Manufacturing, Biologic Drugs

A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The company’s Quantum peristaltic pump uses a patented single-use cartridge technology and is applicable to downstream bioprocessing.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

ITT Engineered Valves presented its new EnviZion hygienic valve technology at INTERPHEX 2019 in New York City.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

Think ahead to production requirements when planning strategies in early development of gene and cell therapies.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

Alcami Biologics formed to meet market demands for biological drug development services.

The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.