Getting to know Justin Barrett, Director of Analytical Development

To create robust drug formulations and accelerate development from early-stage research through cGMP manufacturing, close collaboration between analytical teams and development partners is essential. At Serán Bioscience, this synergy is at the heart of our approach.

We spoke with Justin Barrett, Director of Analytical Services, to explore how Serán’s analytical team contributes to the development of better medicines. Justin shares insights into their collaborative workflow, the challenges and opportunities in analytical method development, and how his team supports reliable, data-driven decisions across the drug development pipeline.

In addition to his technical expertise, Justin also talks about his personal motivation—his commitment to making a meaningful impact on patients’ lives through science.

LISTEN NOW to discover how a thoughtful, integrated analytical strategy can streamline development and improve outcomes for both clients and their patients.

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What is your role at Serán?

I'm Director of Analytical Development. I came to Serán in 2022, moved here from Salt Lake City where I lived for 23 years and worked in industry during that entire time. My background is in analytical. I've worked for qc, I've worked for analytical R&D, doing method development, with HPLC and GCS and I've even worked with some startups in some medical device companies.

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How does Serán's analytical team support its client’s needs?

The analytical teams at Serán provide testing support to the formulation team so our scientists and engineers can make sound decisions. We optimize drug substance methods to ensure that they will work for our drug product formulations, and we provide IND enabling analytical work with appropriate oversight.

Serán's quality control team performs in process testing, releases clinical trial materials and performs ICH stability for up to five years and performs in house microbiology testing. We also provide method development qualification or validation of methods, late-stage analytical strategy and developing analytical methods in performing swab recovery studies for cleaning verifications.

The diverse teams bridge early development work and quality control with some members working on separate but parallel paths with the formulations team to guarantee our clients’ needs are taken care of.

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What is unique about Serán's approach to analytical?

Analytical is intimately incorporated into everything Serán does to support solid dosage forms as well as our clients regulatory and filing needs. Our right from the start approach to formulation development sets our clients up for success when they progress through their clinical stages. We aim to provide analytical methods from the very beginning that will sustain late-stage clinical trials, registration batches and commercial release. The structure of our analytical departments allows for alignment on things like data integrity, documentation and regulatory requirements. We are also able to share expertise and knowledge easily between groups, leading to faster resolution of issues and quicker problem solving. This minimizes complications that could add delays to our clients’ timelines.

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Serán has recently announced a major investment to enable a commercial facility in Bend. How does this impact your team’s work?

In order to go from supporting our clients with early phase clinical to supporting late phase registration and commercial and getting quality pharmaceuticals into patients’ hands, the analytical development team will be responsible for ensuring that the analytical methods are robust, fit for purpose, fully validated according to ICH guidelines and transferred into the quality control laboratory and appropriate for determining the safety, identity, strength, purity and quality of the medicines we manufacture for patients. We'll also assist our clients in a couple of other ways, like ensuring their dissolution method is discriminating as required by regulatory agencies and performing forced degradation studies on the final drug product.

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What do you like to do outside of work? What's your favorite thing about working for Serán?

I am an adoptive father. We adopted our little girl from Ethiopia, 14 years ago. She is now a sophomore in high school. Outside of work, I like to read. I'm a pretty avid reader, and I've just picked up fly fishing, so I'm excited about getting out on the river. And my favorite thing about working at Serán is the people. It's always about the people.

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Learn more about our science in our Knowledge Center and explore career opportunities at Serán.

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