10-cdmo-up-&-comers
10 CDMO Up & Comers

10 CDMO Up & Comers

Credit: Charles River Laboratories

Ardena

  • Acquired Catalent’s Somerset, NJ, oral solids development and small-scale drug product manufacturing facility for an undisclosed price, in a deal completed in February.
  • In Somerset, expanded its Bioanalytical Services operations in North America by opening a new bioanalytical lab.  The initial investment will include a 2,500+ square-foot lab, set to be operational by Q3 2025. The lab will provide advanced analytical testing services for both small and large molecules, mirroring Ardena’s European capabilities in immunochemistry, LC-MS/MS, flow cytometry, and qPCR platforms. Ardena said the lab will lso offer enhanced support for global clinical trials programs.

Biosynth

  • Opened an expanded GMP bioconjugation facility at its existing Berlin site. The strategic expansion is intended to significantly enhance Biosynth’s specialized manufacturing capabilities in conjugate vaccines and conjugate drugs, activated PEGs, and polymer-based drug delivery excipients as part of its global manufacturing network.
  • Appointed former Lonza executive Marie Leblanc as Executive Vice President of Life Sciences, with commercial and strategic responsibility for Biosynth’s development and manufacturing services, as well as critical product supply, to life science customers across pharma, vaccines and research.

Charles River Laboratories

  • Does not break out revenue from CDMO activities, instead including them within its Manufacturing segment.
  • Signed a plasmid DNA CDMO agreement with Elly’s Team, a parent-led foundation focused on translating medical research into treatment for neurodevelopmental disorder with regression, abnormal movements, loss of speech, and seizures (NEDAMSS). As part of Charles River’s Cell and Gene Therapy (CGT) Accelerator Program (CAP), Elly’s Team accessed Charles River’s gene therapy CDMO capabilities and advisory services to manufacture critical starting materials for a Phase I clinical trial.

Culture Biosciences

  • Launched Stratyx™ 250, which according to the company is the first mobile, cloud-integrated bioreactor designed to deliver a 16% lower total cost per run compared to traditional benchtop bioreactors. According to the company, Stratyx™ 250 enables 25% faster development timelines, 30% improved scale-up success, and real-time process monitoring through its fully integrated Culture Console software.
  • Appointed Victor Bornsztejn as Senior Vice President of Commercial, where he has been overseeing the commercial direction of the company and leading the launch of StratyxTM

Curia Global

  • Expanding sterile fill-finish facility in Glasgow, Scotland by adding an integrated, isolator-based vial filling line and lyophilizer suitable for a broad range of drug product including highly potent capabilities, increasing GMP batch size up to 20,000 vials. The new capacity will also feature robotic, lossless filling technology situated within an isolator to allow filling speeds five times faster than current capabilities.
  • Investing $200 million toward ongoing, multi-year expansion project at Curia’s Albuquerque facility. Two isolated filling lines will add over 70,000 square feet to Albuquerque’s over 200,000-square-foot manufacturing space, creating significant Phase III clinical and commercial capacity, the company said. In Q3 2025, Curia expects to begin commissioning of a new high-speed vial line that includes two autoloaded freeze driers, automated vial inspection and labeling/packaging for 2R to 30R vials.

Fortis Life Sciences

  • Partnering with Avantor®, a global provider of mission-critical products and services for the life sciences and advanced technology industries, to expand availability of its reagents across North America. Fortis’ antibodies, enzymes, master mixes, nanoparticles, and viral vectors from Fortis portfolio companies are available through Avantor’s distribution network.
  • Launched the AbNano™ Anti-T-Cell VHH Library through its Abcore® brand, operating within Fortis’ Antibody Solutions (AbS) division. The first-in-class, naturally derived VHH library is designed for rapid identification of antibodies that bind to native T-cell surface proteins.

Northway Biotech

  • Launched strategic partnership with Diorasis Therapeutics (DTx) to establish a scalable cGMP production process for DTx’s lead AAV-based gene therapy candidate for open angle glaucoma.
  • Launched partnership with AATec Medical for manufacturing process development and analytical development of AATec’s lead product candidate ATL-105, an inhaled therapy based on recombinant alpha-1 antitrypsin (AAT) for non-cystic fibrosis bronchiectasis.

ProBio (subsidiary of GenScript Biotech) 

  • Opened its flagship Cell and Gene Therapy Center of Excellence at the Princeton West Innovation Campus in Hopewell, NJ. The 128,000 square-foot GMP facility is designed to manufacture plasmid DNA and viral vectors, including adeno-associated virus (AAV) and lentiviral vector (LVV) platforms.
  • Launched its GMP Plasmid DNA manufacturing service at its Hopewell, NJ, facility. The service is designed to guarantee delivery of ≥85% supercoiled clinical-grade plasmid DNA production from cell bank to batch release in a faster-than-standard three months.

SCTbio

  • Partnering with Oslo University Hospital to advance a next-generation CAR-T cell therapy targeting STEAP1, a tumor-associated antigen highly expressed in prostate cancer and Ewing sarcoma. SCTbio will provide GMP-grade gamma retroviral vectors to support production of genetically modified CAR-T cells for preclinical and early clinical studies. SCTbio will partner with plasmid manufacturer JAFRAL to source both research use only and GMP-grade plasmids.
  • Partnering with CCRM Nordic to provide end-to-end support for early-stage cell therapy companies, combining SCTbio’s expertise in cGMP manufacturing

    with CCRM Nordic’s infrastructure and analytical capabilities. The partnership will leverage CCRM Nordic’s future 3,000 square-meter (32,291 square-foot) labs for analytical and process development, with plans for a GMP facility to be established in 2026.

Simtra BioPharma Solutions

  • Purchased from Cook Group a 65-acre property (301 N. Curry Pike) near its existing manufacturing facility in Bloomington, IN, with more than 300,000 square feet of available space for expansion under-roof. Company said it evaluating a project to design and install manufacturing lines at the site, including its first U.S.-based commercial-scale capacity for oncology-focused injectable drug products.
  • Expanded its Halle (Westfalen), Germany facility by completing construction of a new production manufacturing building in June. Total production area now spans nearly 12,000 square meters (130,000 square feet) and employs 950 staffers. The 1,800+ square-meter (19,400+ square-foot) expanded facility will create 150 new jobs.

To view GEN‘s Top 10 Contract Development and Manufacturing Organizations 2025 click here.