New biological entities testing is available as off-the-shelf or custom assays for more complex proteins
Sartorius Stedim Biotech has launched services for new biological entities NBE, product characterisation. These services are offered by its subsidiary, Sartorius Stedim BioOutsource. The company provides a comprehensive range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins.
Jennifer Lawson, Product Manager for Testing at Sartorius Stedim BioOutsource, commented: “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 characterisation. This allows drug developers to fast-track complex bioassay development using our platform methods."
An experienced, contract testing organisation, Sartorius Stedim BioOutsource operates from offices in Glasgow, UK, and in Cambridge, Massachusetts, US. There are fully compliant cGMP facilities designed to supports customers from early phase development to late phase and commercial release.
The range of available testing services include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses, enabling customers to benefit from a fully integrated package.
These testing services are fully customisable for clients to ensure their innovator drugs are tested based on the right regulatory requirements by expert scientists.
In addition, robust data packages proving the safety, purity and potency as required by the regulatory authorities are available to smooth the submissions process for approval by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
These fully customizable methods and data packages for monoclonal antibody characterisation complement BioOutsource’s and Sartorius Stedim Cellca’s existing innovative offer for biologics. Thus, pharmaceutical companies can now work with one contract partner from cell line development to qualification and validation of analytical and biological product characterisation assays.