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.
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.
This white paper demonstrates how the Waters Regulated Bioanalysis System Solution, built upon the UNIFI Scientific Information System, meets the converging needs of investigators, analysts, managers, and QA and IT professional by uniting best-in-class sample preparation, UPLC/MS technology, software. and supports services in a single platform purpose-built for quantitative bioanalysis. It illustrates how the platform integrated into the workflow of the bioanalytical laboratory in a secure and complaint manner, and enables better decision making within the drug development lifecycle of a pharmaceutical organization and its respective partners.
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SciLog, Inc., the world’s first and largest designer and manufacturer of single-use bioprocessing systems and pre-calibrated sensors, today announced its purchase of and relocation to a new and larger corporate headquarters in Madison, Wis.
The new facility will enable SciLog to address the rapid growth in global demand for its bioprocessing products and services through expanded manufacturing, customer service and support operations. The company said its supply chain management team has grown as part of the expansion.
GE Healthcare, a unit of GE announced today it has reached an agreement to acquire Xcellerex, Inc. a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry. The acquisition of Xcellerex will allow GE Healthcare to expand its offering of products and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines. The strong strategic fit between the two companies, combined with expanded capabilities in product development and marketing, will offer significant customer benefits. Financial terms were not disclosed.
Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. Traditional approaches, like polling subject matter experts on the manufacturing floor or analyzing resource utilization rates, simply do not work. Worse still, the answers these approaches provide are often costly and can actually be detrimental to run rates and other critical KPIs.
CHICAGO, Illinois, February 16, 2012 - The Enrollment Metrix Forum recently completed an analysis of how the biopharmaceutical industry is using performance metrics in the most time consuming and expensive portion of the clinical trials process -- enrollment. The analysis was based on data of 11 companies: Amgen, AZ, Bayer, BMS, J&J, Lilly, Merck Research Laboratories, Pfizer, Roche, Shire, UCB.
Biopharma manufacturers are increasingly satisfied with their suppliers of single-use devices, but that satisfaction is sometimes misplaced on less-critical attributes.
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