Analytics & Bioassays
Our integrated analytics approach facilitates your time to market goals, from method development and early material characterization to cGMP release testing and stability studies. Our solutions are efficient, reliable, and in compliance with regulatory standards.
Integrated Analytical Services for Biopharmaceuticals
Our interlocked analytical teams accompany the maturation of your product at any development stage. We provide a fit-for-purpose analytical tool kit, from cell line development to process batch release testing and stability studies supported by a strong microbiological unit and a dedicated bioassay team. Our experience in mammalian cell culture and analytics of glycoproteins assure the quality and safety of your drug candidate. With our expertise in new biologic formats beyond traditional antibodies, you can accelerate your development process, thereby reducing time to market.
Bioassays – More Than You Would Expect
What You Get
A fully integrated analytical team is the key to success and facilitates the entire cell line development workflow. Critical product attributes are identified and controlled right from the start, which enables the selection of high-quality clones in accordance with QbD principles (quality by design) for manufacturing. State-of-the-art equipment and methods include mass spectrometry, HPLC, capillary electrophoresis for size and charge variants, DNA sequencing (Oxford Nanopore Technologies), and digital PCR for genetic characterization.
Bioassay services are offered as an integrated part of our development and manufacturing solutions, as well as on a stand-alone basis for clinical candidates and commercial products (CRO services). Whether you're aiming for biosimilar development or mode-of-action analysis, our binding and cell-based bioactivity assays are fundamental for any activities extending beyond potency analysis.
Our Promise To You
One-Stop-Shop Services
- Our comprehensive analytical services help accelerate your development process by streamlining analytical activities from R&D to clinical batch release
- Development, manufacturing, and release are monitored and controlled by our close-meshed analytical services, from early molecular development to the release of drug substance and drug product (DS/DP)
For Tailored Solutions
- Our dedicated team offers in-depth characterization capabilities and regulatory expertise
- We provide client-focused project management for efficient and effective collaboration, delivering tailored solutions to meet specific needs
From Real Experts
- We offer extensive experience and a streamlined drug candidate development program for gylco-proteins and biopharmaceuticals, from antibodies to complex new formats and biosimilars
- We specialize in developing and validating robust platform methods for complex biologics beyond traditional antibodies, which ensures accurate and reliable testing for new biologic formats
