While seemingly simple, sterile fill/finish manufacturing represents a major bottleneck for the pharmaceutical industry that can lead to production delays. To increase the likelihood of receiving your product on time and in full, you need a CMO with state-of-the-art facilities and equipment, managed by experienced personnel.
Selkirk Pharma’s fill/finish services encompass compounding through product release, including all of the analytical testing and supply chain support required. Our purpose-built facility, in-house fill/finish services, and dedicated expert staff ensure that your project runs smoothly, achieves high yields, and is delivered on time.
Fill/Finish Services
Vial filling, stoppering, and sealing demands state-of-the-art equipment to avoid line loss and production delays. Our best-in-class systems for sterile fill/finish include a high yield Bausch + Ströbel VarioSys® fill line and SKAN isolator technology to ensure delivery of the product you want, at the high quality you need.
Because we perform 100% manual visual inspections, you can be confident that products processed at Selkirk are essentially particulate-free in accordance with USP guidelines and requirements. With the expertise to create our own Defect Kits in-house, we can provide time savings of up to 50% compared without sourcing to a third party/external service supplier.
Timely, high-accuracy analytical testing is essential for keeping projects on track. We perform an extensive selection of analytical and microbiological tests in-house to mitigate against outsourcing delays, using best-in-class equipment that has been qualified using 21 CFR part 11 standards for data integrity.
Once your product is ready for fill/finish manufacturing, the last thing you want is a lengthy wait for the right vials, stoppers, or excipients. At Selkirk, we work tirelessly with our suppliers to ensure that we’re ready to go from the outset. Take the stress out of fill/finish manufacturing by letting our reliable supply chain become a part of yours.
For smooth, successful regulatory submissions, Selkirk Pharma offers expertise and services in regulatory compliance, operations, and intelligence. From CMC and product lifecycle support in global markets to intelligence monitoring to stay abreast of regulatory changes, you have access to solid regulatory support to keep your product on track.
Don’t let late materials delay your clinical trials. Selkirk Pharma offers its proprietary process, ClinFAST™, to accelerate clinical trials materials – regardless of volume – for Phase 1, 2, and even 3 trials. If you’re being ignored, asked to wait, or told your volumes are too small, ClinFAST™ is the answer. Selkirk is committed to your success.