Biosimilar App Notes & Case Studies

  1. Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies 2/9/2024

    In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.

  2. Maximize Product Recovery In Bulk Filtration And Filling Flow Paths 12/15/2022

    Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize non-recoverable hold-up within the filtration and distribution flow path sections.

  3. Recombinant Protein Purification Optimization With HIC 5/1/2023

    A step-by-step high-throughput process development (HTPD) workflow to determine the optimal resin and initial conditions for hydrophobic interaction chromatography (HIC).

  4. Improve Speed To Market By Mitigating Vial And Stopper Incompatibility 10/1/2024

    Explore two studies that indicate for a properly-assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size or vial style.

  5. Optimizing The Formulation For A Monoclonal Antibody 8/21/2023

    An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

  6. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

    This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

  7. Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry 2/26/2024

    Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.

  8. Developing A HIC Polishing Step For The Removal Of mAb Aggregates 9/28/2023

    Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

  9. Production Of A Highly Concentrated Monoclonal Antibody 10/4/2024

    Discover how you can achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.

  10. Enabling Accelerated Raman Model Calibration For Real-Time Monitoring 6/14/2024

    This study evaluates an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.