Manufacturing, Biologics

Valve design and materials affect performance and cost to maintain.

Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.

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

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

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

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

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.

A look at the Univercells' NevoLine bio manufacturing platform, which incorporates principles of automated and continuous bioprocessing.

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.

Drug makers continue to explore innovative ways to develop antibody-drug conjugates based on their unique potential to neutralize cancer cells.

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

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

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.

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

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.

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.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

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.