Development Services
CHARACTERIZE YOUR MOLECULE
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.
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Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA and other regulatory bodies
Pick your method from our large portfolio. All methods can be applied for development or GMP-compliant testing, depending on your needs.
