With so much time and resources invested upstream of sterile fill/finish manufacturing, any error at this late stage can be catastrophic. Potential impacts include production delays, product shortages, and, most importantly, risk to patients. At Selkirk Pharma, we mitigate these events in a variety of ways.
Our multidisciplinary project teams have over 17 years average experience in fill/finish manufacturing. As a result, they know what it takes to deliver your product on time and in full. This includes developing creative solutions to problems, implementing measures to avoid common pitfalls, and scaling up production as required. Importantly, all Selkirk employees are invested in being a flexible partner to ensure success with high-yield filling of your product.
When you hand your product over to us, you can be comfortable in the knowledge that it will be manufactured in a state-of-the-art facility. Unidirectional flow of personnel and materials serves to improve process efficiencies and prevent contamination, while best-in-class equipment and technology ensure consistently high yields.
From in-house analytical and microbiological testing to an ability to reach Pharma 4.0 with harmonized GMP compliance with US FDA and EU Annex 1 – the right fill/finish CMO makes all the difference in streamlining your project. We’ve designed reliability into our processes, ensuring tight control, avoiding outsourcing delays, and ensuring we’re up to date on the latest technologies. With a 27-acre campus, we also have ample room for expansion to grow with our clients as they scale and grow.
Our sterile fill/finish manufacturing services cover everything from compounding through to product release. At every step of the process, your product remains in the hands of a dedicated project team. An experienced Program Manager serves as a single point of contact to ensure your questions are answered promptly, but you’re welcome to interact with team members directly.