DOWNSTREAM PROCESSING FEATURED ARTICLES

FDA Approves New Combination Vaccine That Protects Children Against Two Bacterial Diseases

The U.S. Food and Drug Administration recently approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Efficiency Test Of ReadyToProcess™ Columns

    ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).

  • Efficiencies Of Natural Convection In Passive Pallet Shippers

    Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick

  • 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.
  • 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.

  • Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess

    The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.

DOWNSTREAM PROCESSING PRODUCTS

Proyield Cotton CNE50M-UF is a protein hydrolysate derived from cottonseed by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Cotton CNE50M-UF has been ultrafiltered to reduce endotoxin.

CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.

CHO Feed 3 is a chemically-defined protein-free feed medium of non-animal origin. Using Irvine Scientific’s Rational Culture Media Design™ approach, this formulation has been developed to achieve high growth kinetics and product yield in fed-batch processes.

Sani-Tech® Ultra represents the next generation in ultra-pure platinum-cured silicone tubing. Features like ultra-low extractables and longer pump life were engineered into Ultra by the experienced materials scientists of Saint-Gobain Performance Plastics to meet the stringent requirements of the biopharmaceutical market.

SoftGrip pipettes routinely receive the highest user satisfaction score of 10 on 11 different aspects of a pipette, including plunger and eject forces, weight, diameter, and texture.

A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.

The APM is a next generation fluid management solution for single use process systems allowing you to modulate and control flow without having to use your fingers as the control valve.

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