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Q&A Article: Navigating Formulation Development - Key Considerations
Navigating Formulation Development: Key Questions for Pharmaceutical R&D Leaders
This article explores critical considerations in transforming drug candidates into optimized drug products, with a focus on formulation strategy for small molecule therapeutics. Addressing key questions, it highlights the importance of understanding API properties, defining a flexible Target Product Profile (TPP), using API classification systems like BCS and DCS, and leveraging bio-performance modeling. The piece also underscores practical factors such as manufacturability, technology selection, and scale-up in pharmaceutical R&D. Drawing from Serán’s expertise, it offers a comprehensive framework for guiding oral drug product design from early development through commercialization.
Source:
“Navigating Formulation Development: Key Questions for Pharmaceutical R&D Leaders.” Pharmaceutical Outsourcing, April/May/June 2025 issue, pp. 18–19.
About Serán
Serán BioScience, LLC, is a science-driven Drug Development Partner, recognized as a world leader in drug development. Utilizing a foundation of physical and chemical science, Serán designs robust formulations and engineered solutions to some of the industry's toughest drug product problems. Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product. Serán’s team has decades of experience developing complex drug molecules into enabling medicines. With every addition to our team, we further our commitment to our clients’ success. From preclinical to GMP and beyond, Serán is here to support you and your drug product every step of the way.
For more information, visit www.Seranbio.com or email us at hello@seranbio.com.
Contact
Serán BioScience, LLC
63047 Layton Ave, Bend, OR 97701 USA
www.seranbio.com
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