The Emerging Role of Excipients for Complex Biologic Therapies: Insights from Croda’s Leadership

In the following article, Croda International shares an exclusive conversation with one of its biologics leaders, Mo Pinto. From his early fascination with chemistry experiments to leading cutting-edge innovation in the Pharma division, Mo reflects on the experiences that shaped his scientific journey. He also offers valuable insights into the evolving challenges of excipient development for emerging modalities such as antibodies and gene therapies, the importance of oxidative stability, and the collaborative efforts required to bring new solutions to market.

Could you share a bit about your journey into science, particularly what ignited your passion?

As a child, I dreamed of working in agriculture and was inspired by the simple joy of gardening and horticulture. In my early adolescence, my interests shifted to chemistry. I enjoyed working with etching electronic circuit boards with reactive etching chemicals, experimenting with galvanoplasty, and replicating cool classical chemistry demos.

In high school, chemistry quickly became my favorite subject and fueled my curiosity so much that I used to read college-level textbooks on my own. During my senior year, my dedication was recognized when my chemistry teacher paid me to help him grade exams, essays, and projects for younger students.

I later went on to earn a B.S. in Chemistry with an Engineering minor. A pivotal internship developing resins for building materials at a petrochemical company sparked my lifelong interest in polymers and led me to pursue a Ph.D. in Polymer Science.

Over the past 20 years, I have contributed to many cutting-edge R&D projects and collaborated with a great number of multidisciplinary teams. This foundation ultimately prepared me for my current role in Croda’s Pharma division, where I am proud to fulfil a team leadership position.

Looking at emerging modalities, like antibodies and gene therapies, what unique challenges do these new areas pose for excipient development?

Antibodies and gene therapies introduce a new level of complexity, which traditional excipients are not always designed to handle. The biggest challenge lies in building meaningful structure-property-performance relationships by understanding the mechanisms of action and interpreting limited data. These therapies demand excipients that are tailored for stability, compatibility, and efficacy. At Croda, our team is constantly working to bridge these gaps by generating relevant data, applying advanced characterization tools, and collaborating closely with customers. This approach allows us to support innovation while ensuring our excipients offer true functional value for these novel treatments.

Oxidative stability is a known issue in formulations with excipients like polysorbates. How do you address this?

Croda Pharma excels at mitigating these challenges through its expertise in producing high-purity excipients with exceptionally low peroxide levels. Our proprietary Super Refined purification process significantly reduces impurities, enhancing formulation stability and extending shelf life. Over the past decade, we have continually evolved our purification technologies to address emerging challenges. Additionally, we provide our customers with guidance on best practices for handling, storing, and transporting raw materials and finished products, ensuring minimal oxidative degradation and optimal product stability.

Beyond technical hurdles, what are the biggest collaborative challenges in launching new excipient-based solutions?

Bringing new excipient-based solutions to market requires effective collaboration across multiple stakeholders. One of the biggest challenges is synchronizing priorities and schedules among team members and partners. In the initial project stage, I wear multiple hats, coordinating tasks such as raw material procurement, supplier qualification, analytical method development, and developing new manufacturing procedures. To overcome these challenges, I believe it’s essential to establish clear communication channels, define common goals, and ensure that all stakeholders are aligned. In my experience, managing these collaborative efforts can be just as demanding as the technical aspects of the project, but it’s crucial for driving innovation and delivering results.

How do you stay current with advancements in excipient science and regulatory trends? Any tips for peers?

Read as much as possible! I regularly read scientific literature and patents, as well as monitor industry trends through marketing material, social media, and competitor activities. In addition, I explore emerging tools, like AI, which can be surprisingly helpful for generating new perspectives. And lastly, our very own customers can be the best source of information!

When you are not working, what helps you recharge and stay inspired?

To recharge my batteries and fuel my creativity, I prioritize self-care and activities that bring me joy. Outside of work, I make time for physical activity, healthy habits, and quality time with loved ones. These routines help me stay energized and focused. I also enjoy cooking, listening to music, and tackling challenges in my personal time. Taking time to disconnect allows the mind to reset and often leads to a fresh and more innovative thinking when I return to work.

Source: Croda Website, Biologic Leaders: Mo Pinto