Kenneth Glad
Highly regulated production work is becoming more complex across global facilities. The company is testing how far automation can go while keeping expert review in place.
AI is moving from pilot use into routine manufacturing support at FUJIFILM Biotechnologies, where global capacity is expanding and site transfers must stay tightly controlled.
According to Drug Discovery Trends, chief operating officer Maja Herold Pedersen is helping apply internal tools to deviation handling, technology transfer and regulated documentation.
For pharmaceutical and biotechnology companies that rely on contract manufacturers, the goal is practical: Cleaner records, faster technology transfers and less time spent organizing data as biologics move toward commercial production.
Pedersen said the company created GenkiBot, a protected internal AI system, so employees would have a secure alternative to public tools. It operates inside FUJIFILM’s own security framework.
She told Drug Discovery Trends that one early use supports deviation management by drafting records, coaching subject matter experts and reviewing root-cause patterns.
Her argument is not that AI should replace expert review. The technology can help prepare work until a trained expert needs to assess it.
Transfer speed is becoming a priority
In contract manufacturing, site transfers require technical data, batch knowledge and quality documentation to line up before production can begin. A weak handoff can delay a program even when capacity is available.
That is where FUJIFILM’s kojoX model matters. Drug Discovery Trends describes it as a standardized network approach covering equipment, processes and quality systems, designed to make biologics manufacturing processes easier to move between sites.
The company is expanding through a multibillion-dollar capacity push across the U.S. and Europe, including Holly Springs in North Carolina, Hillerød in Denmark and Teesside in the UK.
Maja Herold Pedersen became chief operating officer in September 2025 after previously serving as chief technology officer and chief quality officer.
“Lars Petersen, our CEO, knew me from before and knows how I lead. He knows that I push the boundaries,” she said. “I’ve never been a quality-function-only leader. I’ve always looked at the whole picture of how we get medicine to patients. It doesn’t matter whether I’m wearing a quality hat or some other hat, we need to make this work for patients in the end.”
The company’s “9 People Fundamentals” framework also supports the AI strategy, according to Drug Discovery Trends, by giving employees more decision-making room while making accountability part of the process.
Source: Drug Discovery Trends
