Before you sign a contract for fill/finish manufacturing, it helps to understand how the CMO will work with you to ensure success. Tech transfer – the detailed process of exchanging accumulated client knowledge about the drug to the CMO – is critical to on-time, in-full fill/finish.
Selkirk Pharma promises a robust, open project onboarding and tech transfer process. This includes meeting the Selkirk team that will be supporting you, collaborating on the development of the project plan, and executing to deliver on our promises.
Unlike other CMOs, Selkirk assembles a more fully diverse team of experts from across multiple disciplines, including project management, manufacturing, science and technology, quality, regulatory engineering supply chain, and more. Our expert Project Managers direct and lead the project from beginning to end.
We encourage our clients to attend an on-site or virtual kickoff meeting for rapid team building, which facilitates transparent, consistent, and accurate communications from the start.
Planning is the key to project success. Our kickoff includes the transfer of all information from the client to Selkirk including method transfer, technical studies, and documentation. With a solid understanding of the project, Selkirk then executes the plan to ensure our transfer activities deliver on expectations.
You’ll get a detailed project schedule to keep the transfer timeline on track. Regular meetings are scheduled to ensure accountability to that timeline, and that all tasks are completed as required by the plan.
Plans are only as good as the execution. Selkirk excels at turning ideas into success in GMP production. We identify and mitigate any potential gaps in the manufacturing process to ensure the consistent high quality and safety of your product.
From machinability runs to test our facility and equipment, to engineering batches to test the process, to running your GMP batch, Selkirk’s focus on expert execution of the plan delivers on our promise–on-time, in-full fill/finish manufacturing for you.
When you’re at the fill/finish stage – for clinical trials or commercial production – you want confidence in your CMO. Selkirk’s dedicated staff is as devoted to getting your drug to market as you are. We’ve organized our company and facilities to serve you.
From designated office space for clients to oversee our production, to manufacturing flexibility, to our robust processes and a culture of continuous improvement, Selkirk Pharma strives to be the CMO you want to work with – again and again.