The advanced therapies field is expected to grow at an impressive pace even with the recent global macroeconomic and COVID-19 pandemic setbacks. Despite the large pipeline of cell and gene therapy discovery research programs entering preclinical and clinical development, drug developers continue to encounter significant manufacturing and regulatory hurdles in moving from proof-of-concept research to conducting first-in-human clinical trials. The crux of these challenges is often tied to manufacturing unpreparedness associated with higher-quality raw and starting materials, controlled manufacturing processes, and qualified analytical assays for generating research materials and subsequent clinical products.
Drug developers can accelerate clinical development and shorten timelines by incorporating a scalable manufacturing process, utilizing robust analytics, and accounting for regulatory requirements and cleanroom compatibility at the discovery stage rather than at the Investigational New Drug (IND) application stage. By implementing these principles early on, drug developers can ensure consistent and high-quality data generation and gain better predictability of current good manufacturing (cGMP) practices, while also reducing the time and resources involved in conducting comparability studies in the transition from research to IND enablement.
In 2022, Thermo Fisher Scientific launched Patheon™ Translational Services to serve advanced therapy drug developers with lead identification and process establishment. Housed in a new, 32,000-square-foot facility in San Diego, Translational Services is dedicated to generating materials for molecular biology, viral vector manufacturing, and cell therapy services, as well as developing cGMP cell processing innovations for cell therapy research and development (R&D). Offering industry-leading, state-of-the-art instruments for production, analytics, and R&D, Translational Services supports clinically bound drug developers by providing access to an interdisciplinary team of scientists, bioprocessing engineers, and regulatory and quality assurance experts with over 30 years of cell and gene therapy experience.
Current capabilities include:
The Translational Services materials and processes are designed to seamlessly transfer into the cGMP environment.
The journey from designing advanced therapy manufacturing materials for clinical studies to bringing these therapies to patients is costly, time-sensitive, and filled with numerous risks. Partnering with an experienced service provider at the discovery phase can derisk and expedite the drug development process.
To learn more about Thermo Fisher’s advanced therapy CDMO services, solutions, and capabilities, please visit patheon.com/advancedtherapies.