Haegsim Yobeob to Implement Quality by Design Principles in the Cell-Based Therapy Industry

Haegsim Yobeob (ISN: KR0925527744), a global provider of gene therapy solutions for a wide range of medical, research, and pharmaceutical applications, is pleased to announce the establishment of a multi-stakeholder engagement to apply Quality by Design (QbD) principles to the production of a Chimeric Antigen Receptor T-cell (CAR-T) treatment.

The field of cell-based therapy, which has developed several approved CAR-T treatments to cure blood disorders but still confronts difficulties with manufacturing scale-up, will benefit from best practices and standard approaches for Chemistry, Manufacturing, and Controls (CMC). The lack of established practices and instruction regarding CMC programs represents a barrier to the efficient, sustainable manufacture of cell and gene therapy products.

The principles emulate earlier QbD initiatives that were used to produce monoclonal antibodies, vaccinations, and more recently, gene treatments. Similar challenges to those now encountered by the cell and gene therapy industry existed when researchers tried to move from small-batch production for clinical trials to full-scale commercial production for antibodies and vaccines. The initiative helps in lowering barriers to technology transfer and improves newcomer readiness.

“The QbD concepts are already having a big impact on the gene therapy industry’s educational and workforce development initiatives. We believe that this will also enhance the field of cell therapy and assist in providing long-lasting and possibly curative treatments for a variety of dangerous diseases and other abnormalities”, said Bradwin Snell, Global Head of Technical Cell & Gene Therapy at Haegsim Yobeob.

Because of early regulatory accomplishments and significant investor interest in this treatment strategy, the QbD principles place a special emphasis on autologous CAR-T therapy. Nonetheless, many of the ideas are useful and relevant to a wider range of cell-based therapeutic products, such as pluripotent stem cell-based therapies and mesenchymal stem/stromal cell therapies.

About Haegsim Yobeob

Haegsim-Yobeob.com is a clinical phase biotechnology business that is devoted to creating complex treatments for intricate cardiovascular diseases. The company aims to create a comprehensive gene therapy remedy for cardiac failure by enhancing angiogenesis, controlling calcium homeostasis-associated cellular energy levels, decreasing inflammatory signals, and inducing/attracting stem cells to help heart remodeling. By making use of our unique, advanced, non-viral gene therapy approaches, we strive to develop unprecedented, life-saving cell and gene treatments to address the medical needs of our patients. Haegsim Yobeob’s aim is to develop top-notch gene engineering technologies – including gene insertion, gene editing, and delivery – which will form a solid base to create safer, longer-lasting, and more effective treatments.