Helixmith Presents at Advanced Biopharmaceutical Regulatory Science Workshop

[Asia Economy Reporter Hyungsoo Park] Helixmith announced on the 4th that the presentation on production process development strategies at the ‘Advanced Biopharmaceutical Regulatory Science Workshop’ was featured in the journal Cell & Gene, which focuses on cell and gene therapies.

The Advanced Biopharmaceutical Regulatory Science Workshop was jointly hosted last October by the United States Pharmacopeia Convention (USP) and the National Institute of Food and Drug Safety Evaluation (NIFDS), a related agency of the Korean government. The event focused on quality evaluation and regulatory science of raw materials and finished products of advanced biopharmaceuticals, sharing the latest regulatory science information domestically and internationally, and discussing quality evaluation methods for advanced biopharmaceuticals.

Experts from academia, industry, and regulatory agencies both domestic and abroad gathered to discuss specialized topics related to process development, manufacturing process control, quality evaluation, and regulatory science of advanced biopharmaceuticals.

Helixmith’s Executive Director Kyungdong Bae, who is responsible for the CMC field including process development and production, delivered the presentation. He explained various factors to consider when scaling up advanced biopharmaceuticals from small laboratory scale to large-scale commercial production.

He also provided expert insights on the development stages of commercial production processes and analytical methods that can ensure reproducibility of biopharmaceutical quality. The presentation covered the importance of quality analysis and various approaches to achieve levels acceptable to regulatory agencies through comparative testing.

Through the workshop, Helixmith had the opportunity to share the technical foundation for the commercial success of Engensis (VM202), which is currently undergoing clinical trials in the United States. The company disseminated the technological capabilities secured during the development process of Engensis (VM202) to domestic and international experts.

This content was produced with the assistance of AI translation services.