Manufacturing, Biologic Drugs

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work.

The EnviZion hygienic diaphragm valve from ITT Engineered Valves allows for simplified installation and maintenance.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.

The expansion will increase the company’s single-use capacity to meet growing demand.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

The partnership will focus on the commercialization of inducible promoters to improve biomanufacturing.

The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.

Vibalogics has increased its single-use bioreactor and purification capacity with a new manufacturing for its specialist oncolytic virus and viral vector manufacturing services as a result of a growth in demand.

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.