Manufacturing, Drug Products

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

For rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.

FDA’s 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

A matrix of multi-functional cleanrooms can be adapted for launching products.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Pharmaceutical scientist association announces upcoming term’s board of directors.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

Early adopters are benefiting from lower costs and increased productivity.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

Single-use systems provide replaceable fluid paths.

Reliable, high-quality products require innovative analytics and production.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

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

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.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.