Downstream Processing White Papers and Case Studies
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An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins
Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.
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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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Selecting The Optimal Resins For Endotoxin Depletion In Process Purification
8/3/2016
A guide to effectively remove endotoxins with versatile process resins.
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Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography
10/1/2016
The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.
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Agilent Microarray Grant Application Support White Paper
1/25/2012
This guide offers an overview of Agilent’s microarray and SureSelect product offerings with ordering details to assist researchers with the details of grant submission.
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Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media
10/3/2016
Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).
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The Next Bioprocessing Revolution: Functional Additives
11/1/2012
Now that many bioproduction technologies and processes are reaching maturity, manufacturers are seeking out the next level of refinements. As an extension of successful fed-batch strategies (such as the use of matched media and feeds), the next stage in bioprocess refinement involves the development of highly concentrated functional additives that can be added to each bioreactor run in the smallest amount necessary to give good titer increases.
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Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations
This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific
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Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing
7/30/2012
When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest
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Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins
8/3/2016
Native and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.