Biosimilar App Notes & Case Studies

1. 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.

2. Mobius® ADC Reactor Performance 10/22/2024

   Learn about a family of single-use ADC reactors that has been developed to offer a safer and more efficient ADC production method than traditional mixing systems and meet the industry's growing needs.

3. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

   To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

4. Fab Fragment Development And Manufacturing For Clinical Trials 6/12/2024

   Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.

5. Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool 3/24/2025

   Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

6. 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.

7. 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.

8. Overcoming The Solubility Challenges Of Antibody-Drug Conjugates 6/3/2024

   Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

9. Scalability And Performance Of Single-Use Bioreactors 8/1/2023

   Here, we provide scalability data as a guide for process development and cross-scale performance expectations and characterize performance attributes of the impeller, spargers, Ultimus® film, and sensors.

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

    The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.