Accelerate market launch and optimize capital investment
Speed production, reduce variability and patient risk by leveraging process and quality data
Drug development is a costly, time-consuming process and can be made worse if Process Development, Manufacturing, and Quality Operation functions are disconnected. By not learning from past experiences, these areas can suffer from operational disruptions that drive up manufacturing costs. Ineffective management of regulatory actions and changing expectations leads to additional filings that cost the business time and money. And poor tech transfer from lab to in-house and outsourced operations can lead to brand risks.
Made to Cure for BioPharma is the only comprehensive, validatable-ready industry process to aggregate, contextualize and analyze quality and process data reducing time to market and manufacturing variability. By unifying process and quality data from disparate electronic and paper systems, organizations can quickly identify, understand, monitor and improve process and product variability. Data can be reused and shared across global operations internally and externally, thereby quickly spreading insights and knowledge to improve decision making.
Made to Cure for BioPharma integrates internal and external Process Development, Manufacturing, and Quality operational processes and supports right-first-time intiatives. It provides a foundation for creating commercially sustainable operations delivering business value from process and quality data and it minimizes risk and cost of quality and regulatory filings, updates and inspections while maximizing existing investments in process knowledge.
Key capabilities & benefits:
Create robust, sustainable commercial production environment by operationalizing critical process parameters
Monitor the performance of critical production process with data-driven decision-making
Identify and correct the causes of variability in a validated environment
Collaborate across global manufacturing and quality enterprise to improve efficiency by reusing process knowledge