Capillary Electrophoresis Services
Capillary Electrophoresis (CE) is a highly efficient analytical technique used in drug development and manufacturing for the separation and analysis of compounds based on their size, charge, and hydrophobicity. Its applications range from the analysis of proteins, peptides, and nucleic acids to small molecule drugs and glycan profiling. By providing detailed insights into the purity, stability, and pharmacokinetics of drug products, CE plays a critical role in ensuring the safety, efficacy, and quality of pharmaceuticals.
Our Expertise
We have incorporated the SCIEX PA800 Plus Pharmaceutical Analysis System into our suite of analytical tools, bolstering our ability to support biotherapeutics and vaccine characterization for regulatory submissions. Leveraging our extensive experience, we assist clients in validating a variety of CE assays to characterize viral vectors, protein therapeutics, in vitro transcribed RNA, guide RNA, Cas9 mRNA, and more.
Selected Applications:
Application
Description
Glycan Analysis
The PA 800 Plus allows for detailed glycan profiling, essential for characterizing glycosylation patterns in therapeutic proteins. This analysis helps ensure the efficacy and safety of biologics by confirming that glycan structures meet required specifications.
Charge Heterogeneity
The PA 800 Plus system performs charge heterogeneity analysis to separate proteins based on their isoelectric points, crucial for evaluating protein stability and activity. This helps in identifying charge variants that can affect the therapeutic performance of biopharmaceuticals.
Cell Line Analysis
The PA 800 Plus is used to analyze cell lines to ensure the quality and consistency of biopharmaceutical production. It helps in monitoring protein expression levels and detecting residual host cell proteins, ensuring product purity and safety.
mRNA Analysis
The PA 800 plus system supports the analysis of mRNA used in therapeutics, including vaccines and gene therapies. It assesses the purity and integrity of mRNA, ensuring it meets quality standards for effective therapeutic application.
Plasmid DNA Analysis
The PA 800 Plus facilitates the characterization of plasmid DNA, which is crucial for gene therapy and vaccine development. It helps in assessing the purity, supercoiled and linear forms, and identity of plasmid DNA to meet regulatory requirements.
Cell and Gene Therapy
The PA 800 plus supports the development and quality control of cell and gene therapy products by analyzing viral vectors and cell products. For viral vectors, this system can be used to evaluate capsid protein purity and ratios, virus genome integrity, and empty-full capsid ratio. For gene editing applications, this system can be used for assessing the purity of guide RNA and purity and integrity of Cas9 mRNA.