Industry News

The CDMO will provide access to up to 50 million vaccine doses during a future pandemic.

The agreement covers a preclinical trispecific candidate for B-cell mediated autoimmune diseases.

Manufacturing is expected to begin in 2026 at OXB’s sites in Oxford, UK, and Durham, North Carolina.

The transaction provides infrastructure to broaden Nanologica’s product portfolio beyond silica-based purification media, according to the announcement.

The CDMO completed development, scale-up, and commercialization of the delivery system across two sites within five months.

The authorization for the U.S.-headquartered CDMO allows biologics and biosimilars made at the site to be commercialized in the South American country.

The collaboration expands automated cell therapy manufacturing beyond T cells into hematopoietic stem cells.

Manufacturing of ExpreS2ion Biotechnologies’ Nipah vaccine program is scheduled to begin in the first quarter of 2026 under an EU-funded development program.

The tool is designed to reduce the time and resources required to convert paper batch records into digital workflows, according to the company.

The software is intended to support earlier decision-making in solid-form selection during drug substance development, the company said.

Construction of the Saarland facility is scheduled to begin in 2026, with operations expected to start in 2031.

The collaboration covers preclinical pharmacology studies and clinical supply to support planned IND filings in China and the United States.

The financing will support global deployment of the company’s integrated, GMP-ready manufacturing facilities in Europe, Japan, and the U.S.

The move follows the sale of Noramco’s API assets and positions Halo for expanded sterile manufacturing capacity, according to the company.

The collaboration will evaluate GMP-ready robotic systems for scalable, high-throughput cell therapy production.

The $30 million expansion adds 2,000-liter single-use GMP capacity to support late-stage and commercial biologics programs.

The agreement centers on CMC execution and GMP manufacturing support for multiple clinical-stage fusion protein programs.

Manufactured under cGMP conditions, the additions include low-endotoxin and enzyme-free formulations for laboratories and manufacturing use, the company said.

The investment supports compliant manufacturing of non-bacterial beta-lactam medicines amid stricter cross-contamination controls.

The Grissom Aeroplex expansion in Bunker Hill adds GMP capacity for high-volume therapeutic and diagnostic production.

The collaboration, which includes Merck Sharp & Dohme and Hilleman Laboratories, will focus on improving process yield and storage to support scalable vaccine production.

The agreement covers clinical and commercial manufacturing support for Atsena’s inherited retinal disease programs.

The robotic-operated cell processing system is designed to reduce manual intervention while maintaining existing biological workflows, according to the companies.

The collaboration supports early-stage AAV development for a rare inherited disorder linked to phosphate regulation.

The multi-year agreement targets orphan and niche therapeutic active pharmaceutical ingredients for regulated and semi-regulated markets.

The new facility in Durham, North Carolina will support expanded analytical and development services for biologics and other complex therapeutics.

The expanded agreement between BMS and the Indian CRDMO broadens integrated discovery, development, and manufacturing services across the drug lifecycle.

The investment adds cold chain storage, syringe and device assembly, as well as GMP packaging capacity in Belgium and the Netherlands.

The Apex, North Carolina facility will operate as an FDA-registered 503B site focused on domestic production of shortage-listed generic injectables.

The agreement aims to integrate affinity-based cell isolation into an automated system to support faster, scalable T-cell processing.