Danny Chou, PhD discusses the opportunities, challenges and evolving regulatory expectations for orthogonal particle analysis for formulation development and quality control.

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, Ph.D. 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.

Key Topics Include:

  • What are the limitations of particle characterization with light obscuration alone? Why does the FDA require orthogonal techniques with imaging to aid in particle identification?
  • How can Flow Imaging Microscopy bridge the gap between LO and NTA and DLS?
  • What is the impact of combining FIM with LO to enable the detection of changes in particle distribution in the submicron to micron range?
  • How are regulatory expectations evolving for submicron particle characterization?
  • How does particle concentration differ in the submicron and micron range, and why does it matter for drug development?
  • How to implement orthogonal particle analysis technologies synergistically for both QC and product development purposes



Founder & President
Compassion BioSolution

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and Contract Development Service provider that serves clients throughout the world. Dr. Chou has over 20 years of experience in the pharmaceutical industry, both as a pharmacist and pharmaceutical scientist. Over the past 15 years he has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under a NIH Fellowship and his PharmD from the University of Florida.

Production Partner

Yokogawa Fluid Imaging Technologies

Yokogawa Fluid Imaging Technologies, Inc. manufactures industry-leading particle analysis instrumentation based on digital imaging technology. Our flagship product, the FlowCam, is the first automated particle analysis instrument to use digital imaging for measuring size and shape of microscopic particles in a fluid medium. With applications in oceanographic research, municipal water, biopharmaceutical formulations, chemicals, oil and gas, biofuels and many other markets, the FlowCam continues to lead the way in imaging particle analysis.

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