Alexey Bersenev is a pivotal figure in the field of cellular therapy, known for his work as a co-founder and Chief Technology Officer at Cell BioEngines. The company focuses on innovative "off-the-shelf" cell therapies that aim to revolutionize cancer treatment. His expertise spans clinical cell manufacturing, notably contributing to early CAR-T cell product development. Bersenev also plays significant roles at Yale University as Director of the Advanced Cell Therapy Lab. In the following sections, we explore various aspects of his career, achievements, and contributions to the biotech field.
Dr. Alexey Bersenev began his journey in Russia, earning his medical degree from the Izhevsk State Medical Institute. He later pursued a PhD in transplantation and pathology, which laid the groundwork for his career in cell biology and biotechnology. His postdoctoral work in Philadelphia honed his expertise in immunology and hematology, forming a solid academic foundation that has been instrumental in his professional endeavors.
Bersenev holds critical positions in the realm of cellular therapies. At Cell BioEngines, he oversees process development and manufacturing. He is also an Assistant Professor of Clinical Laboratory Medicine at Yale University, where he directs key laboratories dedicated to advanced cell therapy. His dual roles in academia and industry epitomize his commitment to bridging research and practical application to innovate in cancer treatment.
While at the University of Pennsylvania, Bersenev was integral in the manufacture of the first CAR-T cell products for clinical trials. This work was foundational in the development of modern CAR-T cell therapies, which have become a cornerstone of personalized cancer immunotherapy. His contributions include technology transfer to Novartis, a pivotal step in scaling these therapies for broader patient access.
Cell BioEngines, under Bersenev’s technical leadership, seeks to overcome the limitations of traditional cell therapies. The company’s use of healthy umbilical cord blood to produce consistent and scalable cell products represents a paradigm shift. Their proprietary Stem-SPACE platform enables the mass production of high-quality therapeutic cells at reduced costs, addressing significant bottlenecks in cell therapy manufacturing.
Bersenev has an extensive portfolio of scholarly work, with notable contributions to understanding stem cell biology and its applications. His research covers hematopoietic stem cell regulation and the development of gene-modified cell therapies, which are crucial for creating effective treatments with broad therapeutic potential.
One of Bersenev’s key insights pertains to the challenges in manufacturing cell therapies at scale. He has repeatedly highlighted the need for optimized, consistent processes that ensure product quality and safety, addressing variability that hinders clinical success. His work at GMP facilities has been central to advancing these manufacturing capabilities.
Dr. Bersenev’s work has influenced methodologies for stem cell expansion, particularly in leveraging microcarriers and bioreactors. These technologies are crucial for creating scalable cell therapies that maintain efficacy and safety across batches, a necessity for their commercialization and widespread clinical use.
Cell BioEngines focuses on clinical applications like hematopoietic stem cell transplantation, providing alternative treatments for patients lacking suitable bone marrow donors. Bersenev’s work ensures these therapies are accessible as "off-the-shelf" options, potentially benefiting a vast number of patients globally.
In 2023, an agreement with Miltenyi Bioindustry expanded Cell BioEngines’ capabilities in manufacturing stem cell therapies. Such collaborations enhance their research and development, allowing the company to accelerate clinical trials and improve therapeutic outcomes for conditions like blood cancers.
Looking to the future, Bersenev is poised to continue driving innovations in cell and gene therapy. His efforts in pre-clinical and clinical stages aim to expand treatment options for various cancers, leveraging technology to turn formidable diseases into manageable conditions. His vision for accessible, effective cell therapies continues to guide advancements in the field.
Alexey Bersenev’s work has significantly impacted the development and application of cell therapies, particularly in oncology. His contributions to CAR-T cell therapy and stem cell expansion have been transformative, driving advancements that promise to enhance patient outcomes. As he continues his work at Cell BioEngines and Yale University, his leadership in both scientific innovation and practical application will remain critical to advancing the field of biotechnology.