New Biological Entity - Product Characterization Services

The foundation for approval of new biological entities is built on a robust analytical data package that proves the safety, purity and potency of the product. The BioOutsource analytical testing package combines physicochemical and biological analysis for in-depth characterization studies from a single contract partner. Our service offering uses platform methods, off-the-shelf assays and custom developed bioassays to enable rapid data-driven decisions during drug development and is available from pre-clinical through to clinical phases and lot release. Coupled with our extensive options for biologics safety testing, and the wider Sartorius portfolio, Sartorius Stedim BioOutsource is the leading service provider, and preferred choice for your program.

We have extensive expert knowledge to support your New Biological Entity (NBE) with our off-the-shelf & custom assays, as well as regulatory compliant biosafety testing in the following areas:

• Bioassays
• Cell-based Potency Assays
• Binding Assays
• Physicochemical & Structural Analyses
• Qualification & Validation