DOWNSTREAM PROCESSING FEATURED ARTICLES

Hamilton Robotics Launches Highly Flexible PCR Setup Workstation

Hamilton Robotics introduces the PCR setup STARlet, the first automated liquid handling system flexible enough to accommodate any DNA amplification reagent kit, from simple setups and small budgets to highly demanding workflows.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Avoiding Drug Shortages With Microbial Detection

    Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

  • 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. 

  • Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

  • 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.

  • A Purification Strategy For Clinical-Grade Monoclonal Antibody

    mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture. 

  • Examining Column Reproducibility During Method Development In Clinical Labs

    In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

DOWNSTREAM PROCESSING PRODUCTS

A floor-model preparative ultracentrifuge possessing all of the attributes of the Beckman Coulter entry-level model XE, the Optima XPN enhancements simplifies use, optimizes control and security, and increases productivity.

Choose from ten fixed volume SoftGrip pipettes covering 0.2 µL to 1 mL. All pipettes have color-coded plunger buttons and labels for easy volume identification.

Sterilizing grade 0.04um, 0.1um, 0.2um hydrophilic PES membrane filters plus other micron ratings. Single layer or double layer PES and with optional prefilter layers to extend on-stream life. Gamma compatible and suitable PVDF alternative. 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. 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.

With the Eppendorf BioSpectrometer basic, measurements can be executed in the UV and Vis range from 200 nm to 830 nm. The freely selectable wavelengths offer you maximum flexibility during these procedures.

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 Pyros Kinetix® Flex is an optical tube reader that runs both chromogenic and turbidimetric assays in compliance with the USP, EP, and JP bacterial endotoxin test chapters.

Polyethylene (PE) and PTFE hydrophobic membranes for economical air / gas and vent filtration. Virus, bacteria and spore retentive. PE is gamma stable and will substitute PVDF. Retention ratings from 0.01um in gas applications or 0.1um in liquid applications, to 10um.

PES, Nylon or Cellulose Acetate hydrophilic membranes provide performance improvements over other membrane types like PVDF. Microbially retentive micron ratings from 0.04um, 0.1um and 0.2um to prefilter ratings 0.45um, 0.65um and up to 1.2um.

ZenPure designs, mold-manufactures and injects its own filter components. Engineering, product development and filter production under ISO standards facilitate full quality audit and traceability to meet the highest industry standards. Validation support documentation is available for appropriate products.

The Agilent 2100 Bioanalyzer is a microfluidics-based platform for sizing, quantification and quality control of DNA, RNA, proteins and cells on a single platform. Results are delivered within 30-40 minutes in automated, high quality digital data.

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