Guillaume Ledoux has been working at Takeda in Neuchatel since September 2021 on a demanding but exciting project with important deadlines. Here’s more about the company, his previous experience, his mission, the atmosphere and the role agap2 plays.
Could you please introduce Takeda in a few words?
Takeda is a global pharmaceutical company. Here in Neuchatel, Takeda manufactures only two drug products through biotech processes. These drug products are two recombinant proteins, originating from the same process and separated during chromatography steps. The molecules are Factor VIII and Von Willebrand Factor, molecules that people suffering from haemophilia cannot produce naturally, leading to blood clotting issue. These drugs are considered lifesaving.
Is this your first mission for Takeda?
Yes and No. This is the first time I work for Takeda Neuchatel, but I have worked for Baxter in Belgium (Lessines site) which used to have common facilities with Takeda. However, the drug product manufacturing lines in Belgium and Switzerland are different and not related.
Could you please introduce the project you are currently working on?
Takeda Neuchatel is producing rAHF-PFM Bulk Drug Substance (BDS) and rVWF BDS via six bioreactors (separated in two different manufacturing lines with three bioreactors per line). The Biologics Network Guiding principles indicate that a global brand that is lifesaving and has significant revenue should be dual sourced to mitigate supply risks. The goal of the project is therefore to allow Takeda to address this issue and secure patient needs. To do so, it is necessary to add two more bioreactors to keep up with the global demand for its market-leading product and take over the production capacity of a manufacturing site abroad. The plan is to add one bioreactor in Neuchatel by 2023 and a second one by 2025.
In Neuchatel, each bioreactor has its own equipment trains (several tanks to feed media and buffer, as well as several harvest tanks, filtration skids, in depth filtration skids, etc.). The addition of one bioreactor on each lines means that all equipment trains have to be implemented, and some common tanks and equipment must be modified or improved to absorb yield and capacity increase. The project is based on a like for like capacity increase, while taking in charge all improvements needed and lessons learned from existing processes in order to meet commercial availability of materials from the newly installed bioreactors.
What is exciting about this project?
It is a very challenging project with demanding timelines, with major deadlines in 2023 and 2025. The project is a mix of a like to like philosophy for process but allows several changes concerning method and means of production. A lot of thinking outside the box is required. There is also a good knowledge of the process from colleagues, meaning that we can do a lot of improvement and deep dive into the process and operational description of the manufacturing line. Additionally, the standard of quality expected is very high, so I am learning constantly every day.
What makes you the right person to do this project? What qualities do you need for this project?
I have had several experiences in tech transfer and biotech process implementation (green fields) so I have a decent understanding of what lays ahead and how to deal with road block.
The necessary qualities are:
- Strong reactivity to adapt to last minute changes and all the interdependencies between the current process and the one we are implementing
- Clear communication as things are going fast and we deal with a lot of stakeholders
- Good technical knowledge as the project is very demanding.
How long have you been working on this project? How long will the mission last in total?
I started working here in September 2021, at the beginning of the project, and the mission will last until the end of 2025, after the second bioreactor and equipment train has been installed and validated. It will be my longest mission yet.
What is the working atmosphere like at Takeda? Is there a perceived difference between Takeda employees and agap2?
The atmosphere is very friendly although the big project is entering its hardest part and the communication is always frank and direct. The workload is high, but people are aware of it and mostly tolerant. I feel absolutely no difference between agap2 consultants and Takeda employees.
How does agap2 contribute to your daily life at work and the project you are working on?
Although I do not have a weekly contact with agap2, I know that I can call or get in touch with my business manager whenever I want. I feel strongly supported by agap2 and my manager, which feels very pleasant.