Manufacturing

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.

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.

Through the agreement, Foamix will have access to $20 million of financing to fund the commercial launches of the topical treatments.

Improving operator skills using flexible, online training benefits pharmaceutical tableting operations.

The transaction is anticipated to close by the end of 2019.

Advanced packaging requirements for parenteral drugs are being met with highly tailored solutions.

Ready-to-use components help compounders and manufacturers of small batches overcome economy-of-scale limitations in aseptic GMP manufacturing.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Optima Packaging explains its approach to process design.

Systems-based pharmaceutics case studies, challenges, and new uses were discussed at PSE’s Advanced Process Modeling Forum.

Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.

The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.

The increased capacity will enable the company to guarantee short production timelines.

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.