Manufacturing

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

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.

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 technology is set to heighten the company’s GPEx expression platform through the utilization of a glutamine synthase knock-out Chinese hamster ovary cell line.

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.

Schott will combine its adaptiQ platform with West’s Ready Pack system.

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.

The new Javené, France-based facility is expected to increase the company’s production capacity of injectable grade sodium hyaluronate obtained by fermentation by 2.5 times.

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.

A second lawsuit has been filed by Centrient Pharmaceuticals India in the High Court of Delhi in New Delhi against Dalas Biotech for patent infringement.

The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

Under the agreement, gene and cell therapy companies can go directly to Aldevron for NTC’s technology without acquiring a license from NTC.

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.