Summary
Biologic drugs have transformed modern medicine. Early biotherapeutics such as proteins and monoclonal antibodies took years to decades to develop, with analytical characterization being one of the most time-consuming steps.
Advancements in capillary electrophoresis (CE) technologies, when combined with downstream techniques such as high-resolution mass spectrometry and surface plasmon resonance have accelerated workflows, improved sensitivity, and enabled deeper characterization of complex molecules.
Emerging Modalities in Next-Generation Biotherapeutics and Biologics
In this era of next-generation biotherapeutics, novel and more effective biologics are growing in number, including antibody-drug conjugates (ADCs), bispecific antibodies, fusion proteins, and therapeutics utilizing viral vectors like LNPs and AAVs as delivery vehicles.
Key Analytical Challenges in Characterizing Next-Generation Therapeutics
The need for rapid, reliable analytical tools for protein charge and size characterization is greater than ever. These novel modalities introduce unique challenges to analyzing critical quality attributes (CQAs), including heterogeneity, stability, size and purity.
How CE-Based Systems Streamline Biotherapeutic Analysis and Ensure Quality
Discover how modern tools such as the Maurice™ and MauriceFlex™ Systems meet these challenges head-on by delivering:
CE-Based Assays: Features, Benefits, and Impact on Biotherapeutic Development
- Multiple CE-based assays—CE-SDS, icIEF, and icIEF fractionation—on a single system
- Fast, reproducible, and high-resolution data
- Accelerated development timelines
- Confidence in product quality from early research through commercial manufacturing
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