- About
- Main Menu
- Main Menu
- Leadership Team
- Our History
- Locations
- Capabilities
- Main Menu
- Main Menu
- Bioconjugates & Chemistry
- Biologics
- Resources
- Careers
- Contact
Reliable methods to characterize your product
Accelerating your path to the clinic, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND and marketing applications as you move towards commercialization.
Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies. We provide transparent and regular communications to ensure we meet your program goals and timelines.
Our approach focuses on developing and qualifying phase appropriate assays for a spectrum of safety, potency, purity, identity, and extended characterization that enable end-to-end support for:
Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging state-of-the-art instrumentation and a molecule-specific, customized approach to method development, qualification, and testing. Methods can be developed de novo or transferred in from external laboratories.
By understanding your molecules’ attributes, we support future development activities with customized characterization assays. Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports cell line, process, and formulation development, and/or bioconjugation.
Our capabilities utilized to support bioconjugation include the following:
The asset you’re developing right now can make a real difference for human health. Let us apply our wealth of experience to accelerate and maximize its potential.