DOWNSTREAM PROCESSING FEATURED ARTICLES

CPC NEW Combination Sterile Connections For Single-Use Applications

Gain insight into why combination connections are used in single-use bioprocessing and guidance on how single-use systems can be designed to integrate the combination connectors.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • Mammalian Virus Purification Using Ceramic Hydroxyapatite

    Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We  propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

  • Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

  • 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).

  • 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.

  • Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
  • Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.

DOWNSTREAM PROCESSING PRODUCTS

These new OEM cameras from Hamamatsu feature an advanced scientific CMOS (sCMOS) image sensor capable of high resolution, fast frame rates, and low noise simultaneously. With their small size, board-level design, and simple, low-cost integration, these OEM cameras are ideal for imaging in life science, failure analysis, and semiconductor inspection.

Sterilizing grade 0.04um, 0.1um, 0.2um hydrophilic PES membrane filters plus other micron ratings. Single layer or double layer PES and with optional prefilter layers to extend on-stream life. Gamma compatible and suitable PVDF alternative. 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. 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.

With the Eppendorf BioSpectrometer basic, measurements can be executed in the UV and Vis range from 200 nm to 830 nm. The freely selectable wavelengths offer you maximum flexibility during these procedures.

Cross- Flow Filtration mineral (inorganic) membranes and systems for bioprocessing and separation of biomolecules (e.g. monoclonal antibodies); especially for UF/DF filtration step in downstream processing.

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.

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.

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

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

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