Separation science includes analytical methods aimed at isolating, identifying and characterizing components within complex biological samples. It plays a critical role in detecting and quantifying purity, assessing molecular heterogeneity and characterizing structural variants, from early discovery to manufacturing and quality control for all therapeutic modalities.

As the therapeutic landscape evolves, our separations portfolio offers several advantages to handle increasingly diverse and complex modalities.

Capillary Electrophoresis: Precision in Charge and Size-Based Separation

CE provides valuable insights into quality attributes of biotherapeutics to address the evolving drug development pipeline.

The SCIEX BioPhase 8800 Capillary Electrophoresis system is a multi-capillary instrument designed for efficiency and minimal sample requirements. Perform gold standard assays like CE-SDS, CZE and cIEF to analyze the purity and heterogeneity of biotherapeutics and vaccines.

Key applications of CE:

• Monoclonal Antibodies – Charge variant analysis is used to detect heterogeneity to ensure efficacy and reduce immunogenicity
• Biologics – Enables detailed glycan profiling, critical for understanding post-translational modifications
• mRNA Therapies – Provides fragmentation analysis and assesses purity to confirm sequence integrity and ensure efficacy
• Antisense Oligonucleotides – Provides high-resolution separation of synthetic oligos to ensure sequence purity and structural accuracy
• Gene Editing – Separates related nucleic acid impurities and determines sizes and quantities for accurate analysis of gRNA characterization

Analytical Ultracentrifugation: Spin to Win with the Gold Standard

Analytical ultracentrifugation (AUC) is the most versatile, rigorous and accurate means for determining the molecular weight, hydrodynamic and thermodynamic properties of proteins or other macromolecules. Currently, no other technique is capable of providing the same range of information with a comparable level of precision and accuracy. The Beckman Coulter Life Sciences Optima AUC leverages absorbance modules to monitor biomolecules that have absorptive signatures and interference detection systems to monitor sedimentation differences between the sample and reference solutions.

There are three main methods employed with the Optima AUC.

• Sedimentation Velocity analyzes sample heterogeneity, size and shape, particle loading states, complex formation and dissociation kinetics
• Sedimentation Equilibrium determines molecular weights and oligomerization
• Density Gradient Equilibrium purifies and characterizes viral vectors and biologics

Advanced Liquid Chromatography (LC) Columns for Biotherapeutic Analysis

Phenomenex Biozen™ LC columns are designed to tackle the multifaceted needs of large molecule analysis. They leverage cutting-edge particle platforms individually designed and built to achieve high performance and robust protein characterization and quantitation. Each platform differs in the proprietary processing techniques used to control particle size and morphology.

Key Applications of LC Columns:

• Protein and Peptide Mapping: Confirmation of primary structures, post-translational modifications (PTMs), and impurities
• Glycan Analysis: Identification and quantification of various complex carbohydrate chains attached to proteins
• Oligonucleotide and mRNA Profiling: Confirmation and quantitation of nucleotide sequence, purity and modifications
• Other Critical Quality Attributes (CQAs): Novel columns designed to address the challenges of other protein and peptide CQAs such as Drug-to-Antibody Ratio (DAR) analysis, protein and peptide fragments and charge variant analysis

We see a way to improve the recovery and consistency of your biotherapeutic sample by more than 80%, significantly accelerating the drug development process.

Phenomenex | Biozen™ LC Columns

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As new therapies emerge, analytical needs will continue to evolve. Our technologies are designed to meet today’s challenges and scale with tomorrow’s pipelines. Contact an expert today to learn how we can partner with you to address your analytical needs.