Biosimilar App Notes & Case Studies
-
Benchmarking Filtration Performance Of TFF Cassettes
5/30/2025
Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.
-
Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
6/14/2024
Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.
-
Evaluation Of Extractables And Physical Compatibility Of The MobiusĀ® ADC Reactor Single-Use Components For ADC Manufacturing
10/29/2024
Explore study results evaluating the physical compatibility of single-use components in the Mobius® ADC Reactor and the level of extractables when exposed to dimethyl sulfoxide and dimethyl acetamide.
-
Technology Transfer Considerations
6/13/2024
Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.
-
Process Validation Considerations
6/13/2024
Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.
-
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.
-
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.
-
MobiusĀ® 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.
-
Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
11/21/2024
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
-
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.