Manufacturing, Biologic Drugs

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

Suppliers address complex supply chains for global biopharmaceutical manufacturing using disposable components.

The company will invest an additional $60 million to expand its manufacturing facility in Durham County, NC.

Ireland’s National Institute for Bioprocessing Research and Training received funding from the Science Foundation Ireland’s Technology Innovation Development Award program for monoclonal antibody research.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

MilliporeSigma’s use of modified amino acids can simplify the fed-batch process in biomanufacturing.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.

The companies will collaborate to improve the manufacturability for two of Sanofi’s biotherapeutics.

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

Requirements for virus filtration must be considered in developing continuous downstream processes.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.