The new assays have been launched by SSB’s subsidiary Sartorius Stedim BioOutsource, a contract research organization (CRO).
According to the company, the pre-developed assays complement BioOutsource’s existing portfolio of more than 40 assays, in addition to expanding the number of molecules the company can support to nine molecules.
The new assays are for testing Actemra, Stelara, and Lucentis biosimilars, and include: Actemra IL-6R Neutralisation Bioassays, an Actemra IL-6R Binding ELISA, Stelara IL-12/IL-23 Binding Assays, a Stelara C1q Binding Assay, a Stelara Neutralisation bioassay, Lucentis VEGF Binding Assays, and a Lucentis VEGF Neutralisation Bioassay.
“We’re delighted to bring new assays for testing Actemra, Stelara and Lucentis biosimilars to market,” said Dr. Daniel Galbraith, Chief Scientific Officer of Sartorius Stedim BioOutsource.
“This means we can now offer biopharma companies a comprehensive range of ready-to-use assays, which they can trust to determine precise comparability results and accelerate their biosimilar drug development.”
SBB’s site recently passed FDA inspection in January 2016, during which its quality systems and their application to the analytical services that support biosimilar testing were reviewed over two days.
A BioOutsource representative told us, "The inspection showed that Sartorius Stedim BioOutsource is compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and not a single Form 483 observation for non-conformance was issued."