Formed in 2018 to commercialize Applied DNA Sciences’ more than 20 years of enzymatic DNA expertise, LineaRx produces therapeutic LineaDNA™ through a proprietary, cell-free PCR process. Its linear DNA is made as an alternative to plasmid-based manufacturing, with applications including mRNA production and gene and cell therapies. Production is supported by a GMP-compliant facility operating within ISO 9001- and ISO 13485-based quality systems.
ISO 9001
ISO 13485
FDA 21 CFR Parts 210 and 211
Compliance program
FDA 21 CFR Part 820
Compliance program
Current Good Manufacturing Practices
Compliance program
GMP
Quality certification
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
Nitto AveciaNitto Avecia is a contract development and manufacturing organization (CDMO) specializing in the development and production of oligonucleotide therapeutics. With over 30 years of experience, the company has manufactured more than 1,200 different oligonucleotide sequences and supports programs from preclinical through commercial supply. Nitto Avecia operates FDA-inspected, GMP-compliant facilities in Massachusetts and Ohio, and is part of the Nitto Group, sharing a vision of 'Creating Wonders.'CINCINNATI, OH
GeneLancet BiosciencesEstablished in November 2019, Doylestown-based GeneLancet Biosciences develops in vivo gene and cell therapies built around its proprietary single-molecule guide RNA, or LgRNA. The company is advancing LgRNA-conjugate-guided STAR and DuoSTAR genome editors for precise treatments aimed at serious diseases including neurodegenerative disorders, cancer and chronic hepatitis B. Its platform emphasizes scalable, high-purity guide RNA and editing approaches designed to avoid double-strand DNA breaks and support repeat or multiplex treatment strategies.541714DOYLESTOWN, PA
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