John Bertagnolli Talks to Outsourcing Pharma About Manufacturing Biologics, Challenges with Expansion /Article/2024/04/12/Selkirk-s-rises-to-manufacturing-biologics-challenges-with-expansion

Selkirk Pharma says success hinges on ability to deliver on manufacturing promises

In the fast-paced domain of pharmaceutical contract development and manufacturing organizations (CDMOs), Selkirk Pharma believes it stands out as a beacon of innovation and reliability.

Founded in 2018 by a group of industry veterans with diverse expertise, the company has swiftly carved a niche for itself in the fill/finish segment of pharmaceutical manufacturing.

With a relentless focus on reliability and a commitment to excellence, the company says it is poised for a significant expansion that will not only bolster its operational capacity but also reinforce its capabilities.

In an exclusive interview during DCAT 2024, with John Bertagnolli, vice president of operations at this CDMO, OSP gained valuable insights into the company's expansion plans and technological advancements. Bertagnolli's leadership has been instrumental in shaping Selkirk Pharma's vision and driving its success in an increasingly competitive landscape.

“We pride ourselves on our unwavering commitment to reliability,” says Bertagnolli. “Our goal is to ensure that patients receive their medications on time, every time, without compromise.”

Central to the company's expansion strategy is its key focus on fill/finish operations. The company specializes in this critical step of the pharmaceutical manufacturing process, recognizing its pivotal role in delivering life-saving medications to patients. With meticulous planning and strategic foresight, Selkirk Pharma explained that it design edits facility to cater primarily to high-value, small volume batches, particularly in the realm of biologics.

“Our facility was purposefully designed to meet the needs of our clients, with a focus on reliability and quality," explains Bertagnolli. “From the outset, we knew that our success would hinge on our ability to deliver on our promises and exceed our clients' expectations.”

The initial phase of the expansion saw the launch of a state-of-the-art Bosch and Stroebel vial filling line, strategically positioned to address the unique challenges associated with manufacturing biologics. This cutting- edge facility was meticulously designed to ensure maximum product safety and minimize the risk of cross- contamination.

“Our unidirectional flow design is a testament to our unwavering commitment to product safety and quality,” states Bertagnolli. “By implementing this design, we can maintain cleanliness and uphold the highest standards of reliability.”

Furthermore, Selkirk Pharma has embraced digitization as a cornerstone of its operational strategy. By using cutting-edge technologies, the company says it aims to streamline operations, bolster data integrity, and elevate overall reliability.

“Our investment in digitization reflects our dedication to continuous improvement and innovation,” says Bertagnolli. “By leveraging advanced data acquisition systems and electronic batch records, we can ensure adherence to the most stringent quality standards and regulatory requirements.”

In addition to technological advancements, Selkirk Pharma places a strong emphasis on cultivating enduring partnerships with its clients. By prioritizing relationships founded on mutual trust and understanding, the company aims to tailor its services more precisely to meet the unique requirements of each client.

“Our goal is to foster long-term partnerships based on mutual respect and collaboration," emphasizes Bertagnolli. “By working closely with our clients, we can anticipate their needs and exceed their expectations at every turn.”

Looking ahead, Selkirk Pharma is poised to tackle the challenges inherent in growth, including the expansion of its workforce and facilities. With plans for eventual expansion into high-speed capacity and larger manufacturing systems, the company remains steadfast in its commitment to reliability and excellence.

“As we embark on this new phase of growth, our focus remains unchanged: to deliver life-saving medications to patients reliably and efficiently, ”concludes Bertagnolli. “With our unwavering dedication to reliability and quality, Selkirk Pharma is poised to lead the way in fill/finish operations, ensuring that patients receive the medications they need, when they need them, without compromise.”