Regulatory bodies typically impose a limit on the acceptable degree of protein aggregation that a biotherapeutic may exhibit, and therefore the confirmation of protein aggregate levels is vital throughout the drug development and production process.
These resources describe rapid and reliable workflows for protein aggregation detection with solutions to improve productivity while giving you confidence in the ability to identify and separate higher order structures.
Aggregation screening requires a powerful and flexible UHPLC. To optimize your separation, the column selection is critical in this workflow. MAbPac SEC has a proprietary hydrophilic bonded layer that results in minimal non-desired interactions between the stationary phase and the biomolecules. Its nonmetallic and biocompatible PEEK housing eliminates metal contamination from the column.
|Application Note||SEC-MS with Volatile Buffers for Characterization of Biopharmaceuticals|
|Application Note||HIC as a Complementary, Confirmatory Tool to SEC for the Analysis of mAb Aggregates|
|Application Note||The importance of correct UHPLC instrument setup for protein aggregate analysis by size-exclusion chromatography|
|Application Note||A universal chromatography method for aggregate analysis of monoclonal antibodies|
|Application Note||High-throughput protein aggregate analysis of monoclonal antibodies using a novel dual-channel UHPLC instrument|
|Application Note||Doubling the throughput of long chromatographic methods by using a novel Dual LC workflow|
|Application Note||Simultaneous analysis of monoclonal antibodies using a novel dual-channel UHPLC instrument and orthogonal chromatography|
|Article||'Ultra' Biotherapeutic Characterization|
|Blog Article||Avoiding Deadly Aggregates in Bio-therapies: Part 1 of a Monoclonal Antibody Characterization Series|
|Poster Note||Lifetime stability of size exclusion chromatography columns for protein aggregate analysis|
|Protein Aggregate Methods||AppsLab Library - Aggregate Methods|
|Webinar series||Get Greater Structural Insight into Biotherapeutic Proteins: Charge Variants and Aggregates|