DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• 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.

• 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.

• Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

  Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

• Sani-Tech® Ultra White Paper

  For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. 

• Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography

  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.

• Comparing The Automated Pipetting To Volumetric Glassware And Air Displacement Pipettes

  Analytical sample preparation is used in many industries such as forensics, environmental chemistry, mining, beer and wine fermentation and many others. Concentrated samples are diluted and analyzed via High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, and/or Inductively Coupled Plasma Spectroscopy to name a few. Traditionally these samples are prepared using volumetric glassware, syringes and/or pipettes.