Project Management and the Fermion experience
In the second part of the series we look at how Fermion makes sure API development projects are managed successfully. Read Part 1 about the Request for Proposal phase.
So your API has a CDMO taking care of development and manufacturing. But how to ensure the project moves along according to schedule and is on budget?
Fermion’s Senior Project Manager Kari Lappalainen (second from the right in the picture) shares his insights on best practices in project management.
Great Kick-off sets the Project on the right track
The first step in starting a new project is a kick-off meeting. All the key people from both the client’s and Fermion’s side get to know each other and create a shared understanding of the project’s goals, deliverables and practices.
“We agree on the roles and responsibilities of our team and the client’s representatives, go through the schedule and next steps of the project. It’s also important to agree on project tools and practices: such as how often we meet, and how the client wants to be updated on progress”, Lappalainen explains.
A secure cloud-based workspace is set up for managing documents. One of the most important things, according to Kari, is to set up direct lines of communication between the client and the CDMO’s Research & Development, Quality Control and Production specialists.
“Clear communication is absolutely key to a successful partnership. We’ve found that the best practice is to have experts talk directly to experts without project managers acting as a go-between,” Lappalainen says.
Project phases and how to tackle challenges
During the kick-off, the next steps of the project are agreed on. Generally, the project is divided into four major components, which each need a detailed schedule and resources:
1. Process Familiarization phase, where Fermion R&D staff tests each step of the manufacturing process of the API in laboratory scale up to 10 grams.
2. Process Optimization and Scale-Up where the process is fine-tuned and scaled up so larger quantities of the API can be manufactured using planned equipment and facilities in the plant.
3. Analytics, where Fermion’s Quality Control experts test and develop the analytical methods to ensure that the quality of the API is exactly according to the client’s specifications and targets.
4. Production, where the needed amount of API is manufactured under GMP.
During each phase, it’s important to keep the client updated regularly on the progress as well as possible speedbumps.
“Especially if there are any problems, we report immediately, and also proactively offer solutions to make sure that challenges are tackled as fast as possible,” Lappalainen says.
Principles for success: Transparency, Agility and Customer Experience
According to Kari, Fermion’s strengths in API development and manufacturing have been honed through decades of experience.
“We’ve been in this business since the 1970s, and know what successful API development projects require,” Lappalainen says. “Our experts are highly skilled at optimizing processes so that they are robust, quality compliant and cost-efficient from the laboratory phase up to commercial production.”
Besides the right know-how and resources, working with a client is all about transparent communication and proactive problem-solving with agile responses.
“We offer flexibility and the smoothest possible customer experience, so the clients want to work with us again.”