May 4, 2012 – 3M Purification Inc. has expanded its portfolio of the LifeASSURE™ PDA Series of sterilizing grade polyethersulfone (PES) membrane filters. The two new product lines – gamma compatible and sterile capsule filters – incorporate two layers of asymmetric polyethersulfone membrane that provides extremely high contaminant capacity, fast flow rates and reliable sterilizing grade filtration performance.

May 4, 2012 – 3M Purification Inc. has expanded its portfolio of Encapsulated Zeta Plus™ single-use depth filtration capsules. The two new product lines – Zeta Plus Scale-up Capsule Filters and new single-layer media grades for Zeta Plus Encapsulated capsules – are designed with our industry leading Zeta Plus depth filter media, designed for applications in the bio-pharmaceutical industry including cell culture clarification, downstream process protection, virus, DNA and lipid reduction, and host cell protein (HCP), protein aggregate, endotoxin and anti-foaming agent removal.

Introduction
Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities, is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). Cell culture-based potency assays are often the preferred format for determining biological activity since they measure the physiological response elicited by the product and can generate results within a relatively short period of time unlike typical animal-based assays. Cell-based potency assays are also often the only functional assays used for product release and stability programs. Other uses of cell-based assays include qualification of internal reference standards; characterization of process intermediates, formulations and degradation products; and support of changes in the product production process.