Ahead of CPHI North America, we caught up with Lisa Stiles, director, business development at Selkirk Pharma, an exhibitor at the event, to find out how the CMO is navigating regulatory changes, challenges and more.
Our new APS-qualified manufacturing facility aligns with Annex 1 compliance standards, which are critical for clients targeting European markets, while also meeting the highest quality standards for U.S. markets. Unlike older facilities undergoing retrofitting to meet these standards, our facility incorporates new technology designed from the ground up. We see investment in Annex 1 compliant technology and systems as a requirement for future production and a focus of pharmaceutical companies. Additionally, implementation of software-controlled systems for unidirectional control prevents flow errors for personnel and materials and is a critical step in compliance within a multi-product manufacturing facility.
The global regulatory environment, especially Annex 1, heavily influences the standards for parenteral drug manufacturers. Selkirk has proactively develop edits facilities to surpass these standards and leverages emerging technologies to stay ahead. Since its inception five years ago, Selkirk has prioritized cutting-edge technologies like isolator technology, software-controlled unidirectional airflow, and Pharma 4.0 investments. Implementing these technologies in new facilities poses substantial challenges and retrofitting them can be even more daunting. Unlike most CMOs that rely on procedural controls, Selkirk has engineered a software system to eliminate flow errors, addressing a complex issue without current market solutions and setting a forward-looking standard in anticipation of future advancements.
As a CMO, our top priority is the prompt, reliable delivery of high-quality and safe products to the pharmaceutical market. We constructed a specialized facility designed to support Pharma 4.0 initiatives, which emphasize the integration of digital technologies across Quality, Manufacturing, Supply Chain, Engineering, and Validation. This strategy aims to eliminate paper-based systems and streamline processes. Our comprehensive Digital Transformation Plan facilitates immediate access to real-time data, enhancing efficiency in clean and non- clean room operations, speeding up document reviews, resolving deviations quicker, and increasing manufacturing transparency for clients. Pharma 4.0 allows for exception-based reviews and real-time QC/QA, reducing factory disruptions and ensuring more consistent product delivery.
In addition, electronic documentation minimizes human errors by verifying data against set controls during entry and permitting progress only if these are met. Advanced analytics detect equipment and quality issues early, allowing real-time issue resolution by the Quality team, which shortens the overall review process and expedites the release of manufactured products. Implementing Pharma 4.0 significantly boosts quality and speeds up the delivery of our clients' injectable drugs to the market.
Plant1 was designed and built to house three filing lines. The current filling line manufactures vials and the two additional lines will increase both capabilities and available capacity, with the addition of syringe and cartridge filling. These new lines will be online in 2026. In addition, we have 19 acres of adjacent land slated for the construction of Plants 2 and 3, bringing needed capacity online as demand continues to grow for quality, reliable fill- finish manufacturing.
Pharma companies are looking for ways to reduce production bottlenecks, address product shortages and re-shore manufacturing. We will help them solve these challenges in a newly designed ,state-of-the-art facility. Customers can count on a team of industry veterans who average over 15 years of experience in pharmaceutical manufacturing and regulation. They will manage customer projects in a facility designed for unidirectional flow processing and GMP compliance with the FDA and EU Annex 1. Our goal as a team is to be the most reliable partner in our field. When we make a promise, everyone at Selkirk takes it personally.