BioOutsource — cGMP compliant biotesting
Bioassay Services for Determination of Biological Potency
BioOutsource has established itself at the forefront of bioassay contract testing worldwide, providing assistance in all aspects of the biopharmaceutical and vaccine industries. Whatever your molecule, we can provide a dedicated one-stop service from bioassay development to GMP batch release, helping to accelerate your testing programmes.
Importance of Bioassays
Measurement of the biological activity is the most important test method required throughout the life cycle of all products. International Conference on Harmonisation (ICH) Q6B (Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) states:
"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."
Bioassays can be used for candidate selection, product characterisation, assessment of clinical efficacy, stability and ultimately for lot release of product.
