In 2022 PCI Announced a $100 Million Investment into Expanding Its Sterile Fill-Finish Service Offering – Can You Provide an Update on How This is Progressing?   

To enhance our sterile fill-finish capabilities and capacities we committed $100M to expand our sterile development and manufacturing campus of excellence in Bedford, NH with a new multi-product, 50,000 square foot facility. Over the past two years, we have meticulously planned and methodically executed the expansion, allowing us to grow our breadth of services as a global CDMO, providing best-in-class late stage clinical and commercial scale fully isolated vial filling and lyophilization solutions for new and existing clients.   

The new facility will provide increased capacity featuring Annex 1 compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin lyophilizers (40 square meters / 430 square foot each) with automatic loading and unloading systems.  The filling line can process batch sizes up to 300,000 vials at a rate of 400 vials per minute (vpm) providing much needed large-scale capacity for the filling of life changing small molecules and biologics, including high-value APIs such as mABs, oligonucleotides, and peptide drug products. 

With over 25 years’ experience in lyophilization and sterile fill-finish manufacturing, PCI has developed industry leading technical expertise in the end-to-end processing of often challenging and complex processes. 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.  

How Does This New Technology Benefit Your Clients? 

Our new large-scale vial filling, designed by Groninger and SKAN is among the industry’s most versatile isolator lines. This innovative technology streamlines the filling process and ensures the highest level of sterility assurance for the final product. The enclosed system safeguards drug integrity and operator safety, employing the latest SKANFOG^® decontamination technology which has been proven to effectively eliminate any potential microorganisms. The SKANFOG system uses an advanced micro-nebulization process to optimize particle size of the VHP droplets, this technology uses 80% less VHP than traditional vaporization systems. 

To meet the growing product demand of some of the largest commercial requirements from our clients, this high-speed line can fill 400 vpm, fulfilling batch sizes up to 300,000 vials.  Additionally, the high-speed line’s smart fill technology minimizes product, ensuring no wastage of precious drug substance through features such as peristaltic pumps, defective vial identification prior to filling, re-stoppering, and under-fill correction.   

While minimizing any loss of API or 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 the recently revised Annex 1.   

When Will the New Site Be Operational, and What Additional Services will PCI offer?  

There installation of the lyophilization, filling and isolator equipment is underway with engineering and validation runs scheduled to take place in the autumn. The site will be ready for GMP production in the first quarter of 2025.  We are currently facilitating client visits to the site, and providing the opportunity to reserve capacity to help secure their future sterile supply chains. 

This site, is our third high throughput isolator based commercial sterile fill-finish facility that we have built across our global network in the last three years. Our expert technical, engineering and project management teams alongside our long-term contractor partners are experienced in delivering complex, time sensitive capital projects, and we have a high-level of confidence in meeting the 2025 operational timeline.