Nitto Avecia develops and manufactures therapeutic oligonucleotides, supporting pharmaceutical programs from preclinical material through commercial supply. The company was the first CDMO serving the oligonucleotide therapeutic market and has produced more than 1,500 sequences, with FDA-inspected facilities in Massachusetts and Ohio. Its Cincinnati site has maintained a 15-year record of FDA inspections with no action indicated, while its Milford facility recently earned ANVISA GMP certification for producing eplontersen sodium.
FDA-Registered Manufacturing Facilities
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cGMP per USFDA 21 CFR Parts 210 and 211
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ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
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EU Current Good Manufacturing Practice for Active Pharmaceutical Ingredients
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ANVISA GMP Certification
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ISO 8
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Ajinomoto Bio-Pharma ServicesWith more than 40 years in small-molecule manufacturing, Ajinomoto Bio-Pharma Services develops and produces pharmaceutical APIs and intermediates for drug companies worldwide. Its CDMO capabilities span the path from preclinical work through commercialization, while on-site analytical laboratories characterize molecules and support quality testing throughout their life cycle. Through Forge Biologics, a member of Ajinomoto Bio-Pharma Services, the company also provides AAV and plasmid manufacturing from preclinical through commercial stages.COLUMBUS, OH
Forge BiologicsFounded by gene therapy developers for developers, Forge Biologics is a Columbus, Ohio-based contract development and manufacturing organization focused on AAV gene therapy development and production. Its 200,000-plus-square-foot Hearth facility has 20 cGMP suites and supports programs from research through clinical and commercial manufacturing. Forge is part of Ajinomoto Bio-Pharma Services and brings more than 450 experts to its work with gene therapy developers.GROVE CITY, OH
Olon USAFounded in 1986 and acquired by Olon SpA in 2017, Olon USA is a contract research, development, and manufacturing partner focused on small-molecule drugs and other chemical-based industries. Its single 25-acre Concord, Ohio site brings together 160,000 square feet of laboratory and manufacturing space, with services spanning development through scale-up and production. The company reports that 71% of its chemists hold advanced degrees and that its quality system has supported audits by more than 200 clients and the U.S. FDA.CONCORD, OH
Andelyn BiosciencesBorn from decades of gene-therapy research at Nationwide Children’s Hospital, Columbus-based Andelyn Biosciences is a contract development and manufacturing organization that develops and produces viral vectors and plasmids for cell and gene therapies. Spun out as an independent company in January 2020, Andelyn carries a patient-centered origin story into work spanning early development through clinical and commercial manufacturing. Its two Ohio facilities support a record that includes more than 500 cGMP clinical batches and the production experience behind an FDA-approved systemic gene therapy.COLUMBUS, OH