Method Development, Optimization and Validation

Identity, strength, quality, purity | 97% in house samples | deep technology infrastructure | process development focus | confident decision-making

The development of reliable analytical methods to monitor the quality attributes of a biologic or synthetic molecule is critical for guiding process and product development activities. Reliable analytical methods are also required to monitor the drug substance (DS) and drug product (DP) to ensure that applicable standards of identity, strength, quality, and purity are met.

We have deep analytical expertise and an in-house analytical infrastructure that allows us to characterize 97% of the samples we take within minutes of being extracted from the process. Our methods development experience has been applied to a variety of molecules including classic synthetics as well as recombinant proteins, mAb’s, vaccines, gene therapy products, and antibody-drug conjugates and our capabilities include HPLC, capillary electrophoresis, laser diffraction, DSC, SEM, TGA, qPCR, and TCDI50. 

Methods development, optimization, and validation, as well as process development support for our fast-moving scientists, is the daily business of our analytical group and our goal with every sample is to generate high-quality information that provides clarity for you and helps us make critical process development decisions with confidence.