CDMOs offering CMC Regulatory Submission Support with mRNA
17 published
17 published CDMOs match CMC Regulatory Submission Support and mRNA.
Locations in this set include United States, China, Belgium, Denmark, Germany, and India.
Capabilities that show up most often in this set: CMC Analytical Development, mRNA Manufacturing, Process Development, Technology Transfer, and Sterile Fill-Finish & Aseptic Manufacturing.
Matching companies
AGC BiologicsGlobal CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities.
AldevronAldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization.
BioVectraNorth American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.
Biomay AGGMP CDMO specializing in plasmid DNA, mRNA, and recombinant protein manufacturing from gene construction to market supply, with in-house mRNA lipid-nanoparticle formulation and aseptic fill-finish capabilities.
BiospringGlobal CDMO leader in nucleic acid manufacturing and analysis (mRNA, ASO, siRNA, guide RNA, oligonucleotides) with nearly three decades of expertise, GMP certification since 2007, and support for 9 commercial programs across all clinical phases.
CordenPharmaFull-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.
CuriaGlobal CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.
ElevateBioAdvanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale.- HillgeneHillgene is a leading CDMO provider specializing in cell therapy manufacturing, offering end-to-end solutions for CAR-T, TCR-T, CAR-NK, and UCAR-T cell therapies with GMP facilities in Suzhou and Belgium.
Hongene Biotech CorporationHongene is a vertically-integrated CDMO offering end-to-end oligonucleotide and mRNA manufacturing from raw materials to GMP drug product, with nearly 30 years of RNA-focused expertise and tonne-scale production capacity.
Patheon (Thermo Fisher Pharma Services)Patheon is a trusted global contract development and manufacturing organization (CDMO) partner owned by Thermo Fisher Scientific, offering 360° integrated solutions from early-stage R&D through clinical supply and commercial manufacturing.
PharmaronPremier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
Porton AdvancedEnd-to-end ATMP CDMO provider offering cell engineering, lentiviral vectors, mRNA/LNP, plasmid development, and GMP manufacturing from preclinical through commercialization with 24 IND approvals across NMPA, FDA, and MedSafe.
Samsung BiologicsLeading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
Sophia CDMOEuropean CDMO specializing in microbial and precision fermentation up to 40,000 L across two integrated sites (Pamplona, Spain and Basel, Switzerland), with core strengths in E. coli expression, animal health biologics, probiotics, and complex CMC programs requiring scale-up discipline and impurity control.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
eXmoor PharmaIntegrated cell and gene therapy CDMO with 20+ years of consultancy expertise, offering end-to-end CMC support from early-phase strategy through GMP manufacturing across viral vectors, autologous/allogeneic cell therapies, and RNA technologies.
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