analytical development

A1 BioChem Labs (ABCL), a subsidiary of Apitoria Pharma Private LTD, is a CRDMO offering comprehensive chemistry services to pharma, biotech, and academia. It operates advanced labs in Wilmington, NC, and Hyderabad, India, specializing in custom synthesis, medicinal chemistry, route scouting, analytical development, and commercial-scale manufacturing across FDA, EDQM, and PMDA approved sites.

chemical sourcingchiral analysisCMC supportcommercial-scale manufacturingcustom synthesisDMPKflow chemistrygenotoxic impurity assessmenthigh-vacuum distillationhydrogenationmedicinal chemistrynitrosamine controlparticle-size distributionpolymorphismpowder processingprocess developmentprocess safetyPSC 6850route scoutingsolid-state analysis

Andelyn Biosciences is a full-service cell and gene therapy CDMO based in Columbus, OH, spun off from Nationwide Children's Hospital in January 2020. It provides viral vector and plasmid manufacturing, process development, laboratory services, technology transfer, and its AAV Curator® Platform from preclinical to commercial cGMP production.

AAV Curator® PlatformcGMP manufacturingplasmid manufacturingprocess developmentquality controltechnology transferviral vector manufacturing

Artis BioSolutions is a synthetic DNA and advanced therapy platform company that combines proprietary enzymatic, cell-free synthetic DNA production (oDNA) with advanced therapy development and GMP manufacturing. It operates in the United States and European Union, with GMP and RUO manufacturing in Watertown, MA and Bilbao, Spain, supporting mRNA, gene editing, viral vectors, cell therapies, vaccines, and emerging biologics.

AAV viral vector manufacturingCMC strategyenzymatic cell-free synthetic DNA manufacturingfill/finishGMP manufacturinglentiviral vector manufacturingLNP formulationmRNA manufacturingprocess developmentquality control