Facility Design and Engineering

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

How warehouse execution systems can help in case of a drug recall.

The pharmaceutical industry is adopting Industry 4.0 and emerging technologies to improve product quality and manufacturing efficiency.

The Visiocover from GEA is a transparent sanitary cover for visual inspection of and process access to non-sticky-powder processes.

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.

With minimal damage to its manufacturing plant in Humacao, Puerto Rico, Colorcon has been able to restore full operations.

JLL, a real estate and investment management firm, recently released a new report on three trends shaping labs for the future of life sciences R&D.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.