Industry News

Making CRLs public will help drug developers avoid common missteps, increase insight for healthcare decision making and ensure transparency for investors, said the agency.

The integration expands automation and scalability options for cell therapy process development, according to the companies.

The new facility at its headquarters in Foster City, California will expand biologics capabilities and support technology transfer for next-generation therapies.

With the designation, developers using IRO are expected to gain earlier and more frequent engagement with the agency throughout regulatory processes.

The new facility in Thousand Oaks will unite scientists and engineers to accelerate therapeutic discovery.

The contract with the unidentified company runs through 2030 and supports a Phase 3 program expanding into new indications.

The investment from Quebec government will expand sterile filling capacity and replace most existing equipment at the company’s Boucherville site.

The collaboration links donor material sourcing with GMP manufacturing for autologous and allogeneic therapies.

The Phase II expansion of Production Block 11 at the company’s Bidar, India flagship site makes it the largest reactor block at the location.

The new 75,000-square-foot facility will add large-scale solid- and liquid-phase synthesis capacity to support peptide API demand.

The platform combines physical models and real-time sensory data to improve anomaly detection and predictive maintenance.

The collaboration with the synthetic biology company supports Ottimo’s investigational new drug submission as a potential cancer treatment planned for late 2025.

The Commonwealth experienced a rare decline in jobs in 2024 amid funding constraints and federal uncertainty, according to the 2025 MassBio Industry Snapshot.

The 190,000-square-foot site in West Valley City, Utah is designed to manufacture more than 40 different radioisotopes and up to 12 radioisotopes simultaneously.

The 700,000-square-foot Holly Springs plant will add 400 manufacturing jobs and more than 1,500 construction jobs, with operations targeted for 2029.

As part of a licensing deal, the CDMO will produce and supply nucleic acid monomers and modified oligonucleotides to expand RNA therapeutics development.

The Snapdragon Chemistry facility expansion adds GMP capacity and supports multiple peptide synthesis approaches.

The Digital Pioneer Program combines automation and digital tools to streamline autologous cell therapy production.

The new 375,000-square-foot Mebane facility, which is a carbon neutral site, will produce up to 40 million pipette tips per week, according to the company.

The Sellersville site expansion will support production of NewAmsterdam Pharma’s investigational fixed-dose combination cholesterol therapy.

The New Jersey-based company will add a 160,000-square-foot facility at Fujifilm Biotechnologies’ Holly Springs campus, creating about 120 new jobs.

The review extension follows FDA observations at a former Catalent facility now owned by Novo Nordisk, which handles final preparation and packaging of Eylea HD.

The reduction affects staff at Catalent’s Harmans/BWI viral vector facility, which manufactures gene therapy drug substance and finished product.

The Chinese CRDMO attributed the results in the first half of 2025 to operational efficiency gains, technology platform expansion, and facility ramp-ups in Europe.

The UK-based CDMO will contribute formulation expertise to a project aimed at addressing the limitations of intramuscular vaccine administration.

The expansion adds aseptic lines for syringes and vials, formulation and R&D capacity, and commercial-scale packaging capabilities at its Brooksville, Florida site.

The Dundalk facility includes 6,000 liters of perfusion capacity and 48,000 liters of fed-batch capacity, making it a key hub in the Chinese CRDMO’s global network.

The $78 million investment will support large-scale GMP production, fill-finish, and advanced automation.

The new site in Hopewell will provide scalable, end-to-end adeno-associated virus production capabilities in a single U.S.-based location, according to the company.

The new 60,000-square-foot headquarters features cleanrooms, QC labs, and digital manufacturing systems to support clinical-to-commercial programs.