DOWNSTREAM PROCESSING FEATURED ARTICLES

Roche Receives FDA Clearance For Herpes Simplex Virus Type 1 And 2 Tests

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. 

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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.

  • Single-Use Connections Advance Aseptic Processing

    John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.

  • Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

  • 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.

  • Biomanufacturing Flexibility

    This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.

  • Selecting The Optimal Resins For Endotoxin Depletion In Process Purification

    A guide to effectively remove endotoxins with versatile process resins.

DOWNSTREAM PROCESSING PRODUCTS

Proyield Soy SE50MAF-UF is a protein hydrolysate derived from soy protein by enzymatic hydrolysis. The enzymes used for digestion are from non-animal sources. Proyield Soy SE50MAF-UF has been ultrafiltered to reduce endotoxin.
The SDR SensorDish® Reader is a small 24-channel reader for non-invasive detection of oxygen and pH in disposable 24- or 6-well multidishes. The multidishes contain a sensor spot at the bottom of each well. They are read out non-invasively and non-destructively through the transparent bottom of the multidishes by the SensorDish® Reader placed below them.

Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications. WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.

A floor-model preparative ultracentrifuge possessing all of the attributes of the Beckman Coulter entry-level model XE, the Optima XPN enhancements simplifies use, optimizes control and security, and increases productivity.

BalanCD® CHO Feed 2 is a chemically-defined protein-free feed medium designed to be added as a fed-batch supplement to promote cell growth and increase process yields of antibodies and recombinant proteins.

Hydrophilic media and depth filters. Cellulosic, Diatomaceous earth + cellulose, GF, polyproylene and nano fiber disposable capsules or cartridges. For clarification, prefiltration or to protect columns. Many different inlet / outlet connections, with or without vents and drains. SIP / Autoclavable. Specify when gamma stability is required.

Our integrated single-use bioreactors are designed as complete out-of-the-box jacketed systems, each paired with an integrated controller and temperature control unit (TCU).

Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.

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