Do it once, do it right at Fermion's R&D
In the third part of the series we look at how Fermion’s R&D and engineering expertise creates cost-efficient and optimized processes for contract manufacturing clients. Read Part 1 about creating proposals and Part 2 about project management.
When Fermion launches into a new API contract manufacturing project, chemists and engineers get to work on creating the best possible process for making the new pharmaceutical ingredient.
But what exactly goes into creating the optimal chemistry and engineering process for a new API? And what does Fermion’s catchphrase “Do it once, do it right” mean?
Fermion’s R&D Director Arne Grumann and R&D Chemist Antti Kataja help us understand the intricacies of producing APIs efficiently.
More for less with early optimization
When a new client project begins, the organic chemists at Fermion set out to create an optimal API process for the client’s needs through systematic experiments. Put simply, the goal is to get more for less, but with the right quality.
“We look at each reaction phase in the chemical process, and fine tune them, step by step, for greater yield and purity,” Kataja explains. ”The client’s process may only be designed for lab scale and isn’t optimal for production in a plant. We need to develop robust and cost-efficient processes from the very start so the chemistry produces the best results throughout scale-up.”
Finding the right chemistry takes both creativity and discipline.
“We may only have a few months to test and develop the optimal process for the client’s API. You need to be both an inventive and rigorously systematic problem-solver: that’s the challenge and joy of being a chemist,” Kataja says.
Chemists and engineers working together
Roughly halfway through the development, a process engineer takes over the project and starts testing the process with production type equipment – first in pilot scale and scaling up toward production.
“The latter part of development and scale-up require deep engineering skills and technical understanding of production equipment. Having a dedicated engineer leading this part of development helps us avoid surprises in scale-up,” Grumann explains.
While the chemists are still involved, consulting and tweaking the chemical process, the engineer now takes the lead in testing critical process phases to see that they are robust, safe and efficient with Fermion’s equipment and facilities.
Experience and systematic development
The strength of Fermion’s API development comes from several different aspects. The first is having skilled chemists and engineers, who know what they are doing.
“We have a good mix of people with decades of experience and fresh talents who bring in the newest know-how from science and engineering universities,” Grumann says. “Our staff is motivated and proud of their work; each contracting client also gets that dedication employed in their API development.”
The second advantage is having a systematic approach for optimizing the API process.
“With over 40 years in the business – making APIs for both generics and proprietary drugs – we’ve created a model for development, where each step takes us systematically closer to the optimal process,” Grumann explains. “We also employ statistical tools – or Design of Experiments software – to help us guide the development efficiently.”
Do it once, do it right
The phrase “Do it once, do it right” describes Fermion’s ambitious outlook on API process optimization.
“We’ve established a systematic approach and know how to tweak the process from the start all the way through to bringing the product to market,” Kataja explains. “And of course, we also do lifecycle management and optimization for existing products as well.”
“’Do it once, do it right’ means that we don’t take short cuts that will cause problems later. Each development phase, starting from the lab scale, is optimized with the end goal in sight: making sure that the final chemical process is safe, robust, cost-efficient and compliant,” Grumann explains.