab | Cemiplimab |
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Ig Subtype | IgG4 | IgG4 | IgG4 |
Target | PD-1 | PD-1 | PD-1 |
SPR |
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ELISA Binding |
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FACS (binding) |
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Reporter Bioassay |
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ADCC |
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CDC |
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ADCP | |||
T Cell Proliferation/Activation |
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T cell Exhaustion |
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Structural Analysis and Confirmation |
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Other |
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