Manufacturing

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

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

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

FDA is moving to shift industry away from step-wise batch production.

To achieve further cost reductions in biosimilar manufacturing, a move away from traditional models is necessary.

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.

Technical advances in process understanding and control must be accompanied by a change in mindset.

Getting the science right helps biopharma startups overcome development and commercialization challenges.

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.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

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 companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.

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.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

A properly designed validation program will detect variation and ensure control based on process risk.

A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.