Manufacturing

Kite, a Gilead company, announced plans to build a new facility for the development and manufacturing of the starting material for the production of cell therapies, viral vectors.

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

TaskMate Robotic Systems from ESS Technologies with Fanuc America’s robots create an ultra-compact robotic cell that integrates with cartoners, case packers, and monoblock filler/cappers for collation and machine loading and unloading.

Omega Design’s auto-indexing machine dispenses canister desiccants into a wide range of containers for pharmaceutical and nutraceutical applications.

The expansion of Lonza’s Tampa site includes development and manufacturing capabilities for oral solid-dose drugs.

GSK announced the opening of its new manufacturing facilities in Singapore after a $130-million investment.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.

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

Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

New testing equipment for seal integrity of pharmaceutical packaging improves accuracy and flexibility.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.