DOWNSTREAM PROCESSING FEATURED ARTICLES

The Medicines Company And Bristol-Myers Squibb Begin Global Alliance For Recothrom®

The Medicines Company (NASDAQ: MDCO) announced today that the global license and two-year collaboration for Recothrom®, a recombinant thrombin approved by the U.S.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Determination Of kLa Values Of Single-Use Bioreactors

    Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

  • 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).

  • Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance

    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).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

  • 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.

  • SciLog - Creating Advanced Biotech Equipment With Mettler Toledo For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
  • Top 10 Considerations When Selecting An Isolator Supplier

    While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

DOWNSTREAM PROCESSING PRODUCTS

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.

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.

Our syringes are handmade with an unmatched attention to detail. The manufacturing process and quality assurance procedures ensure that every syringe we sell will provide superior accuracy and precision as well as cycle life.

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.

ARTeSYN arterial process valves can be arranged in a multitude of orientations. They can be arranged with individual straight through valves for quick assembly and break down or in multi-valve arrays to facilitate even the lowest hold up volume requirements.

Hydrophilic media and depth filters. Cellulosic, Diatomaceous earth + cellulose, GF, polyproylene and nano fiber disposable capsules or cartridges. For clarification, prefiltration or to protect columns. Many different inlet / outlet connections, with or without vents and drains. SIP / Autoclavable. Specify when gamma stability is required.

This is an exciting platform technology for cell cultivation. It is a highly versatile process which permits great increases in cell and product concentrations as compared to Fed Batch processing.

Resin are designed specifically for intermediate purification steps that remove host-cell contaminants from partially purified targets using strong or weak hydrophobic interactions. Methacrylate-based beads for protein and nucleic acid purification using hydrophobic interactions are available for purifying compounds that have weak or strong hydrophobic regions.

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