Downstream Processing White Papers and Case Studies

1. Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 6/10/2011
   Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
2. Global Biochemical Profiling For Bioprocess Optimization 6/12/2013

   It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.

3. Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks 8/16/2012

   Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time  for column loading.
    

4. CD69 Expression On Activated Lymphocytes Is Stable In Streck's Cyto-Chex® BCT 7/16/2012

   The purpose of this study was to determine if the activation marker, CD69, is preserved and stable in whole blood samples collected in Cyto-Chex® BCT. Previous studies have demonstrated CD marker stability of whole blood samples collected in Cyto-Chex BCT for up to 7 days when stored at room temperature (18-22°C).  By Jodi Alt, Ph.D

5. SciLog - Creating Advanced Biotech Equipment With Mettler Toledo 3/26/2012
   For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
6. 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.

7. 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.

8. 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

9. Examining Column Reproducibility During Method Development In Clinical Labs 6/28/2022

   In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

10. Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers 6/18/2013

    Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.