Analytical development at Richter-Helm BioLogics is set up to establish state-of-the-art, fully compliant solutions for your molecule.
We apply our extensive experience to devise appropriate solutions for each customer and product, develop or implement new analytical methods, and define a starting point for analytical lifecycle management. Our development services include but are not limited to:
Our development services include but are not limited to:
Establishment of product- and process-specific methods to accompany process development
Development of process-specific host-cell protein ELISAs
Development of bioassays for your molecule’s mechanism of action
Development of additional characterization methods for reference standards etc.
Development of methods for biosimilarity testing
Determination of stability indicating methods
We are also glad to act as a lead facility, coordinating and supervising the work of external laboratories as required for your project.