[Technology and Achievements] Establishment of a robust manufacturing method utilizing QbD experiments.
By optimizing the manufacturing process, we will establish a robust manufacturing method that takes into account applications and inquiries!
The management of active pharmaceutical ingredient quality required by ICH Q11 necessitates a deep understanding of the manufacturing process through QbD experiments. In other words, (1) selecting critical quality attributes (CQAs) of the active pharmaceutical ingredient and conducting risk assessment (FMEA), (2) extracting process critical parameter profiles (PCPPs) and evaluating them through multidimensional experiments such as quality engineering and design of experiments (DoE), and (3) extracting critical process parameters (CPPs) to optimize the manufacturing method, thereby establishing a robust manufacturing process that anticipates regulatory submissions and inquiries. On our website, we provide not only plots of predicted and measured values but also contour profiles, which you can view through the related links below. *For more details, please refer to the PDF materials or feel free to contact us.
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Our company is a pharmaceutical CMC research and development contract company that spun out from the CMC research division of Takeda Pharmaceutical Company Limited in July 2017. We support excellent pharmaceutical development as experts in CMC research. Our research team consists of experts with extensive experience and achievements in process chemistry, formulation research and development, and analytical testing development related to CMC research. We provide high-level services and solutions tailored to our customers' needs across each process from the early stages of pharmaceutical development to application, while flexibly collaborating. We have established a collaborative system with partner companies, enabling us to offer a one-stop service. Please utilize us as a platform for your pharmaceutical development.