cGMP manufacturing

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing and delivering cell and gene therapies for serious diseases with high unmet need. Its ZEVASKYN (prademagene zamikeracel) was approved in April 2025, and its fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. Its development portfolio features PSMA-SIR-T, an engineered T-cell therapy targeting Prostate-Specific Membrane Antigen.

cell and gene therapy developmentengineered T-cell therapyex vivo gene therapyviral vector technologies

Abzena is a fully integrated biologics and bioconjugates CDMO+CRO, founded in 2001, providing discovery through commercial services for antibodies, ADCs, AOCs, RDCs, vaccines, fusion proteins, bispecifics and other complex biologics. It operates integrated facilities in San Diego CA, Bristol PA, and Cambridge UK, with corporate headquarters in Raleigh, North Carolina, and has partnered with over 500 customers globally.

analytics and bioassaysantibody discoverybioconjugationcell line developmentcomplex chemistryformulation developmentHPAPI handlingimmunogenicity testingprocess developmentprotein engineeringtechnology transfer

AGC Chemicals Americas, Inc. is headquartered in Exton, PA and is described as a leading producer of sustainable fluorotechnologies, compounds, and specialty materials. It offers a broad range of high-performance fluoropolymers including fluoroelastomers, PFA and ETFE resins, fluoropolymer compounds, and chemical membranes, serving markets such as aerospace, construction, electronics, energy, transportation, industrial, and life sciences.

CDMO for small molecule APIscustom compoundsenvironmental and accelerated aging studiesfluoropolymer compoundingResearch and Development

Aldevron is a global manufacturer of plasmid DNA, mRNA, proteins, and enzymes for gene therapy, cell therapy, and RNA programs, offering development and manufacturing services from discovery through clinical trials to commercialization. The company provides cGMP and GMP-Source quality manufacturing, process development, and regulatory support for viral and non-viral vector therapies.

custom protein manufacturingfill/finishGMP-Source manufacturingin vitro transcriptionLNP encapsulationplasmid designprocess developmentQC testingregulatory supportRNP production

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® Platformanalytical developmentplasmid manufacturingprocess developmentquality controltechnology transferviral vector manufacturing

Animal Science Products, Inc. is a family-owned and operated business serving the feed additives and animal health industries from Nacogdoches, Texas, since its founding in 1985. ASP is a specialty product provider to the feed and food animal production industry with sales throughout the U.S. and in more than forty countries. Its factory produces animal feed and water additives in an FDA-licensed facility inspected under Texas State and U.S. federal FDA authorities to cGMP regulations.

animal feed and water additive manufacturingFDA-licensed facilitygel delivery systemsvaccine stabilization

APAC Pharmaceutical, LLC is a chemistry company specializing in process research, scale-up, and pilot-manufacturing, with a niche for complex multi-step synthesis and scale-up under cGMP conditions. It provides chemistry and manufacturing solutions for specialty chemical, pharmaceutical, and bio-tech companies, including advanced intermediates and active pharmaceutical ingredients (API). Its platform is a hybrid US-China operational model with research in the US and China and manufacturing from China facilities.

carbohydrate chemistrychiral chemistrycomplex multi-step synthesisGCheterocyclic chemistryHPLCnucleoside/nucleotide chemistrypilot manufacturingprocess researchscale upsynthetic peptide chemistry

Apocus is an FDA-registered 503B outsourcing facility in San Antonio, Texas, supplying cGMP-compliant, batch-tested office-use compounded medications to clinics, hospitals, and practices. Its sister pharmacy ApocusRx handles 503A patient-specific compounding. Apocus operates under FDA cGMP requirements with documented batch records, validated processes, and independent release testing on every production run.

503A patient-specific compounding (via ApocusRx)503B outsourcing facility compoundingbatch testingindependent release testing

Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative science and delivery technologies. It has produced over 2.5 billion PharmFilm doses and offers a full suite of CDMO capabilities, including formulation development, cGMP-compliant manufacturing, and packaging solutions.

batch blendingcontrolled substance handling (DEA-registered)DSCSA-compliant systemsformulation developmentPharmFilm technologyprimary and secondary packagingprocess validationregulatory guidanceserialized packagingTech transfer

Avanti Research, a Croda brand, provides high-purity lipids and lipid research tools for scientific research. The company offers research products, custom synthesis, cGMP manufacturing, analytical services, lipidomics, formulations development, and extruder kits. Founded in 1967 in Richmond, Virginia by Dr. Walter A. Shaw, it moved to Pelham, Alabama in 1973, to Alabaster, Alabama in 1990, and was acquired by Croda International Plc. in 2020. The Avanti Research brand launched in 2024.

analytical servicescontract manufacturing and packagingcustom synthesisformulations developmentlipidomicsscale-up manufacturingsynthetic and analytical chemistry

BioCytics, founded in 2005, is a privately held health technology and biotechnology company located in Huntersville, North Carolina, focused on cancer immunotherapy. It researches autologous Adaptive Cell Therapy (AACT) to develop an immuno-oncology platform for treating solid tumors with the patient's own immune cells, and offers CDMO, CRO, laboratory, and biobank services.

biospecimen bankingcell manufacturing at point of careclinical lab diagnosticsclinical trial managementprocess and assay developmentregulatory compliance and IND submissionstranslational analytical services

BioFactura, Inc. is a clinical-stage biopharmaceutical company based in Frederick, Maryland that develops and manufactures high-value biosimilars, biodefense medical countermeasures, and client-selected novel drugs. Founded in 2004, it leverages its patented StableFast-NS0 Biomanufacturing Platform and CHO expression systems. Programs include biodefense drugs against smallpox and Ebola, novel cancer medicines, and biosimilars for autoimmune and infectious diseases. It launched Capitol Biologics, a CDMO division, in 2025.

analytical assay developmentbioprocess developmentchromatographycontinuous perfusion bioreactor productiondownstream recovery and purificationLC-MS/MS characterizationmammalian cell culturemanufacturingscale up

Bio-Synthesis is a U.S.-based custom synthesis and chemistry development CDMO supporting nucleic acids, peptides, bioconjugation, molecular biology services, analytical testing, scale-up, and therapeutic development workflows. Founded in 1984, it operates a 75,000 sq. ft. facility in Lewisville, Texas, with cGMP-aligned manufacturing from preclinical to commercial scale.

analytical testingbioconjugationHPLC purificationmass spectrometry (MALDI-TOF, LC-MS, ESI)molecular biologyoligonucleotide synthesisPAGE purificationpeptide synthesisscale-up manufacturingtangential-flow filtrationUV spectrophotometry

BioXtek is a regenerative medicine company that processes human placental tissues and birth byproducts into pharmaceutical-grade biologic therapies. It operates an 11,000 sqft cGMP/AATB facility that is FDA registered and inspected, and is AATB accredited. The company manufactures placental membrane patches and placental-derived exosome and stem cell products for regenerative therapeutics.

3D cell culturecGTP processingcryopreservationextracellular matrix processinglyophilization

Boston Cell Standards (BCS) brings modern Quality techniques of Calibration and Statistical Process Control (SPC) to IHC lab testing, which is used for diagnosing and treating cancer patients. BCS aims to reduce IHC lab testing error rates from current levels of 10%-30% to <1%. The company has spent more than 20 years developing technologies to bring modern Quality practices to IHC, with its story beginning in 2003.

calibrationImmunohistochemistry testing standardsStatistical Process Control (SPC)

Captivate Bio is a cell culture solutions provider and distributor of media, buffers, serum, and custom services to the life sciences. It offers over 1,000 RUO and GMP-grade products, US manufacturing and distribution, and custom media services, serving stem cell, cell and gene therapy research communities.

buffers and salt solution manufacturingcontract media manufacturingcustom media formulationcustom reagent sourcingISO-certified facility manufacturinglogistics servicesstorage and fulfillmentUS manufacturing and distribution

Cell Therapy Tools provides tools, reagents, and services for cell therapy, including convenient kits for separation of platelet-rich plasma from whole blood. The company operates a certified cGMP facility producing autologous and allogeneic cell products, and offers mobile PRP and laser-activated PRP services in Orange County and Los Angeles. It uses patented low level laser activation technology and automated devices for laser activation of cell products and body fluids.

endotoxin testinglow level laser activationmobile servicesMSC bankingmycoplasma testingsterility testing

Cetylite, Inc. is a privately-owned, third-generation family-owned specialty manufacturer of chemistry-based products for the healthcare industry, serving medical, dental and veterinary providers. Founded as a molded plastics company in 1945 and shifting to cleaning and disinfecting supplies in 1947, it engineered the world's first concentrate formula for disinfecting instruments and hard surfaces in 1955. Its products include prescription topical anesthetics, infection control and disinfection products, and complementary dental products, distributed thr

distributionformulationpackaging

Dendreon is a commercial-stage biopharmaceutical company and end-to-end provider of manufacturing services for the cellular therapy market. It was the first company to successfully develop and commercialize an immunotherapy made from a patient's own cells, gaining FDA approval for PROVENGE (sipuleucel-T) in 2010, which has been prescribed to nearly 40,000 men with advanced prostate cancer.

apheresis managementautologous and allogeneic cell therapy manufacturingcell-based potency assayscellular therapy manufacturingclinical and regulatory supportendotoxin testingflow cytometrylogistics and delivery of time-critical therapiesPCRprocess and analytical developmentquality control testing

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.

analytical developmentchromatographycustom synthesisDSCGChigh-pressure hydrogenationHPLCLC/MSNMR spectroscopyprocess impurity synthesisprocess route developmentQC laboratoriesXRPD

Direct Biologics is developing investigational, secretome-based product candidates derived from adult bone marrow mesenchymal stem cells for evaluation in clinical research. The company uses cGMP manufacturing processes designed to support consistency, scalability, and quality from sourcing through characterization. Its operations are based in Texas and California, with team members collaborating across multiple locations throughout the United States. Direct Biologics was founded in 2017 by Mark Adams and Joe Schmidt.

clinical researchquality controlResearch and Development

Double Wood Supplements sells potent, single-ingredient dietary supplements and supplement stacks. Products are third-party tested, with Certificates of Analysis made available, and manufactured in the USA in a cGMP facility with global ingredients. The company offers a 30-day money back guarantee and organizes products by health categories such as sleep, brain health, heart and vascular, immune health, and men's health.

supplement formulationThird party testing

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.

analytical developmentAutomationgene editing design & optimizationGenerative AInext generation sequencingprocess developmentqualityregulatory CMCtechnology transfer

Eliksa Therapeutics is a pioneering biotechnology company dedicated to addressing rare diseases, specializing in developing innovative treatments for unmet medical needs. Its products leverage the regenerative potential of specialized biological components, processed in a cGMP regenerative medicine facility. It focuses on ocular manifestations of Epidermolysis Bullosa, with its investigational ophthalmic drug ELK-003 delivered as eye drops.

regenerative medicinespecialized processing and sterilization methods