Drug product formulation & process development: the must-have skills at a glance

October 10, 2024

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Drug product formulation and process development are critical yet often understated aspects of developing new drugs. Professionals in this field possess multidisciplinary skills, including organic chemistry, analytical development, solid-state characterization, and knowledge of pharmaceutical excipients, manufacturing, and continuous improvement. Balancing these skills with the specific needs of each development phase is crucial.

Post-pandemic, biopharma investors have become more selective, prompting biotech companies to optimize drug development. An experienced team in drug formulation can enhance efficiency and mitigate risks throughout the drug life cycle. The article highlights key considerations across various stages of development, aimed at guiding small biopharma companies in selecting skilled drug product development professionals.

In the Inception Phase, professionals should possess broad scientific and multidisciplinary knowledge, including an understanding of disease pathways, pharmacology, drug delivery technologies, and raw materials. This expertise enables them to interact effectively with stakeholders and design suitable dosage forms.

During the Pre-Clinical and Clinical Phases, collaboration with drug substance, preclinical, and clinical teams is essential. Experts must understand drug substance characteristics, study designs, and timelines to develop appropriate formulations for each phase, considering factors like in vitro/in vivo models and dosage form compatibility.

In the Late Phases, the focus shifts to finalizing a robust, commercial-ready formulation that meets regulatory quality targets (QTPP). Collaboration with the process validation team ensures critical monitoring and control.

In summary, drug product formulation and process development require a blend of technical and multidisciplinary skills. Professionals must take a pragmatic approach to achieve the goals of the development program efficiently.

Michelle Gischewski, founder of KM Consulting-Pharma Intelligence LLC, is an experienced pharmacist with over 20 years of expertise in formulation and process development, having led teams at Eurofins CDMO, Apotex, and Teva. She helps clients navigate drug product development complexities through scientific and practical strategies.