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The Role of Orthogonal Technologies in the Detection of Protein Aggregation During Biopharmaceutical Development

Speaker:  Danny Chou, PhD, Founder & President, Compassion Biosolution

Duration:  60 Minutes

The presence of aggregates can greatly affect the quality and efficacy of protein drug products. Strategies for detecting, quantifying, and characterizing these aggregates and other subvisible particles are therefore critical in meeting the needs of regulatory bodies and customers, as well as successfully competing in the marketplace. While light obscuration (LO) is the compendial technique for detecting these aggregates, flow imaging microscopy (FIM) has recently gained prominence as an orthogonal technique for characterizing these particles.

In this webinar, Danny Chou discusses the opportunities and challenges in combining LO, FIM, and other orthogonal techniques for protein aggregate and particle characterization in biotherapeutic development and quality control. He also describes the benefits of combining orthogonal modalities on a single instrument and, in particular, demonstrates how combining FIM and LO on a single instrument can let labs:

  • Minimize required sample volume for particle analysis by analyzing the same sample with FIM and LO
  • Simultaneously test for USP compliance and confirm results with digital images to enable further investigation
  • Reconcile data between two techniques on the same sample

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