Downstream Processing White Papers and Case Studies

31. Biomanufacturing Debottlenecking And Process Optimization 3/6/2012

    Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G

32. Biomanufacturing Supply Chains 12/22/2011

    This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

33. Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action

    Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
    therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777.

34. 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.

35. 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.

36. Biomanufacturing Flexibility 12/22/2011

    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.

37. Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media

    CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.

38. A Purification Strategy For Clinical-Grade Monoclonal Antibody 10/3/2016

    mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture. 

39. 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.

40. 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.