Born 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.
Dark Horse Consulting Initiative for Certification of Manufacturing Capabilities (ICMC™)
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
CoJourneyCoJourney is a cell and gene therapy contract development and manufacturing organization that develops and produces plasmids, viral vectors, sgRNA and exosomes from process development through GMP manufacturing and analytical testing. Its distinctive Zero Chrom® column-free plasmid platform is designed for high-purity production while reducing purification time and contamination risk. With more than two decades of team experience, FDA/EMA/NMPA-compliant facilities in Hangzhou and over 100 customers served, CoJourney supports programs from early development through clinical and commercial supply.HORSHAM, PA
Advanced BioScience Laboratories (ABL), IncFrom its Rockville base, Advanced BioScience Laboratories (ABL) develops and manufactures viral products for vaccines, gene therapies, oncolytic therapies and immunotherapies as a contract development and manufacturing organization. ABL brings more than 60 years of experience working with industry, government and academic partners, including over 30 years focused on viral-vector development and GMP production. Its Rockville facility is ISO 9001 accredited for viral drug-substance and aseptically prepared drug-product manufacturing, and the company has translated more than 100 processes from the laboratory bench into GMP suites.POTOMAC, MD
Patheon pharma servicesPatheon pharma services, part of Thermo Fisher Scientific, operates as a contract development and manufacturing organization serving biotechnology and pharmaceutical sponsors. It supports drug programs from early development and clinical supply through commercial production, and reports a global network of more than 60 locations. Its long-running specialties include viral vector manufacturing, with more than 20 years of experience, and sterile fill-finish and biologics expertise.ALLENTOWN, PA