DOWNSTREAM PROCESSING FEATURED ARTICLES

extractables in single-use 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.

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.

  • Metal Removal From Fine Chemical Products

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

  • Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action

    Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
    therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777.

  • Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers

    Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager

  • 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. 

  • Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media

    CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.

DOWNSTREAM PROCESSING PRODUCTS

Our upstream process equipment including bioreactors, roller culture equipment and incubators. Small scale consumables and glassware contained in this section include, staining ware, tissue grinders, spinner flasks, and magnetic stirrers.

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.

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.

Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.

The SPRIworks Fragment Library Systems have built-in size selection and prepare fragment libraries for all three major next generation sequencing platforms. SPRIworks Systems simplify and automate fragment library construction for the Illumina Genome Analyzers, Roche GS FLX DNA Sequencer and Life Technologies SOLiD Sequencers.

The SoftGrip pipette and Hamiton AdvanTip Precision Pipette Tips create a liquid handling system designed for optimal performance. Ensure you are getting the Hamilton accuracy and precision advantage by using only Hamilton AdvanTip Precision Pipette Tips.

The QAII Station has been designed to ensure each tested dissolution apparatus conforms with mechanical specifications.

Conductivity sensors measure the ability of a solution to conduct a current. The higher the concentration of ions in the solution, the higher the conductivity, which is measured in microSiemens (mS).

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