Facility Design and Engineering

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

The API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

The clinical-stage biopharmaceutical company has announced the opening of a new gene therapy manufacturing facility in Modiin, Israel, which is anticipated to be the production site of the company’s lead cancer drug candidate.

The biotechnology company has officially opened its new Michigan research and production center for the production of spider silk-based fibers, as well as for the company’s polymer research and development program.

The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.

Water shortages, testing expenses, and effluent treatment are important issues for pharma manufacturers.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Cytel, a biometrics CRO and clinical trial software provider, announced that it will be adding a new location for clinical development in Basel, Switzerland.

Lonza has announced plans to acquire a clinical-stage mammalian manufacturing facility in the United States from Shire.

The iCON brand aims to offer flexible, rapidly deployable systems for biopharmaceutical manufacturing.

Virgin Atlantic Cargo and Delta Cargo have opened a new Pharma Zone at their joint facility at London Heathrow Airport for the handling and storage of pharmaceutical shipments.

Kraig Biocraft Laboratories, a developer of spider silk-based fibers, will open a new facility in Michigan to combine its research and production efforts.

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company’s product and water testing businesses in the UK.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.2 analytical laboratory.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.