DOWNSTREAM PROCESSING FEATURED ARTICLES
Untapped Potential Of Protein A To Be Highlighted At BPI Conference
Pete Gagnon, group manager for downstream processing at the Bioprocessing Technology Institute in Singapore, discusses his upcoming presentation at the 2015 BioProcess International (BPI) Conference. Protein A: the Fine Print, is one of several scheduled during the pre-conference symposia track, Innovation in Process and Product Development Technologies for Biopharmaceutical Development.
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![SterileConnectors]( "High-Flow Sterile Connectors For Single-Use Applications")
High-Flow Sterile Connectors For Single-Use ApplicationsOver the past decade, two developments have increased demand for high fl ow-rate connectors: Size advances in single-use bioreactors up to 2000L and the implementation of single-use downstream.
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Single-Use Standardization: Is It Holding Back The Biopharma Industry?
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
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International Stem Cell Corporation Demonstrates Positive Animal Efficacy Results In Metabolic Liver Disease Program
International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company") a California-based biotechnology company, today announced the conclusions from its study demonstrating the efficacy and safety of the hepatocyte-like cells (HLC) derived from human parthenogenetic stem cells (hpSC) in a well-established animal model of a congenital liver disorder associated with bilirubin metabolism.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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).
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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.
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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.
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![XDR-50MO]( "Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System")
Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor SystemThis application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
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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.
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Global Biochemical Profiling For Bioprocess Optimization
It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.
DOWNSTREAM PROCESSING PRODUCTS
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.
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.
Sartopore 2 XLM filter cartridges are especially designed for validated sterilizing grade filtration and reliable Mycoplasma removal of cell culutre media.
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.
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.