Your Innovative API from Development to Market, Part 1: The Proposal
In the first part of our series we look at the early stage of a contracted API development and manufacturing project: choosing the right partner through an RFP process.
Let’s say a pharma company has created a promising, innovative active pharmaceutical ingredient. But they lack the right manufacturing facilities to produce the API in commercial quantities or need specialist know-how to develop the product, optimize the process and scale it up for clinical trial material production. What they then need is a contract development and manufacturing partner, a CDMO.
But how to find and choose the right one? Finnish API manufacturer Fermion’s Eeva Kronqvist, Business Development Manager, walks us through the typical interactions between a client and a CDMO when first establishing a collaboration relationship.
1) Meeting partners
Pharma clients and CDMOs often make first contact at international pharma conventions and events.
“Clients can find Fermion representatives for instance at CPhI, DCAT Week and ChemOutsourcing. We also set up one-on-one meetings with pharma companies at their offices,” Eeva says.
Since the business involves high-tech innovation, it’s good practice to set up a confidentiality agreement early on, even before a project is on the table.
“We gladly sign confidentiality agreements with customers at any point, so they can feel comfortable communicating with us,”Eeva explains.
2) Request for Proposals
Once the client has discovered a new molecule for which it needs a CDMO to advance the molecule to clinical development, it’s time to send out a request for proposal, an RFP. Some clients approach Fermion with more mature products and the RFP then aims at finding a site for the technical transfer of production.
The RFP details the product and services the company wishes to procure: the API, its manufacturing process and analytical methods, quality requirements, material demand projections and the schedule of the project.
“A well-designed RFP is the best way to ensure the CDMO and the client are on the same page about what the deliverables, goals, processes and timeline of a project are,” Eeva explains. “We encourage our clients to invest enough time into developing a detailed RFP.”
3) Evaluation and Proposal
On Fermion’s side, the RFP will first go through an internal, 24-hour pre-evaluation, which determines whether Fermion has the right technical fit and resources to produce the molecule in question. Fermion’s ability and know-how to produce high-potency APIs enables Fermion to support a large variety of customer needs.
Then, the project moves to an evaluation team which starts preparing the proposal.
“The evaluation team includes our research and development chemists, process engineers, the project manager and plant directors as well as quality control and quality assurance specialists,” Eeva says. “They go through all the technical documents and create a methodical proposal, often with process improvement suggestions.”
“As a contracting partner, Fermion is like an extension of the client’s R&D. We think in the client’s best interest and always strive to create the most cost-efficient process suitable for a particular stage of development. We even tailor unique lifecycle management and engineering solutions for more mature APIs in the spirit of continuous improvement and cost savings. We also make sure to offer realistic timelines: what we offer is what you get”, Eeva says.
4) Site visits
Clients usually also visit the manufacturing sites before making the final selection.
“We host dozens of evaluation visits and formal audits by our clients each year,” Eeva says.
“Clients usually visit our R&D and kilo labs as well as the analytical development and QC department, located in Espoo, in the capital region of Finland. Many also take the 1-hour flight to Oulu to see the pilot plant and commercial production or combine visiting the Espoo site with a tour of our largest commercial site in Hanko.”
If the client company is pleased with the proposal and facilities, it’s time to sign development and manufacturing contracts. The new, innovative API now has a CDMO to take it from early development to the next level and the mature product has found a new home. The project is ready for kick off!
Next up Part 2: Project Management and the Fermion experience