It is anticipated that cell and gene therapy (CGT) will be welcomed in cancer treatment as a ‘miracle technology.’ Due to its distinct characteristic, traditional therapies, cells and genetically engineered cells can attack the organs or tissue targeted for precise disease treatment like cancers.
Dr. Wenlin REN, Senior Product Development Manager of ACROBiosystems Inc. Image Credit: ACROBiosystems
Recently, the biopharmaceutical industry has been paying increased attention to “living drugs.” Moreover, the development of biotechnology has expedited CGT research, particularly in cell therapy.
For instance, chimeric antigen receptor T cells (CAR-T) therapy is now regarded as one of the most effective anti-cancer therapies, and it has already received approval in a number of countries around the world.
2073 active cell therapy drugs were in the global R&D pipeline in 2021; this represented an increase of 572 drugs compared to 2020, indicating a growth rate of 38%.
CGT-related drugs will continue to grow rapidly in the following years. It is also expected that alongside this explosive growth, cell therapy can advance therapies targeting immune-suppressing or 'cold' tumors, bringing about considerable progress in solid tumor treatment.
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
Dr. Wenlin Ren is a Senior Product Development Manager responsible for the development of target proteins, antibodies, and other related products, as well as upgrading the construction and iterative advances of new and existing technology platforms at ACROBiosystems.
Ren graduated from the School of Life Science at Tsinghua University and has more than a decade of experience in recombinant expression and structural analysis of transmembrane proteins, macromolecular proteins and complexes, as well as therapeutic antibodies. His work has been published in 10 SCI-indexed journals (such as Nature) as the first or corresponding author.
What do you think are the key aspects of quality control when developing cell therapy drugs?
Currently, in the case of CAR-T, there is no unified technical 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, requiring quality controls throughout the entire process.
When you began developing cell therapy-related reagents, what were your main intentions?
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.
What considerations should be taken when using raw materials in 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 the quality and safety of products, it is important to source them from companies that are able to provide them at a standard that adheres to local and international regulations.
What is your projected vision for developing the product lines of cell therapy-related reagents?
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 offering comprehensive support starting from the early research and development phase to production quality control and finally to clinical applications of cell therapy drugs.
The commercialization of a pharmaceutical project is one of the most difficult parts of the entire drug development process. ACRO plays a key role in this industrial chain, so I hope to assist in the standardization and development of the entire industry by being a member of ACROBiosystems.
About Dr. 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.
ACROBiosystems Group, founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and health industries by providing products and business models innovation. The company spans across the globe and maintains offices, R&D centers, and production bases in 12 different cities within the United States, Switzerland, England, Germany, and China. ACROBiosystems Group has established numerous long-term and stable partnerships with the world’s top pharmaceutical enterprises, including Pfizer, Novartis, and Johnson & Johnson, and numerous well-known academic institutes. The company comprises of several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.
ACROBiosystems’ brands include FLAG, Star Staining, ViruStop, Aneuro, ComboX, GENPower, and many others. Its main products and services are recombinant proteins, kits, antibodies, scientific services, and other related products. ACROBiosystems employs a strict quality control system for its products that are used in biopharmaceutical research and development, production, and clinical application. This includes targeted discovery and validation, candidate drug screening/optimization, CMC development and pilot production, preclinical research, clinical trials, commercial production, and clinical application of companion diagnostics.
Through the continuous development of new technologies and products, ACROBiosystems Group creates value for the global pharmaceutical industry and actively empowers our partners. The company is dedicated to accelerating the drug development process, including targeted therapies, immunotherapeutic drugs, and its clinical applications, and contributes to global health.
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