DOWNSTREAM PROCESSING FEATURED ARTICLES

Advion Announces Full Integration With Agilent Technologies Liquid Chromatography Systems

Advion, Inc., a leading life sciences Systems and Consumables developer, announces that its expression compact mass spectrometer (CMS) is now fully integrated with Agilent Technologies’ full range of HPLC and (U)HPLC liquid chromatography systems.

  • How Hepatitis C Invades The Body

    Researchers at the University of Colorado School of Medicine have figured out intimate details of how the hepatitis C virus takes over an invaded cell, a breakthrough that could point to way for new treatments for the virus.

  • 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.

  • 3M Launches Large-Scale, Single-Use, Multi-Round Depth Filtration System

    3M expanded its portfolio of Encapsulated Zeta Plus™ single-use depth filtration products to include our Model# 16EZC Multi-Round Holder.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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.

  • Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers

    Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.

  • CD69 Expression On Activated Lymphocytes Is Stable In Streck's Cyto-Chex® BCT

    The purpose of this study was to determine if the activation marker, CD69, is preserved and stable in whole blood samples collected in Cyto-Chex® BCT. Previous studies have demonstrated CD marker stability of whole blood samples collected in Cyto-Chex BCT for up to 7 days when stored at room temperature (18-22°C).  By Jodi Alt, Ph.D

  • 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. 

  • Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities

    The following application note illustrates how the DASbox Mini Bioreactor System combined with the BioBLU 0.3c single-use vessels supports bioprocess development in human cell culture.

  • 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.

DOWNSTREAM PROCESSING PRODUCTS

Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.

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 DoverPac® Bag In/Bag Out (BIBO) containment system is a family of contained transfer designs for multiple processes. The primary components for this validated operation consist of multiple groove canisters, docking interface hardware, and softgoods in either continuous liner form or discreet liners.

Magnosphere™ is a superparamagnetic particle for in vitro diagnostics and bio research applications.

Protein A based affinity chromatography is the industry standard for the capture of monoclonal antibodies (MAbs) in downstream processing.
The CESI 8000 High Performance Separation-ESI Module is designed for mass spectrometry applications that analyze charged and polar molecules. Thanks to its robust OptiMS technology, the advantages of Capillary Electrophoresis are now delivered to the mass spectrometer without dilution or disturbance.

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.

The Avanti J-30I High-Performance Centrifuge System gives you the fastest separations possible - in the shortest amount of time. Swinging-bucket and fixed-angle rotors provide maximum separation forces in excess of 100,000 x g at speeds up to 30,000 rpm.

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