NBE Product Characterization
BioOutsource is leading Contract Testing and Research Organization (CRO) that delivers analytical testing services to global biopharmaceutical researchers, developers and manufacturers. Our range of biological, physicochemical, and structural analyses of biologic drugs is carried out by a team of scientists who have the knowledge to partner with you, and care about the data produced. Over the years, we have worked to build extensive technical and regulatory expertise so that we can successfully develop and commercialize innovative biotherapeutic products that reflect our passion for the advancement of the industry.
Scalable Off-the-Shelf and Custom Analytical Services
Services are scaled to each phase of the drug development process, and can include development, qualification and validation of product characterization assays, such as cell-based potency assays, binding assays and physicochemical tests. Our panel of assays which have been pre-qualified with commercial monoclonal antibodies can help shorten your analytical development timelines. The range of analytical testing services we offer for the characterization of biologic products from pre-clinical development through to commercialization is backed by experienced scientists that care about the outcome.
BioOutsource has extensive technical and regulatory knowledge in the following areas:
Complementary development and testing services include:
- Cell Line Development
- Cell Bank Manufacturing
- Biosafety Testing
- Cell Bank Characterization
- GMP Lot Release
Over a Decade of Client Success
Since 2007, we have partnered with start-ups and educators, as well as pharmaceutical manufacturers and research associations — a part of the job that reflects the passion in our team.
We are driven to help bring drug products to market safer, faster and more cost-effectively, so that our customers can have a true impact on patient health globally. Contact us today to see how we can be your trusted partner in:
- Binding and potency assays for your innovator molecules
- Efficient, reliable analysis and optimization
- Biological, chemical, and structural analysis of biologics
- Assay optimization, qualification and validation