Optimizing Pharmaceutical Formulations: Strategies for Improving Stability and Minimizing Impurities

 

About the Webinar:

Join Amit Chivate, Ph.D., MBA, Senior Area Marketing Manager for Greater Asia and China at Roquette, and Cynthia Ciliberto, Ph.D., Director of Global Regulatory Affairs at Catalent, to learn more about nitrosamine mitigation strategies.

Nitrosamine impurities continue to present significant challenges to pharmaceutical safety and regulatory compliance, with direct implications for patient health. In this webinar, we will explore a set of effective, science-driven strategies to mitigate nitrosamine risks throughout the product lifecycle.

What you’ll learn:

• A three-pronged mitigation strategy to reduce nitrosamine risk
• How Roquette’s low-nitrite excipient portfolio supports safer formulations
• The role of excipients in nitrosative potential and nitrosatable amines
• Navigating regulatory expectations—including health authority queries
• Integrating risk reduction into early-phase clinical development

Ensure your products meet global safety standards while protecting patients—starting at the excipient level.

Date & Time & Timezone: Jun 4, 2025 03:00 PM in Amsterdam, Berlin, Rome, Stockholm, Vienna

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Highlights

Webinar: Optimizing Pharmaceutical Formulations: Strategies for Improving Stability and Minimizing Impurities

Business Sector: Pharma

Location: Online

Dates: June 4, 2025 – 3 p.m. CEST/9 a.m. EDT/18:30 p.m. IST

Speaker: Cynthia Ciliberto & Amit Chivate 

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Amit Chivate will present

Nitrosamine impurities continue to present significant challenges to pharmaceutical safety and regulatory compliance, with direct implications for patient health. In this webinar, we will explore a set of effective, science-driven strategies to mitigate nitrosamine risks throughout the product lifecycle.

Key focus areas include supporting pharmaceutical companies with an overview of Roquette’s manufacturing process—demonstrating how our raw materials, manufacturing practices, and packaging components are carefully controlled to avoid the presence of nitrosamine impurities or amine-contributing substances. In addition, we will discuss how Roquette’s excipient solutions support broader risk mitigation strategies by reducing the nitrosating potential of formulations through a low-nitrite excipient portfolio, and by minimizing exposure to conducive environments—such as process water and high-temperature conditions—that can facilitate nitrosamine formation. Together, these efforts form a three-pronged mitigation strategy aimed at eliminating or significantly reducing key contributors to nitrosamine risk.

This session will provide attendees with actionable insights into implementing these strategies effectively, reinforcing product integrity and regulatory compliance. At Roquette, ensuring patient safety through innovation and quality remains at the heart of our mission.

Cynthia Ciliberto will present

Focusing on the perspective for navigating nitrosamine risk assessment, performing confirmatory testing and responding to health authority information requests.

Pharmaceutical companies are expected to understand their drug product’s risk for forming nitrosamine impurities.  Over the last few years focus has shifted from identifying small molecule nitrosamines to nitrosamine drug substance impurities.  But do not forget that excipients can also pose a risk, not just for nitrosative potential but also for nitrosatable amines.  The regulatory expectation is not just for commercial products or those pending approval but also for products in clinical development.  From manufacturing active pharmaceutical ingredients and sourcing raw materials to understanding the impact of manufacturing and packaging operations, this presentation will dive into theoretical risks to examples of lab confirmed risks as well as mitigations performed.  This presentation will also provide information regarding various health authority questions, current regulatory expectations for control strategies and demonstrate the need to build mitigation into early phase clinical development formulations.

The webinar will conclude with a Q&A session.

 

For more information & registration here:

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Speakers:

Cynthia Ciliberto

Ph. D, Catalent

Cindy currently works at Catalent, a CDMO serving over 1000 clients in their goal of developing and manufacturing drugs and biologics for global markets. She is currently Director, Global Regulatory Affairs and the Leader of the Central Nitrosamine Team and previously the Director of Analytical Development for the St. Petersburg, Florida, site.

In her current role, Cindy trains employees and works with Catalent’s clients performing drug product nitrosamine assessments, facilitating nitrosamine testing, assisting clients with navigating regulatory inquiries and developing mitigation strategies for their drug products. Cindy has over 30 years’ experience in the pharmaceutical industry. Her background is in Analytical Development. She has been associated with large and small pharma working on NDAs, BLAs, ANDAs with respect to CMC development (analytical and formulation) as well as regulatory strategy for a wide range of dosage forms and delivery technologies.

She started her career in 1991 with Rhône Poulenc Rhorer (aka Aventis) and has worked at other notable companies such as Mylan Pharmaceuticals (Viatris) and Endo Pharmaceuticals. She also holds an MS in Regulatory Affairs/Quality Assurance and has been working for Temple University’s School of Pharmacy as an Adjunct Professor for the school’s Masters in RAQA program for the last 15 years. Her passion is learning/sharing knowledge, mentoring students for science fairs and developing reliable drug products to improve the lives of adult and pediatric patients.

 

Amit Chivate

Ph. D., MBA, Roquette Health & Pharma Solutions

Amit is a results-oriented pharmaceutical business professional with nearly two decades of experience spanning R&D, technical marketing, business development, and product management in both India and the US.

He has a Ph.D. in Pharmaceutical Drug Delivery and an MBA, providing a strong foundation to connect scientific innovation with strategic business thinking. Currently, the Senior Marketing Manager for the APAC region at Roquette, Amit leads the development and execution of targeted marketing strategies to support business growth and innovation.

With a career path from hands-on research and formulation development to strategic roles that bridge technical expertise with market insight, he has a strong grounding in excipient functionality and pharmaceutical formulation science, collaborating closely with R&D, regulatory, and quality teams to align product offerings with industry needs and compliance expectations. His core competencies include product development, innovation strategy, scientific communication, and pharmaceutical marketing—particularly in translating technical value into strategic market opportunities.

 

For more information & registration here:

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