Bioprocessing Application Notes & Case Studies

1. Maximizing Yield And Minimizing Risk In Aseptic Filling 10/15/2021

   Explore the process of how a new fill line was planned for and implemented, while also considering how best to mitigate contamination risks.

2. A ZipChip Based CZE-MS Analysis For Quick Assessment Of Biotherapeutics 10/13/2021

   Assessment of the heterogeneity of mAbs is essential for product quality control, especially for biosimliars. A quick study of a mAb for fast assessment can help save time and reduce bottlenecks with mass spectrometer usage for busy analytical laboratories.

3. Quantification Of Metabolites In Chemically Defined Media: An Example Of Method Accuracy And Reproducibility 10/8/2021

   When measuring analytes in complex cell culture media such as CHO and hybridoma media method accuracy and reproducibility are critical. The right analyzer can provide rapid and reliable quantitative cell culture media analysis.

4. Bioreactor Monitoring Via ZipChip CE-MS: Quantifying Amino Acids In Spent Growth Media 10/8/2021

   While many of the media components included to promote and sustain cell growth are small, polar analytes that can be difficult to analyze using conventional techniques we demonstrate a simple and rapid method for quantifying small molecules in spent growth media samples.

5. High-Throughput Intact Mass Analysis Of mAb-Based Therapeutics 10/8/2021

   Intact mass analysis of biotherapeutic proteins using mass spectrometry is a key characterization technique performed from upstream drug development to downstream product analysis. Review a method for high throughput analysis of monoclonal antibodies using a simple approach that can facilitate rapid MS characterization of biotherapeutic proteins.

6. Virus Reduction And Impurity Removal Potential Of Nuvia aPrime 4A Resin 10/6/2021

   In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development.

7. Preparing CHO Cells For Higher Productivity By Optimizing A Perfused Seed Train 10/6/2021

   Existing upstream equipment and/or facility infrastructure can present an impediment to intensification efforts and consequently limit gains in efficiency. This application note describes how N-1 perfusion using an expansion medium supports inoculation of a fed-batch, production bioreactor at a much higher cell density resulting in increased product titers.

8. Cell Line Development: Accelerating Antibody Discovery With The Octet® Platform 10/5/2021

   Cell line development involves multiple processes. Large numbers of clones are screened and selected on the basis of productivity and stability. An established platform for rapid titer of antibody clones can enable quick selection of high-producing clones.

9. Improve Scalability, Flexibility: Individualized Manifold Assemblies 9/27/2021

   How a CMO overcame an automated filling challenge when none of the single use manifold assemblies matched its requirements. 

10. Single Use Bags That Resist Vaporized Hydrogen Peroxide 9/21/2021

    Decontamination by vaporized hydrogen peroxide is common in the pharmaceutical industry. Here, we examine the resistance of RoSS and Bottle RoSS and components against 3% hydrogen peroxide.