Interview

03
Project Member (Analytical Researcher)
Shohei FUKUDA, Ph.D.

Our Aspiration to Contribute to the Pharmaceutical Industry at the Forefront of Trace Analysis

Analyzing at the ppb (Parts-Per-Billion) Level

My current work involves analyzing nitrosoamines in pharmaceuticals using a cutting-edge LC-MS/MS. We treat substances with extremely low concentrations at the parts-per-billion (ppb) level, which means we constantly face the risk of contamination during analysis. Even airborne dust or trace contaminants on our equipment can significantly affect experimental results. To prevent contamination, we take meticulous precautions, such as physical segregation of substances with large concentration differences, refinement of our work procedures, and changing gloves frequently. Moreover, whenever operational issues arise, we share the information as a team to prevent recurrence.

Cross-Generational Synergy, Achieved Through Open Communication

One of our most significant achievements is the “Towa Amine Approach.” This novel concept, originating from Director Uchikawa's extensive research expertise, involved a novel approach to focus on amine impurities, known as one of the precursors to form nitrosoamine. During analytical method development, my supervisor gave me a suggestion to try to connect two columns with different properties. As I worked to implement that idea, I faced challenges to proceed, but finally proposed an unprecedented approach to overcome existing challenges by using three different mobile phases, which was incorporated into our final method. The synergy achieved through open communication enabled us to establish a novel analytical method capable of simultaneously analyzing ten different types of amines.

Towa's Unique Value Proposition: Going Beyond Analysis

Believing we could contribute to the entire pharmaceutical industry by sharing this groundbreaking method, we decided to submit a paper regarding “Towa Amine Approach”. The peer-review process was challenging, and I almost lost heart because of the reviewer's harsh feedback. However, with the support of my well-experienced supervisor, we thoroughly demonstrated the method's scientific validity, and our paper was ultimately accepted. We can not only produce data, but also critically analyze the results and propose solutions to key challenges. I believe this is what differentiates us from the other analytical service providers and constitutes the unique value that Towa Pharmaceutical can offer.

Continuing to Take on Greater Challenges as an Analyst

If you were to ask how satisfied I am with my current job, I would say 20%. I don't mean this pessimistically; rather, I believe that satisfaction breeds complacency and halts growth. Thinking about the remaining 80% of potential motivates me to push further. I am convinced that trace analysis technology will become increasingly crucial in the future. I hope to contribute to the development of this field through technology transfer, for example, by implementing this technology at our sites in Japan and overseas and providing hands-on, on-site training.

(Interviewed in June 2025)

Interview

Aiming to Resolve Risks Associated with Pharmaceutical Components (Active Pharmaceutical Ingredients, Excipients)
Project Leader (Chemist)
Osamu UCHIKAWA, Ph.D.
Our Vision for “the NOx Think Tank”: Transcending Conventions to Forge the Future
Project Member (Engineer)
Hirokazu KISAKA
Pioneering the Development of a World's First Filter from Scratch
Project Member (Chemist)
Ryota NOMURA
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