CMC Analytical Development CDMOs in United States
97 published
97 published CDMOs match CMC Analytical Development in United States.
Locations in this set include United States, United Kingdom, China, Germany, Japan, and India.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Gene Therapy, and Cell Therapy.
Matching companies
Kindeva Drug DeliveryPurpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities.
LifecoreLifecore is a sterile injectable CDMO with 60 years of regulatory experience, offering end-to-end services including formulation and process development, aseptic manufacturing, fill-finish, analytical testing, stability, and assembly and packaging for drugs, biologics, medical devices, and combination products.
Made ScientificCell therapy CDMO offering end-to-end development, GMP manufacturing, and regulatory support from preclinical through commercial scale, with specialized expertise in T cells, NK cells, MSCs, iPSCs, and other cell modalities.
MedpharmSpecialized CDMO for topical, transdermal, and transepithelial drug products offering formulation development, analytical testing, process scale-up, and GMP manufacturing from early development through commercialization.
MicromacinazioneSwiss-based CDMO specializing in particle engineering and micronization with over 50 years of experience. Offers micronization, milling, spray drying, solid-state characterization, and complementary processing services (classification, blending, cryogenic, co-micronization, conditioning) for APIs, HPAPIs, controlled substances, and excipients from early development to commercial GMP scale.
Minaris Advanced TherapiesPure-play cell and gene therapy CDMO with over 25 years of GMP manufacturing, process development, and biosafety testing expertise. Serves advanced therapy innovators globally from early stage through commercialization.
National ResilienceEnd-to-end CDMO specializing in complex modalities including cell, gene, and RNA-based therapies with North American manufacturing facilities and development capabilities.
Northway BiotechEnd-to-end CDMO specializing in protein-based biologics and gene therapies, with 20+ years of expertise and cGMP facilities in Lithuania and Massachusetts supporting development from preclinical to commercial stages.
Onyx ScientificSmall molecule CDMO specialising in process chemistry, solid-state chemistry, and API manufacturing for Phase I–III and commercial supply. Licensed for commercial API production at its Sunderland, UK facility, with a second site in North Carolina, US.
Oxford BiomedicaGlobal viral vector CDMO with 30 years of expertise in lentivirus, AAV, and adenovirus manufacturing. Provides end-to-end development and GMP-compliant manufacturing services from preclinical through commercial launch for cell and gene therapy programs.
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.
PharmaBlockLeading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.
Pharmaceutics International, Inc.Drug product CDMO specializing in aseptic injectables, oral solid dose, lyophilization, and prefilled syringes with 30+ years of experience in complex formulations and potent compounds; now part of Jabil.
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.
PluriFull-service CDMO specializing in cell therapy manufacturing with GMP facilities, proprietary packed-bed expansion technology, and regulatory approvals from FDA, EMA, PMDA, and other key agencies for clinical-stage production.
PortonPorton is a global CDMO offering integrated manufacturing and development services across small molecules, peptides, oligonucleotides, biologics, and conjugates with specialized capabilities in flow chemistry, biocatalysis, and advanced therapies.
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.
Pyramid Pharma ServicesUS-based aseptic fill-finish CDMO specializing in parenteral biologics, peptides, and small molecules from development through commercial supply, with formulation, analytical, stability testing, and vial/syringe/cartridge filling capabilities.
Quotient SciencesIntegrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.
ROISSterile fill-finish CDMO for biologics, vaccines and ADCs, offering prefilled syringes, cartridges and vials across five US and European sites. It also supports oral solid dose manufacturing and drug substance development.
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