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Your Partner in Expert CMC Testing
A key advantage of partnering with Solvias for analytical CMC testing is the expertise and experience of our team. Our experts have the know-how, creativity, and tenacity to solve the analytical challenges associated with cutting-edge drug development.
Our 175+ PhD scientists have experience in
a wide range of cGMP testing modalities
Explore our expertise
Solvias’ Targeted Locus Amplification (TLA) technology helped us determine the specific location of each product-associated gene in our Working Cell Bank and End of Production cells with precision and depth that were unattainable by a different whole genome sequencing approach. These data contributed to the conclusion that our cell line is genetically stable across our manufacturing process and were instrumental in supporting the CMC aspects of our IND filing for the product. The Solvias contacts were professional, personable, attentive, and helpful throughout every step of the study, from experimental design to finalization of the study report.
The scientific delivery of this quality work from the Solvias team exceeded industry standards. The team are masters of their craft.
The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in vitro BE studies required for product filing at the US FDA.
The Solvias team’s expertise in genomic characterization has helped us establish the assays needed for each of our CRISPR genome-edited CAR-T cell therapies. (Click for full testimonial.)
