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— A talk with Dr. Wenlin REN
Cell and gene therapy (CGT) is expected to be a ‘miracle technology’ in cancer treatment. Due to its specific characteristic, conventional therapies, cells and genetically engineered cells can accurately attacks the targeted tissue or organs for disease treatment such as cancers. In recent years, “living drugs” are gaining more and more attention in the biopharmaceutical industry. Furthermore, development of the biotechnology has accelerated the research of CGT, especially in cell therapy. Chimeric antigen receptor T cells (CAR-T) therapy is currently regarded one of the most successful anti-cancer therapies that has been approved in many countries.
The global R&D pipeline in 2021 contained 2073 active cell therapy drugs, representing an increase of 572 drugs over the previous year with a growth rate of 38%. CGT-related drugs have grown and will grow rapidly in the following years. Alongside this explosive growth, cell therapy is also expected to advance therapies targeting 'cold' or immune-suppressing tumors, leading to significant breakthroughs in the treatment of solid tumors.
“The progress of antibody drug development in solid tumors is relatively slow, and CGT's research and development expects to make more breakthroughs in aspects that antibody drugs cannot reach.”
——Dr. Wenlin REN, Senior Product Development
Manager of ACROBiosystems Inc.
Currently, in the case of CAR-T, there is no unifiedtechnical standard for these cell therapy products. As both domestic and international authorities continue to formulate these standardization guidelines, each manufacturer has a significant amount of variance in CAR design, gene introduction methods, cell culture, and cell purification techniques. Thus, quality control of CAR-T cells should account for the specific production process and product characteristics. However, as a ‘living’ drug, CAR-T cells undergo a complex preparation process, therefore requiring quality controls throughout the entire process.
Cell therapy has advanced rapidly with an increasing number of candidates in the global R&D pipeline. However, reagents and other raw materials used in the development of cell therapy drugs on the market vary in quality which affects the drug development process. My intention at ACROBiosystems is to ensure that the products we supply to the global biopharmaceutical industry are of excellent quality and can consistently support the development of cell therapy drugs.
Raw (ancillary) materials used in the production of CAR-T cell therapy products refer to ALL biological and chemical raw materials used in the production process. This includes the target components of CAR-T cell products as well as culture media, PBMC isolation reagents, T-cell sorting reagents, activators, cytokines (e.g. IL-2, IL-7, and IL-15), serum or serum substitutes, etc. Since raw materials have an important impact on both quality and safety of products, it’s important to source them from companies that are able to provide them at a standard which adheres to local and international regulations.
Utilizing the strict GMP quality management system that ACROBiosystems has established, the current development of our cell therapy-related product lines will focus more on reagents used in the clinical stage to provide cell therapy drug development companies with high-quality, regulatory-compliant reagents and raw materials. In the future, we envision our team being capable of providing a one-stop solution to our customers and offer comprehensive support starting from the early research and development phase to production quality control, and finally to clinical applications of cell therapy drugs.
Dr. Wenlin REN
Senior Product Development Manager in charge of the development of target proteins, antibodies, and other related products, including the construction and iterative upgrades of new and existing technology platforms at ACROBiosystems.
● Graduated from the School of Life Science at Tsinghua University.
● Over 10 years’ experience in recombinant expression and structural analysis of transmembrane proteins, macromolecular proteins and complexes, as well as therapeutic antibodies.
● Published in 10 SCI-indexed journals (e.g, Nature) as the first or corresponding author.
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