Biosimilar App Notes & Case Studies

1. An Innovative Approach To Streamline Raman Implementation 6/14/2024

   Standard methods for building Raman spectroscopy models are often time-consuming and resource-intensive. Explore one-batch calibration and how its performance compares to other modeling techniques.

2. Adapting Single-Use Chromatography To Manufacturing Scale 5/16/2024

   Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.

3. Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy 6/14/2024

   Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.

4. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

   Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

5. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

   Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

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

   Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.

7. Accelerate Process Development With Automated Aseptic Sampling 5/6/2024

   Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

8. Getting CMC Right For Emerging Technologies 12/20/2023

   Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

9. Cell Retention Technology And Specialized Cell Culture Media 8/11/2025

   Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.

10. 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.