Cell-Based Potency & Bioassays
Sartorius Stedim BioOutsource is an industry-leading provider of cell-based bioassays for monoclonal antibody (mAb) therapeutics. Our scientific team can support development, optimization, qualification and validation of the critical bioassays from simple primary potency measurements through to full characterization of the biological activity of a molecule. We have expertise in methods to measure recruitment of effector functions, induction or inhibition of a variety of secondary and tertiary activities, and antibody internalization. Our complementary range of binding assays, and full suite of analytical physicochemistry tests ensures a total solution for the characterization of your molecule.
Since 2007, BioOutsource has supported more than 30 projects per week with 99% on-time delivery. Our multi-site global lab space in Glasgow, UK; Laupheim, Germany; Cambridge USA; and Pangyo, South Korea ensure the capacity customers need to get to market. We welcome over 30 clients per year for full facility audits and our facilities have been successfully audited by the MHRA and FDA.
Cell-Based Assays That Deliver
The right partner is critical for the development and operation of cell-based potency and bioassays, as these are considered among the most challenging methods required during the drug development process. In addition to playing a key role in potency determination, in vitro bioassays allow true physiologically relevant measurement of the biological activity between a mAb, its intended target, and the Fc effector functions.
BioOutsource works to stay at the forefront of bioassay and potency assay contract testing worldwide employing experienced scientists and a wide range of innovative technologies and bioassay methods. Using a method lifecycle approach, our experienced team can provide critical guidance on the technical and regulatory aspects at all phases of drug development from discovery through to cGMP production for effective, cost-conscious total solutions.
A Range of Bioanalytics
Our broad range of platform methods ready to customize for your molecule include:
- Custom Potency Assays
- Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) Assays
- Antibody-dependent Cellular Phagocytosis (ADCP) Assays
- Complement-Dependent Cytotoxicity (CDC) Assays
- Immune Cell Assays
From early phase candidate selection and product characterization through to production, we provide an assay solution by the drug mechanism of action (MOA). Our assays enable flexible endpoints, allowing for a wider assessment of MOA including:
- Cell Proliferation
- Cell Death (Apoptosis)
- Cytokine Release
- Modulation of Cell Signalling
- Modulation of the Inflammatory Response (Immune Cell Function and Recruitment)
- Receptor Binding
- Receptor Activation
- Ligand Binding
- Calcium Flux
Assays can be performed using traditional endpoints of absorbance, Fluorescence, Luminescence and Fluorescence Resonance Energy Transfer (FRET), or more complex endpoints, such as:
Contact our expert scientists today to discuss how our range of analytical services can improve your unique process.