DOWNSTREAM PROCESSING FEATURED ARTICLES

FDA Reports Conditions Observed At New England Compounding Center Facility

Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

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From the leaders in microplate washing, BioTek introduces the world’s first deep well microplate washer that aspirates and dispenses into 96- and 384-well plates ≤50 mm in height.
Agilent's GeneSpring GX software provides powerful, accessible statistical tools for fast visualization and analysis of transcriptomics, genomics, proteomics and metabolomics data.

Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.

Proyield Soy SE50MAF-UF is a protein hydrolysate derived from soy protein by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Soy SE50MAF-UF has been ultrafiltered to reduce endotoxin.
Proyield Soy SE70M-UF is protein hydrolysate derived from soy protein concentrate by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Soy SE70M-UF has been ultrafiltered to reduce endotoxin.

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

The ARTeSYN DRV is designed to be a drop in replacement for your existing diaphragm valves, but with an easy to remove and replace flow through liner.

ReadyToProcess ULTA normal flow filter capsules are single-use filters designed for laboratory through process scale applications. Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.

DOWNSTREAM PROCESSING MULTIMEDIA

Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.

Beckman Coulter's Randall Lockner, marketing manager for centrifugation, explains the highlights of the floor model ultracentrifuge, the Optima X Series.

Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.

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