DOWNSTREAM PROCESSING FEATURED ARTICLES

Cortex Biochem Awarded Patent
Cortex Biochem(TM) Inc., a global leader in developing magnetic particle technology and products used in genomic research and clinical diagnostics, announced it has received a U.S. patent for its MagaZorb(R) Nucleic Acid (DNA/RNA) Isolation and Purification System...

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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

  • 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. 

  • Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
  • Sani-Tech® Ultra White Paper

    For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. 

  • Metal Removal From Fine Chemical Products

    Metal contamination in various injectable or even oral medicines is a serious concern.

  • 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

DOWNSTREAM PROCESSING 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.

The VHP® TS1000™ Tri-Scale Sensor boosts VHP® VICTORY™ Biodecontamination Cycle efficiency and effectiveness of room and facility biodecontamination ensuring that hydrogen peroxide vapor sterilant is adequately distributed. 

Sani-Tech® offers a complete line of high-purity, non-metallic sanitary processing systems and related components, including tubing and fittings, valves, flow measurement components and sight gauges, and sanitary adapters, as well as fabrication equipment for field installation and small-scale bench-top systems for research and process development. 

All Hamilton General Use Housings/Armatures have an integrated electrode protection design to prevent possible damage of the electrode membrane due to solid components in the sample.

Freeze drying is a potentially damaging process, especially to labile materials such as proteins or living organisms. Depending on the product type damage can occur at various stages of the process including freezing, drying and heating.

Proyield Soy SE70M-UF is protein hydrolysate derived from soy protein concentrate by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Soy SE70M-UF has been ultrafiltered to reduce endotoxin.

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.

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.

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