BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Stelara bioassays to support Stelara biosimilar manufacture and process development. We offer industry leading Stelara comparability and characterization services and these can be adapted to suit your Stelara material, if necessary.
We have extensive experience in the development, optimization and validation of custom cell based bioassays to assess the myriad of functions that can be mediated by monoclonal antibodies
The bioassay is the only analytical method that directly measures the biological activity of Stelara and therefore represents one of the most important assessments that should be conducted as part of product characterization, lot release and stability programs. The ICH guideline Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products describes the bioassay as:
Assessment of the biological properties constitutes an equally essential step in establishing a complete characterization profile. An important property is the biological activity that describes the specific ability or capacity of a product to achieve a defined biological effect.
BioOutsource offers the following Stelara bioassay:
If you require a Stelara bioassay method that is not listed, please contact us.