Solutions > CMC Analytics and Optimization

CMC Analytics and Optimization

Drug yields are difficult to optimize given the wide range of parameters. Analytics such as colony counting and device production monitoring are time-consuming and labor-intensive. Optimizing CMC supply chains for API cost-of-goods and managing SOPs to align with differing international compliance standards add to the complexity. bPrescient can help, with systems, analytics, and data reporting to support efficient manufacturing, compliance, and reporting—from before IND filing through to commercialization.

Solution Overview Solution Benefits Relevant Expertise Example Tools and Data Sources

Solution Overview

Our solution for CMC Analytics and Optimization includes:

Development of digital twin and machine learning models to optimize processes, enhancing existing process analytical technologies.
Cloud-based analytics to provide on-demand compute resources for monitoring and optimization of key process steps.
Multi-parametric, non-linear methods to optimize yield, cost, time, and other critical factors in the CMC process.
LLMs and knowledge graphs to enhance development of SOPs that comply with local regulations worldwide.
AI methods for generation of regular compliance reports based on templates and past reporting.

Solution Benefits

Partnering with bPrescient benefits your R&D program in a variety of ways:

Improve operational efficiency and yield and reduce costs through guided process enhancements.
Improve accuracy in steps that are typically manual, such as colony counting and device monitoring, leading to reduced errors and cycle times.
CMC processes that optimize eventual API COGS to reduce overall manufacturing costs.
Reduce audit risk with accurate, efficient, and timely compliance reporting as well as with SOPs that comply with international standards and align with company’s global policies.