Downstream Processing White Papers and Case Studies

31. Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance 4/24/2012

    Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

32. Accelerating Biopharmaceutical Development From DNA To Drug 7/8/2016

    In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.

33. White Paper: Capillary Electrophoresis — A Simple Technique

    In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.

34. Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion 3/26/2012

    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.

35. Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) 1/11/2012
    Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
36. 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.

37. Quality By Design In Biomanufacturing 12/22/2011

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

38. Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess

    The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.

39. Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities 4/18/2016

    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.

40. 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.