What is the story about?
What's Happening?
A recent webinar hosted by Genetic Engineering and Biotechnology News (GEN) focused on high-throughput strategies to detect aggregates in biotherapeutics. Experts Karessa White, PhD, and Bud Halim, PhD, presented methods for identifying oligomers and high molecular weight species (HMWS) that pose challenges in biotherapeutic development. These aggregates can affect product efficacy, safety, and regulatory approval. The webinar highlighted the use of dynamic light scattering (DLS) and background membrane imaging (BMI) to characterize particles across various size regimes. The session aimed to provide practical strategies for monitoring aggregation from early formulation through development and manufacturing.
Why It's Important?
Detecting and managing aggregates in biotherapeutics is crucial for ensuring product safety and efficacy. Aggregates can compromise the stability of biologics, leading to potential safety issues and challenges in obtaining regulatory approval. The strategies discussed in the webinar offer valuable insights into maintaining the quality of biotherapeutics throughout their lifecycle. As the biopharmaceutical industry continues to grow, the ability to effectively monitor and control aggregation will be essential for meeting regulatory standards and ensuring patient safety. This focus on high-throughput detection methods reflects the industry's commitment to innovation and quality assurance.
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