Manufacturing

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Sanofi’s acquisition will grant access to Amunix's promising immuno-oncology pipeline.

Amgen and Syngene International have extended their research collaboration to 2026.

Genezen has opened its new process development and analytical lab for viral vector production.

Pfizer invested $68.5 million in a facility in Durham, NC.

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

SKAN’s new Cellana isolator is designed for GMP manufacturing of ATMPs.

Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.

Leucid Bio will collaborate with Lonza to use Lonza’s Cocoon Platform for clinical and commercial manufacturing of CAR T cells for Leucid’s lead candidate.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

A new Cytiva FlexFactory platform will be installed at Taiyo Pharma Tech’s site in Osaka, Japan.

Fujifilm’s new cell culture media manufacturing facility in the Netherlands has officially opened.

The additions to Crown Bioscience’s UK facility will increase and expand the company’s current in-vivo offering.

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Moderna’s agreement with the UK government includes 29 million COVID-19 vaccine doses for delivery in 2022 and 31 million doses for delivery in 2023.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.