Founded 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.
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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
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
BioForgePittsburgh’s BioForge tackles the manufacturing challenges that keep precision medicines from reaching patients, developing scalable ways to produce biologic therapies and related technologies. A wholly owned subsidiary of the University of Pittsburgh, it works through small cross-disciplinary teams on fixed-budget, 18- to 36-month projects that must demonstrate results at convincing scale. Its fuRNAce initiative extends that mission by giving RNA designers a streamlined route to custom manufacturing through validated partners.PITTSBURGH, PA
Nitto AveciaNitto 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.CINCINNATI, OH