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 safetyroute 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

Avid Bioservices is a U.S.-based biologics CDMO providing integrated mammalian cell culture process development, analytical development, formulation development, and CGMP biologics manufacturing from DNA to IND to commercial supply. It operates FDA-inspected CGMP facilities in California, including an early-phase center in Costa Mesa and commercial manufacturing in Tustin.

cell line developmentCGMP clinical manufacturingcGMP commercial manufacturingcontinuous processingdownstream processingfed-batch manufacturingformulation developmentmammalian cell cultureperfusion systemsprocess developmenttech transferupstream processing

Dipharma Inc. is a chemistry Contract Development and Manufacturing Organization (CDMO) based in Kalamazoo, Michigan, USA, whose scientists average 15 years' experience in pharmaceutical development from lead optimization through process development for clinical development. Its cGMP Kilolab and QC Laboratories manage supply for clinical Phase 1 and early Phase 2 deliveries, and it offers CRO services for synthetic projects.

cGMP manufacturingchromatographycustom synthesisDSCGChigh-pressure hydrogenationHPLCLC/MSNMR spectroscopyprocess impurity synthesisprocess route developmentQC laboratoriesXRPD

ElevateBio is an advanced therapies CDMO that partners with innovators to identify drug targets and manufacture clinical and commercial cell and gene therapy products. Its capabilities span discovery, gene editing design and optimization, process development, technology transfer, analytical development, next-generation sequencing, cGMP manufacturing, regulatory CMC, and quality, across modalities including cell therapies, viral vectors, mRNA therapeutics and vaccines, and gene editing.

automationcGMP manufacturinggene editing design & optimizationgenerative AInext-generation sequencingprocess developmentqualityregulatory CMCtechnology transfer