Industry News

The deal adds packaging, labeling, and Qualified Person release services to support integrated supply chain operations across the U.S. and Europe.

The collaboration establishes a U.S.-Asia-Pacific manufacturing network to support regional production, streamline tech transfer, and accelerate global clinical supply.

Bayer, Eli Lilly, Sanofi, and others recognized for modular design, digitalization, and supply chain integration in manufacturing operations.

The CDMO’s service provides pre-cleaned and sterilized single-use assemblies to reduce contamination risk and streamline validation in bioprocessing operations.

The company’s Viralgen facility will supply high-purity AAV drug product using a large-scale suspension process to support clinical manufacturing and trial expansion.

The Breda facility provides hands-on training and process support for upstream and downstream technologies used in biopharma manufacturing operations.

The collaboration links site-specific conjugation technology with GMP manufacturing to support tech transfer, scale-up, and commercial production of ADCs.

The project is being touted as Africa’s first end-to-end multi-vaccine manufacturing site, with capacity of up to 40 million doses annually.

The Somerset facility adds LC-MS/MS, immunochemistry, and sample storage capabilities to support bioanalysis for preclinical and clinical programs.

The companies said the NMR-based process analytical technology approach could improve scalability and reduce the complexity of RNA vaccine manufacturing.

A new high-volume filling line and GMP facility aim to support syringe and cartridge production with advanced isolator-based sterile processing.

The capacity additions and facility upgrades aim to support early-stage manufacturing, aseptic processing, and supply of clinical trial materials.

The CDMO added cleanrooms, quality control labs, and digital systems to support commercial-scale production, validation, and release of cell therapy products.

The collaboration integrates radiopharma manufacturing with antibody platforms to support scalable production and development of targeted oncology therapies.

The service integrates upstream and downstream processes to reduce timelines to GMP production for eligible cell and gene therapy programs.

The St. Louis site adds integrated GMP-aligned microbial and ICH-compliant stability testing to improve turnaround times and data visibility, according to the company.

The agreement grants rights to develop multiple cell therapy candidates using a cGMP-compliant induced pluripotent stem cell line.

The Hangzhou facility achieved licensure just two months after qualification and will hold a total capacity of 172,000 liters upon completion, according to the announcement.

The engineering campaign validated the company’s expanded mammalian manufacturing suites for late-stage and commercial biologics production at its San Diego site.

The agreement supports domestic manufacturing, procurement, and expanded development of Fetroja for biothreat-related infections.

The rebranding combines the company’s active pharmaceutical ingredient, drug product and supply capabilities under one trading name.

The CDMO cited lower greenhouse gas emissions, reduced water use and continued investment in sustainable manufacturing operations.

The reorganization establishes a dedicated contract development and manufacturing organization subsidiary while streamlining its therapeutics development business.

The agreement is intended to accelerate an IND filing for Akari’s lead antibody-drug conjugate program targeting metastatic urothelial cancer by late 2026.

The rating reflects performance in hazardous chemical management, public health contributions, human capital development, and board oversight.

The Toa Baja facility is designed to the same standards as the company’s existing Taichung, Taiwan manufacturing site and is to begin operations in 2027.

The agreement covers the production of cGMP clinical materials for Anixa Biosciences’ vaccine candidate.

The functionally closed system is designed to reduce manual intervention and improve batch-to-batch consistency in cell therapy formulation and filling workflows.

The financing supports additional radiopharmaceutical manufacturing and medical isotope production at the company’s Indiana campus.

The platform is designed to help biologics developers accelerate time to clinic, while supporting scalability and regulatory compliance, according to the company.