01.23.19
Sartorius Stedim Biotech (SSB) has launched services for new biological entities, called NBE Product Characterization, offered by its subsidiary, Sartorius Stedim BioOutsource, a contract testing organization based in Glasgow, UK, and in Cambridge, MA.
Sartorius Stedim BioOutsource provides a range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins. Tests include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses. These testing services are customizable for clients to help ensure drugs are tested based on the right regulatory requirements. Data packages proving the safety, purity and potency as required by the regulatory authorities, aim to smooth the submissions process for approval by the European Medicines Agency (EMA) and the U.S. FDA.
“We are really excited to bring to market this combined package of assay development and customizable off-the-shelf solutions for product characterization. With our unrivalled experience in biosimilars testing, combined with our proven expertise in NBE assay development, we have developed a panel of assays suitable for mAb characterization. This allows drug developers to fast-track complex bioassay development using our platform methods. With fully compliant cGMP facilities, we support our customers from early phase development to late phase and commercial release,” said Jennifer Lawson, Product Manager for Testing at Sartorius Stedim BioOutsource.
Sartorius Stedim BioOutsource provides a range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins. Tests include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses. These testing services are customizable for clients to help ensure drugs are tested based on the right regulatory requirements. Data packages proving the safety, purity and potency as required by the regulatory authorities, aim to smooth the submissions process for approval by the European Medicines Agency (EMA) and the U.S. FDA.
“We are really excited to bring to market this combined package of assay development and customizable off-the-shelf solutions for product characterization. With our unrivalled experience in biosimilars testing, combined with our proven expertise in NBE assay development, we have developed a panel of assays suitable for mAb characterization. This allows drug developers to fast-track complex bioassay development using our platform methods. With fully compliant cGMP facilities, we support our customers from early phase development to late phase and commercial release,” said Jennifer Lawson, Product Manager for Testing at Sartorius Stedim BioOutsource.
