DOWNSTREAM PROCESSING FEATURED ARTICLES

NGM Enters Agreement With Janssen To Discover And Develop Novel Therapeutics For Diabetes

NGM Biopharmaceuticals, Inc. announced recently that it has signed a worldwide agreement with Janssen Pharmaceuticals, Inc. to discover and develop novel therapeutics for the potential treatment of Type 2 diabetes and other metabolic diseases.

  • Scientists Find A New Way To Boost Common Cancer Drugs

    Shutting down a specific pathway in cancer cells appears to improve the ability of common drugs to wipe those cells out, according to new research from scientists at Fox Chase Cancer Center, published in the January issue of Cancer Discovery.

  • Standardized Extractables Testing Advances Single Use Adoption

    The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.

  • Designer Bacteria May Lead To Better Vaccines

    Researchers at The University of Texas at Austin have developed a menu of 61 new strains of genetically engineered bacteria that may improve the efficacy of vaccines for diseases such as flu, pertussis, cholera and HPV.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

  • Important Parameters For Packing Nuvia HR-S Resin At Process Scale

    Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.

  • Improving Aggregate Removal From mAb Feed Using Cation Exchange Chromatography

    Researchers in the field of chromatography have required ever more sophisticated and selective methods for removing aggregates from the monomer.

  • Turning Data Into Information

    As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

  • Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  • Cultivation Of CHO Suspension Cells And SEAP Expression

    This application note describes the cultivation of CHO suspension cells in the wave-mixed Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5 L. 

DOWNSTREAM PROCESSING PRODUCTS

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines.

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.

The ReadyToProcess WAVE 25 rocker features integrated temperature sensors and load cells, designed for convenient handling and control of cell cultures up to 25 L. A filter heater is delivered with the system.

3M Purification's core filtration technologies address the most demanding applications in pharmaceutical processing for small molecule and active pharmaceutical ingredient (API) applications.

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.

LifeASSURE SP series sterilizing grade filters and capsules are validated for absolute bacteria retention and provide reliable sterile filtration performance.

A wide selection of ion exchange resin is available in various particle sizes, ionic forms, and purity ranges to offer a variety of purification solutions for process applications. Nuvia ion exchange resins are a family of best-in-class ion exchangers built with exceptionally high capacities and excellent purification capabilities, providing process developers more flexibility and higher productivity. The Macro-Prep are rigid macroporous hydrophilic resin meet the demands of process-scale applications. Chemically and mechanically stable, the resin operate well at low and medium pressures.

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