Choosing the right partner for analytical and bioanalytical services is critical in the approval race. MilliporeSigma’s BioReliance® Testing Services offer exceptional, risk-mitigating solutions to help you bring life-changing drugs to market, faster. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Partner with us to meet your needs for Biologics Safety Testing, Product Characterization, Biomanufacturing Services, and Toxicology Services. See our full suite of capabilities.
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What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, how it behaves, and, most importantly, what effect it has on the patient.
Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.
Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be emoloyed.
The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to making informed decisions, accelerating development, and reducing risk.