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Ariana Low, Ph.D.

PRODUCT DEVELOPMENT PRINCIPAL FORMULATION SCIENTIST

Ariana Low is a Product Development Principal Formulation Scientist at Catalent’s Schorndorf Germany facility. She received a degree in Pharmacy and has also earned an industrial Ph.D. at the National University of Singapore in conjunction with AbbVie Inc.

Ariana specializes in formulation development of solid oral dosage forms. She helps bring molecules from Phase 1 to scale up and production by applying development tools employing Quality-by-Design principles from the ICH guidelines as part of the quality risk management system. Discover what drives her passion for formulation development, excipient optimization and quality assurance.

She also leads a team of 10 technicians for the daily running of the laboratory and overseeing technical trials and GMP production in the pilot-scale area.

Get to know this Catalyst in research development.

Connect with Ariana Low on LinkedIn

A CONVERSATION WITH ARIANA LOW, PH.D.

As a formulation scientist finding the right formulation is crucial for the intended application to work effectively. What are some ways you have been able to improve the patient experience utilizing excipient platforms?

An excipient platform, one such as the Optiform® Solution Suite that Catalent offers, allows the quick selection of formulations for the early stages of screening. Such platforms offer a fast turnaround time through more accurate and precise formulation development ensuring that medicines are brought to patients on time and in top quality.

The development of such an excipient platform involves the combination of prior knowledge from literature or internal experience with the several proof-of-concept experimental runs with placebo and model drug formulations. Physicochemical properties of formulation components as well as the manufacturing process are considered.

Each process is unique and involves a customized excipient platform. Formulations applying enabling technologies such as amorphous solid dispersions have overlap in the excipient platforms for processes such as spray drying, and hot-melt extrusion and formulation screening can be performed for both processes with one screening run.

In some cases, a formulation comes to your site in Phase III for process scale-up/ optimization and the customer prefers the formulation to remain the same. What tools have you applied to ensure scalability of such formulations?

It’s important to know and apply the guidelines for scale-up and post-approval changes to the dosage form and the manufacturing process. In some cases, small changes to the formulation, including up to 10% per excipient can be made, depending on the formulation type, i.e., immediate release, or sustained release.

If the customer prefers the formulation to remain the same, and if the evaluation of formulation components pose low risk to the scale-up process, we would suggest conducting a process optimization design of experiments (DoE) or comprehensive iterative experiments to evaluate the critical process parameters (CPP) for scale-up. CPP assessment would allow the establishment of a robust control strategy to facilitate an optimized manufacturing process.

Explain your approach to achieving high quality scientific results in Schorndorf.

I apply development tools that involve Quality-by-Design (QbD) principles from the ICH guidelines as part of the quality risk management system (QRMS) we have on site. This starts early in the product development process and lasts throughout the product life cycle for every product. We also have stringent stage-gate review meetings to ensure that there is enough data available for GMP production and ensure high quality products to patients.

I am spearheading the QRMS Core Team with my colleagues who are key players from quality assurance, product development and tech transfer. We all have our specific roles and are champions for QbD and Quality Risk Management in our own departments. The QRMS is a living system and evolves according to prior knowledge gained through experience and ongoing research.

What type of technologies do you and your team utilize to stay on top of industry trends?

Our product development team spent the last two years building a science-driven formulation design approach. Our new formulation design approach improves on the traditional method by applying relevant statistical models to connect material, processes and drug product critical quality attributes to enhance product understanding. This enables successful formulation predictions and manufacturing processes based on input material properties. We have successfully applied this method to multiple projects and have been able to deliver clinical supplies successfully or to troubleshoot ongoing projects in the manufacturing area.

For example, a formulation for stick pack filling needs to have good flowability to allow suitable content uniformity. We have an excipient database in Schorndorf with material attributes that can be compared with the incoming API or intermediate product that allows us to select excipients with suitable physicochemical properties.

What excites you the most about working at Catalent?

The most enjoyable part of my job is problem-solving with my team with the “Patient-First mindset. Being tasked with developing a new formulation or transferring and scaling up a sub-optimal process are examples of challenges that give me a great sense of satisfaction upon completion.

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