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Kirk Reynolds, Ph.D.

SCIENTIST, INJECTABLE FORMULATION DEVELOPMENT

Kirk Reynolds is a Scientist, for Injectable Formulation Development, at Catalent’s San Diego, California Facility. He attended Westmont College and earned a B.S. in Chemistry and continued on to University of California, San Diego for his M.S. and achieved his Ph.D. at University of California, San Diego at the Scripps Institution of Oceanography. As a formulation scientist, Kirk specializes in early phase formulation development for parenteral products that are just coming out of discovery. He also works on the latest therapies in pre-clinical and early phase development across a broad range of injectable delivery routes. Currently he leads a team of talented formulators taking on the latest challenges in parenteral formulation development. As molecules coming out of discovery are trending towards poor aqueous solubility, his group actively explores novel methodologies and technologies to solve formulation challenges.

Discover what drives Kirk’s passion for injectable formulation development. Access his published works that include 4 peer reviewed articles.

Get to know this Catalyst in Drug Development.

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A CONVERSATION WITH KIRK REYNOLDS

Prior to Catalent, what type of Research did you do?

Prior to my time at Catalent, my research focused on using the latest sequencing data and bioinformatic technologies to express silent gene clusters. The goal of expressing these gene clusters was to produce novel natural products from Actinomyces bacteria and using those natural products as a source for new drug therapies. As part of this venture, I helped developed new recombinant technologies used to gain greater access to these silent gene clusters, which dramatically increased the rate of discovery of new small molecules. These small molecules were then evaluated as candidates for the treatment of bacterial and fungal infections as well as oncology applications. With about half of all FDA-approved small molecule treatments either directly from or inspired by molecules found in the terrestrial and marine environments, nature continues to provide a bounty of novel therapies.

What ways do you feel you (or your team) help drive Catalent’s Patient First mission?

Injectable formulation development offers a unique opportunity to consider a patient’s experience with a drug product. In addition to the fundamental formulation properties that provide a robust manufacturing process and product shelf life, formulation tolerability is a key pillar my team considers during development. Depending on the route of administration (intravenous, intramuscular, subcutaneous, intraocular, etc.), properties like pH, tonicity, viscosity, and buffer species all affect the patient experience. Many of our programs focus on oncology therapies, which often have highly compromised patient populations. My team is constantly asking the question, “Is there any way to make this treatment experience more comfortable for the patient?”. This mentality drives us to not only develop client-centric formulations but patient-centric formulations.

What drives your intrigue with early phase injectable formulation?

Injectable formulation is intriguing to me for many reasons but I’ve listed my top three here:

Injectable development focuses not only on small molecules, but also peptides and biologics. This diversity of active components means the types of problems we must solve remain diverse and challenging.

The delivery devices surrounding injectable dosing (prefilled syringes, auto-injection pens, skin mounted injectors, ect.) continue to evolve, pushing the delivery of injectable drugs farther away from the clinic and into the patient’s home. As a formulator, that forces us to innovate to make sure the product we’re developing can be administered, if needed, without the supervision of a healthcare provider.

Designing a formulation and a compounding process that is scalable beyond the bench and will transfer well to demo batches, manufacturing, and into fill-finish brings a level of long-term strategy to early phase work that I really enjoy.

Approximately how many molecules does your team work on in a given year?

Within the broader Catalent network, the San Diego site is positioned to be one of the first stops a molecule makes in its journey to become a commercial product. As a result, we see a large number of novel small molecules coming through our door representing dozens of indications. Often times, our clients are small start-ups or virtual companies and our partnership represents a significant responsibility in ensuring the program is set up for long term success from early phase to commercial. As a result of this unique position within the Catalent network, my team may work on over a dozen new molecules coming out of discovery each year that are making their way for the first time into development as a drug product.

What are your proudest achievements at Catalent?

I gain the greatest satisfaction from my work in solving challenging problems. One of the benefits of being an early phase site is our ability to learn and adapt quickly. Some of the best moments I’ve been a part of involve times where a client has come to us with a problem we’ve never encountered before, and my team has had to think critically, formulate a strategy, and execute a plan to solve the problem. This situation happens often at Catalent San Diego and results in expanding our technical knowledge and experience that we can then apply to future programs. In short, my proudest achievements involve many talented scientists coming together to achieve a common goal that benefits our own development, our client’s program, and the patients we serve.

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