Andrew Kenna is a Senior Scientist with the Pharmaceutics Group at Catalent’s San Diego Facility, which focuses on early phase development, bioavailability enhancement and Phase I/II clinical manufacturing. Andrew received his B.S. in Biochemistry from The University of Texas at Austin.
Andrew has worked in pharmaceutical contract research for over 13 years where he developed his expertise in solid oral dosage formulation including but not limited to formulation and process development, troubleshooting, and scale-up of multiple solid dosage forms and processes.
Since 2016 Andrew has been the spray dry dispersion formulation lead for the Optiform® Solution Suite, Catalent’s early phase formulation screening platform. Today, Andrew leads a small team of formulators on a variety of solid oral dosage form projects ranging from simple powder in capsule to spray dried dispersion based extended release products.
Learn more on how he helps to solve complex formulation challenges for scalability in some of his recent work.
Get to know this Catalyst in drug product development.
Key Expertise: Oral Formulation
Connect with Andrew Kenna on LinkedIn
A CONVERSATION WITH ANDREW KENNA
How do you determine feasibility of a molecule for the spray drying process Catalent?
When a client comes to us with a molecule that they believe needs bioavailability enhancement in order to be viable we like to begin with an assessment of the molecule not only for spray drying but for other technologies in the Catalent network. First, we rank the molecule’s permeability and solubility on the Developability Classification System (DSC) to understand whether Bioavailability Enhancement is needed at all for the dose required. We want to make sure that we are providing the best option for our clients, so we don’t complicate the development process. We also evaluate the molecule’s solubility and stability in several single and binary solvent systems to make sure we don’t need to spray a large amount of solvent in order to produce our SDD, which can get very costly at larger scales. We make sure that if we choose spray drying, we can produce a formulation that will be successful at a scale for our clients.
Can you elaborate on the polymer screening process of a molecule for the spray drying process at Catalent?
Catalent had made significant advancements in how we screen for polymer systems for spray drying. We use empirical methods for screening polymer systems by making small scale prototype formulations and evaluating them for amorphous content, physical/chemical stability, and supersaturation potential. We are starting to implement material sparing screening techniques for SDD utilizing a µDISS Profiler™, an in situ fiber optic UV monitoring system with real time data display from parallel measurement cells. It allows us to see at what concentration and for which polymer system the API is being sustained at that supersaturated state and for how long. This helps us screen a larger number of polymer systems with less API and eliminate systems which are not performing without having to make multiple spray dried dispersions on lab scale equipment.
What are some additional projects that you are currently working on at Catalent?
I am helping explore some other materials that can be produced via spray drying. For example, we are working with spray drying of proteins for long term storage purposes. Typically, this work is done by lyophilization but spray drying offers an alternative that can be a continuous process. That is not to say there are not challenges related to making sure the protein doesn’t denature during processing, but we have had success spraying stable protein formulations containing a stabilizing excipient.
What has been your greatest achievement at Catalent?
It’s very hard to choose, I feel like there have been so many great moments for me since joining Catalent 3 years ago. One of my greatest achievements here at Catalent has been to help build and improve our screening and feasibility methods for early spray dried development work especially for the Optiform® but also build and train my current team of younger scientists here at the site. To be able to take the knowledge I’ve learned over the past decade in the industry and pass that along to them has been incredibly satisfying. It’s great to see them take that knowledge and expand on it themselves to help solve complex formulation challenges for our clients. However, nothing feels better than to take on a challenging program and then get our clients a solution which ultimately will lead to helping patients.