The Global R&D Facility serves as the innovation engine behind OneSource’s development and manufacturing platform, supporting biologics, sterile injectables, drug-device combination products, and soft gelatin capsules.
Purpose-built to bridge the gap between early-stage development and commercial manufacturing, the facility brings together formulation science, process development, analytical expertise, and scale-up studies within a single integrated environment. By aligning development activities with manufacturing requirements from the outset, OneSource helps clients reduce technical risk, accelerate technology transfer, and prepare products for successful clinical and commercial execution.
The facility supports development programs across OneSource’s four core technology platforms, enabling multidisciplinary collaboration and shared technical expertise throughout the product lifecycle.
Successful commercialization begins with development strategies that anticipate manufacturing realities. At the Global R&D Facility, process development activities are designed to establish robust, scalable processes that can be transferred efficiently into clinical and commercial manufacturing environments. Development teams apply Quality by Design (QbD) principles, risk-based methodologies, and Design of Experiments (DoE) approaches to optimize processes and define critical quality and process parameters.
OneSource supports biologics development across microbial and mammalian expression systems through:
OneSource’s development capabilities for drug-device combination products include:
Softgel development capabilities include:
This work supports right-first-time transfer to OneSource’s commercial manufacturing facilities while reducing development timelines and improving operational efficiency.
A core function of the Global R&D Facility is helping clients transition from development to manufacturing with confidence.
Scale-up studies are designed to simulate commercial manufacturing conditions, enabling teams to identify scale-dependent risks, optimize process parameters, and establish robust transfer strategies before production begins.
Cell culture process scale-up strategies
Microbial fermentation process scale-up strategies
Injectable process scale-up and manufacturing simulation
Softgel encapsulation optimization
Process reproducibility and robustness assessments
This work supports right-first-time transfer to OneSource’s commercial manufacturing facilities while reducing development timelines and improving operational efficiency.
Analytical development is integrated throughout all development activities at the Global R&D Facility, supporting process understanding, product characterization, and regulatory readiness.
Together, these capabilities provide the data required to support informed development decisions, successful technology transfer, and regulatory filings.
Beyond routine analytics, the facility provides advanced characterization capabilities critical for biologics development.
OneSource’s development model is designed to integrate directly with its large-scale manufacturing operations.
Processes developed at our Global R&D facility are transferred into the Integrated Drug Substance and Drug Product manufacturing site using structured technology transfer methodologies, ensuring:
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