Manufacturing

Articles

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Single-use Purification Media Improves Efficiency

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Biotage Launches Accelerated Chromatographic Isolation

Mark Wagner is purification technology and business development specialist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Jeffrey Shumway is associate director, bioavailability enhancement at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Juan Castano is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Claire Scanlan is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Ruta Waghmare is group leader, process development sciences at Millipore Corporation, Billerica, MA 01821.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody Fragments

Sean Milmo is a freelance writer based in Essex, UK.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

Early Communication with Regulators is Essential for SMEs

PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.

PSL Develops Microsphere Refiner for Formulation of Microspheres

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?

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

Evaluating Impurities in Drugs (Part III of III)

How to use geographic diversification and legacy technology transfers to avoid product shortages.

Managing Product Supply Risks

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Shipping with the Enemy?

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

Manufacturing, Separation and Purification