Bioassay Development
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.
Measurement of the biological Responsibility 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 Responsibility 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.
With an extensive choice of assay endpoints, our bioassay experts can assess a wide range of mechanisms of action including:
- Cell Proliferation
- Cell Death
- Antibody-Dependent Cellular Cytotoxicity (ADCC)
- Cell Signalling
- Cell Migration
- Receptor Binding
- Receptor Activation
- Ligand Binding
- Calcium Flux
- ELISA
Choosing the right partner for the development and operation of one of these assays is critical. BioOutsource scientists have a wealth of experience in a number of techniques and can advise on the best route for developing an assay, specific for your product.
During proof of concept studies, we can develop new methods or adapt discovery-based assays by applying in-house expertise to generate robust methods. Using statistical-based approaches, we are able to determine the most appropriate assay design, capable of meeting the rigorous demands of regulatory acceptance, whilst reducing the cost and timelines associated with the testing of your product. During this period, we are able to generate qualified, GMP-compliant cell banks, establish criteria for critical reagents and define the specifications of the Reference Standard that will enable a measure of relative potency.
What our clients say
“As an industry consultant for bioassay development it has been a pleasure to bring my clients to BioOutsource. Through the years we have worked together, BioOutsource has consistently provided a high quality professional service supporting the development and validation of potency bioassays. A combination of the technical and regulatory proficiency coupled with their flexibility, excellent communication, and dedication to each project’s timelines and goals, makes working with BioOutsource a truly collaborative and enjoyable experience that I would be very happy to repeat.”
Natalie Cohen - Owner NC Biologics Consulting