DOWNSTREAM PROCESSING FEATURED ARTICLES

Refine Technology And Gallus BioPharmaceuticals To Collaborate On Continuous BioManufacturing

Refine Technology, LLC (Refine), the developer and worldwide supplier to the biotech industry of the ATF™ System, a best-in-class cell retention device, and Gallus BioPharmaceuticals, LLC (Gallus), the industry leading contract bulk biopharmaceuticals manufacturer, today announced a collaboration to optimize continuous cell culture processes.

 

  • Lpath Receives First U.S. Patent For Anti-LPA Antibody, Lpathomab

    Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, received official notification from the U.S. Patent and Trademark Office (USPTO) that it has been issued a key patent protecting Lpathomab™, a monoclonal antibody against lysophosphatidic acid (LPA).

  • Announcing High Quality Borosilicate Glass Centrifuge Tubes Chemists are finding the optimal centrifuge tubes they need at Kimble Chase, the largest manufacturer of laboratory glassware products in the world.
  • Roche Receives FDA Clearance For Herpes Simplex Virus Type 1 And 2 Tests

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. 

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library

    Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.

  • A Disposable Valve For Process Chromatography

    This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials. 

  • The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems

    Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.

  • Comparing The Automated Pipetting To Volumetric Glassware And Air Displacement Pipettes

    Analytical sample preparation is used in many industries such as forensics, environmental chemistry, mining, beer and wine fermentation and many others. Concentrated samples are diluted and analyzed via High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, and/or Inductively Coupled Plasma Spectroscopy to name a few. Traditionally these samples are prepared using volumetric glassware, syringes and/or pipettes.

  • Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
  • Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action

    Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
    therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777.

DOWNSTREAM PROCESSING PRODUCTS

Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.

Amsphere™ A3 is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing. With high capacity resin, Amsphere™ A3 has an overall improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime.

These new OEM cameras from Hamamatsu feature an advanced scientific CMOS (sCMOS) image sensor capable of high resolution, fast frame rates, and low noise simultaneously. With their small size, board-level design, and simple, low-cost integration, these OEM cameras are ideal for imaging in life science, failure analysis, and semiconductor inspection.

PureFlo hydrophobic polyethylene (PE) membrane filters, gamma compatible and ideal alternative to PVDF. Mold injected capsules with multiple inlet / outlet options including sanitary ‘T’ clamps, hose barbs, quick sanitary connectors, elbows and threads. Almost any combination of connecting inlet or outlet is possible with over 30 options. High gas flow at low differential pressure due to encapsulation geometries and polyethylene (PE) membrane. Full validation supporting documents are available. Ideal for tube sets and hook up to bioreactors, fermenters, biocontainer, biobags, wave bags or single use fermenters.

ZenPure’s in-company mold design and injection capabilities, filter production and quality assurance facilitate manufacturing audit and product traceability that meet the highest industry standards.

High volume labs require simple, durable solutions to their centrifugation needs. Beckman Coulter’s Allegra® Series general purpose, benchtop centrifuges serve the needs of these labs by saving time, offering ease-of-use, and providing reliable design for endurance under the most exacting standards.

Proyield Wheat WGE80M-UF is a protein hydrolysate derived from wheat gluten protein by enzymatic hydrolysis.

Capto S, Capto Q and Capto DEAE are, respectively, strong cation, strong anion and weak anion exchange media for packed bed chromatography that increase speed and throughput in capture and intermediate purification.

Hydrophilic or hydrophobic membrane filter capsules and cartridges for sterilizing liquid or gas. More than 20 different inlet / outlet connections, with or without vents and drains. SIP / Autoclavable. Specify when gamma stability is required.

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.

DOWNSTREAM PROCESSING INDUSTRY NEWS