DOWNSTREAM PROCESSING FEATURED ARTICLES

GettyImages-1147006093 Cleanroom Clean White Facility The Real Threat To Biopharma Supply Chains: Bioprocessing Materials

The COVID-19 induced risk to biopharma is not a shortage of pharmaceutical ingredients. It’s the constricting supply of consumable materials and equipment necessary to produce therapies from them. Mike Piccarreta, Partner at Kearney, offers an outlook and practical advice on supply stabilization in this BioProcess Online exclusive. 

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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

  • Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes

    Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.

  • Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library

    Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.

  • Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion

    The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.

  • 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.

  • 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

DOWNSTREAM PROCESSING PRODUCTS

The electro-optical module EOM-O2-mini is a precise OEM solution for non-invasive oxygen sensor spots. Assembled according to ISO 9001:2000 they deliver certified quality.

A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.

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.
MicroRNAs (miRNAs) are small non-coding RNAs that regulate the activity of specific mRNA targets and play crucial roles in a wide variety of biological processes, including gene expression, development, proliferation, differentiation, and apoptosis.

Sartopore 2 XLM filter cartridges are especially designed for validated sterilizing grade filtration and reliable Mycoplasma removal of cell culutre media.

WHEATON’s selection of chromatography vials and accessories offers quality, value and reliability. WHEATON chromatography vials are designed for trouble-free operation in most autosamplers.

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.

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines.

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.

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