Downstream Processing White Papers and Case Studies

  1. Turning Data Into Information 12/22/2011

    As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

  2. Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

  3. Determination Of kLa Values Of Single-Use Bioreactors 8/3/2016

    Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

  4. 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.
  5. 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

  6. 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.

  7. Biomanufacturing Complexity 12/22/2011

    This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.

  8. 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.
  9. 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.

  10. 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.