As part of Daiichi Sankyo’s transformation into a global oncology company, the way the company manufactures its medicines also needed to be transformed.
The Complexity of Crafting ADCs for Cancer Treatment
In 2017, Daiichi Sankyo made a bold investment decision to optimize and enhance its manufacturing capabilities in order to support the development of its growing ADC pipeline. The goal, which was achieved, was to triple the company’s ADC manufacturing capacity by 2021.
“As we strived to achieve this important goal, our team did not lose sight of the reason why we were working towards this achieavement - patients,” says Dr. Yabuta. “Advancing the science behind our monoclonal antibody manufacturing is an essential part of bringing our ADCs to cancer patients around the world.”
Now, with one ADC on the market in more than 40 countries and five others in various stages of clinical development across numerous types of cancer, Daiichi Sankyo has successfully built a world-class biologics manufacturing capability.
ADCs, which are precision medicines designed to deliver treatment directly to cancer cells, consist of three components: a monoclonal antibody that binds to a specific target expressed on tumors, a cytotoxic payload, and a linker that joins the antibody and payload together. Unlike small molecule medicines, which are made through chemical syntheses, constructing an ADC requires special rigor to bring all three of these highly specialized components together in one safe and effective medicine.
The monoclonal antibody part of the ADC is derived from ‘living’ cells that at first are only produced in small quantities in the research lab. Once large-scale clinical trials are underway in anticipation for eventual commercial use, major scaling up is required to mass produce millions and millions of the cells needed to create the monoclonal antibody.
One of the most challenging issues in increasing the production of monoclonal antibodies is the ability to control the replication of the “living” cells as they rapidly reproduce, requiring sophisticated scientific skills and technology. In fact, it can take several months to complete one step in this process—cell culture to purification—and Daiichi Sankyo is working to tackle this challenge by reducing production time significantly.
Continuous improvement and streamlining the ADC manufacturing process will be a key to Daiichi Sankyo’s continued success.
“Daiichi Sankyo has unique technologies in the processes behind producing and culturing cells,” continues Dr. Yabuta. “We are continuing our research to find a way to dramatically increase the pace of development and production efficiency by applying various technologies in biologics manufacturing. If these technologies are widely used, I am sure they will greatly benefit patients and society as a whole.”
ADCs are not the only complex manufacturing Daiichi Sankyo looks to tackle. Daiichi Sankyo currently markets a CAR-T cell therapy and an oncolytic virus in Japan. The company is working towards solidifying its manufacturing expertise for these innovative medicines in addition to other future modalities, including bispecific antibody that target two different antigens on the surface of a cancer cell; mRNA containing lipid nanoparticles (LNPs), a new type of vaccine platform; and, recombinant adeno-associated virus (rAAV) for gene therapy.
Daiichi Sankyo's Multi-modality Strategy
Continuous investment in its people--the researchers and technicians--who not only maintain the quality of the medicines being produced but also are the driving force for the future of Daiichi Sankyo and of utmost importance. People are instrumental to achieving Daiichi Sankyo’s ambition to become one of the world’s leading companies in biologics manufacturing. “We intend to continue to create an organization whose members can say to each other, ‘We are proud to be involved in manufacturing this important medicine,’ or ‘We are proud of our company’s dedication to improving the standard of care for people around the world,’” says Dr. Yabuta.
Dr. Yabuta currently serves as an Executive Officer and Head of the Biologics Unit at Daiichi Sankyo. He joined Daiichi Sankyo in 2010 from the pharmaceutical division at Suntory Co., Ltd. bringing 25 years of experience developing manufacturing methods of recombinant proteins and peptides used in biopharmaceutical development along with building manufacturing facilities. During his time at Daiichi Sankyo, Dr. Yabuta has been instrumental in building Daiichi Sankyo’s biologic manufacturing capabilities.
Interpersonal Communication and Timing are Important
Dr. Yabuta values personal encounters and timing in his work, meaning he always gathers information by communicating directly with people, which then allows him to take the right action at the right time. Since communication is central to his leadership style, as head of the division, he always tries to communicate with everyone equally, from new employees to general managers, regardless of their job title or level of seniority.
Outside of work, Dr. Yabuta likes running. A lot! In fact, he goes jogging nearly every early morning no matter how busy he is or where he is on a business trip (and even if the weather conditions are less than ideal). Before COVID-19, every year he participated in local relay races with about 20 employees, with his presence livening up the events and helping everyone to enjoy them even more by feeling connected with each other through a shared passion for running.