Manufacturing

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Industry experts debate the pros and cons of “going bigger” than the 2000-L industry norm in a single vessel.

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

The expansion plans to build upon the company’s high potent drug manufacturing and development capabilities, including both clinical and commercial supply.

Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.

The expansion will enhance the company’s specialty drug product capabilities.

The latest advances in upstream technologies include single-use equipment and a protein analyzer for titer monitoring, as well as new plasmid DNA manufacturing capability.

The new 50,000-square-foot facility will create 200 new jobs and accelerate commercialization of gene and cell therapies.

The acquisition aids in the expansion of the Astellas Focus Area approach, which involves the creation of medicines for diseases with high unmet medical needs by identifying combinations of biology, therapeutic modality and technology based on emerging science.

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.

Biopharma company, Zelluna Immunotherapy, and clinical stage biotech, Glycostem Therapeutics, have entered into a partnership focused on the development and manufacture of allogeneic T-cell receptor guided Natural Killer cell therapies for the treatment of cancer.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.

The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.