Manufacturing

Articles

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing. 

Raman Spectroscopy System Allows On-line Process Measurement

Birte Kleindienst is junior product manager, viral clearance, at Sartorius Stedim Biotech.

Anika Manzke is product manager, viral clearance at Sartorius Stedim Biotech.

Peter Kosiol is scientist, Membrane Development atSartorius Stedim Biotech

Requirements for virus filtration must be considered in developing continuous downstream processes. 

Continuous Processing: Challenges and Opportunities of Virus Filtration

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

Proper Process Development and Drug Shortages

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells. 

Orchard Therapeutics Announces New Gene Therapy Manufacturing Facility

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.

Lonza to Establish Strategic Chinese Biomanufacturing Base

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

GSK and TESARO Reach Acquisition Agreement

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.

Tosoh Bioscience Moves to Acquire Semba Biosciences

Mark Witcher is senior consultant at Brevitas Consulting, witchermf@aol.com

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.

How FDA’s 21st Century Goals Can Be Realized by Using a Multi-Purpose Manufacturing Facility

GE’s new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification. 

GE Healthcare Opens Biotechnology Manufacturing Center in UK

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

Manufacturing, Biologic Drugs