Jeff Clement talks with Manufacturing Chemist on the Large Scale Annex 1 Compliant Vial Filling and Lyophilization Expansion.
Can you provide an update on PCI’s $100 million investment to expand your sterile fill-finish capabilities?
As part of our global strategy to increase our sterile fill-finish capabilities and capacities, we have enhanced our Bedford, NH sterile fill-finish campus of excellence with a new 50,000 square foot multi-product facility. The expansion provides best-in-class late stage clinical and commercial-scale fully isolated vial filling and lyophilization solutions for new and existing clients.
The facility provides increased capacity using Annex 1 compliant technology, including an aseptic vial filling line within a fully isolated containment system, complete with twin 40m2 lyophilizers with automatic loading and unloading systems. Processing batch sizes up to 300,000 vials at a rate of 400 vials per minute (vpm) provides large scale capacity for the filling of life changing small molecules and biologics.
Truly supporting full product lifecycle management from formulation and lyophilization cycle development through clinical to commercial sterile manufacturing, this high-volume lyophilization and liquid filling facility provides our clinical stage clients a seamless solution for scale-up as they prepare for commercialization.
What benefits does this new technology present to your clients?
Having been systematically designed together by the manufacturers (groniger and SKAN) from the outset, this award winning line is one of the most versatile isolator lines in the industry.
The innovative technology not only streamlines the filling process, but also ensures the highest level of sterility assurance for the final product. The enclosed system provides a vital line of defence against contamination, safeguarding the integrity of drug products and ensures the safety of both patients and operators. The line employs the latest SKANFOG® decontamination technology which has been proven to effectively eliminate any potential micro-organisms. Using an advanced micro-nebulization process to optimize particle size of the VHP droplets, this technology uses 80% less VHP than traditional vaporization systems.
Designed to minimize product loss, and utilizing smart fill technology including peristaltic pumps, defective vial identification prior to filling, re-stoppering, and under-fill correction, ensures that there is no wastage of valuable product.
While minimizing any loss of Bulk Drug Substance, inline camera inspection systems check each vial for stopper placement and drug product. Our overarching philosophy at PCI, is to constantly strive for perfection, delivering a quality and sterility assured drug product to patients, while meeting regulatory standards including revised Annex 1 requirements.
When do you anticipate the site being operational?
Our expert technical, engineering and project management teams alongside our long-term contractor partners are working hard to have the site GMP production ready by first half of 2025. At the moment there is significant activity at the site with validation taking place. We are also hosting client visits, providing the opportunity to reserve capacity to secure their future sterile supply chains.
What efforts does PCI undertake to build robust supply chains and mitigate risk?
Biopharmaceutical companies demand secure and nimble supply chains, seeking service providers that can provide robust integrated solutions to support their drug products throughout their development lifecycle from early phase development and clinical studies to commercialization, mitigating the need to transfer between suppliers therefore reducing supply chain complexity and risk.
At PCI, ensuring the continuity of supply of life changing medicines is our highest priority. As a truly integrated and world leading global CDMO, we are manufacturing, packaging and supply chain experts, harnessing decades of experience and expertise to deliver seamless solutions with the ultimate aim of improving the lives of patients.
Providing scalable sterile drug product development, manufacturing and lyophilization solutions from development to commercialization together with integrated final assembly and packaging solutions for injectables, allows for ultimate knowledge sharing and communication between teams to ensure the drug product packaging is optimized for the product, patient and production. This integrated approach across global manufacturing and packaging teams not only streamlines supply chains but provides an accelerated delivery of life changing therapies to patients.
Large Scale Annex 1 Compliant Vial Filling and Lyophilization Expansion – As seen in Manufacturing Chemist with Jeff Clement
We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.
Find out more about our fully integrated CDMO Services.