Manufacturing

Articles

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

Leveraging Single-Use Learnings in Fill-Finish Operations

FDA updates guidance to reflect advances in technology.

FDA Reissues Bioanalytical Method Validation Guidance

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Best Practices for Restricted Access Barrier Systems in Aseptic Manufacturing

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

Isolator Technology for Aseptic Filling of High Potent Products

Shimadzu's LCMS-8040 combines newly improved ion optics and collision cell technology with proprietary ultrafast technologies.

The world's fastest LCMS/MS tandem mass spectrometer

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Pre-use Filter-Integrity Testing: To Test or Not To Test?

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Recycling is becoming a viable option for disposal of single-use systems.

Waste Management of Disposable Biopharmaceutical-Manufacturing Components

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Gauging Biopharm Outsourcing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

35th Anniversary Special: The Today and Tomorrow of Process Analytical Technology

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.