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By utilizing our deep knowledge of chemistry, we rapidly develop and streamline your program development and your clinical and commercial timelines.
Our process development approach is defined and designed to ensure scale up directly from bench scale to final manufacturing.
Our Capabilities
Our development capabilities include:
Material generated is used to develop your early-stage material for analytical, formulation and lyophilization cycle development. Process Development works with Analytical Method Development (AMD) to determine your program quality attributes, design stability programs for process intermediates, and define your process hold steps. Our Process Development team determines the Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs). We design your processes to optimize yields and remove impurities with minimal steps and optimal recovery.
Using a diverse range of expertise in developing and manufacturing ADCs, bioconjugates and linker payloads, we create tailored solutions for your program.
We adapt our approach to shorten lead times and develop risk mitigation strategies to ensure your overall success in delivering vital medicines to patients safely.