License to Cure for BioPharma
Accelerate therapeutic development, approval, manufacturing, and supply, in a global landscape
Accelerate market launch and optimize capital investment
Drug development is a costly, time-consuming process. If not connected, Process Development, Manufacturing, and Quality Operation functions 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 industry solution experience is the only comprehensive industry solution using performance data from process development and production runs to aggregate, contextualize and analyze quality and process data in a validated environment 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, sharing insights and knowledge to improve decision making. Risk is minimized, streamlining the cost of quality and regulatory filings, updates and inspections while maximizing existing investments in process knowledge.
With increasing development costs and ever evolving global compliance needs, biopharmaceutical companies need more than incremental improvements for success.
Companies need to move beyond compliance requirements and transform their businesses by using a holistic approach that spans across the entire product lifecycle spectrum. Learn how digital transformation can harmonize an organization’s multiple sources of data to provide safe, efficacious products that reduces risk and the need for regulatory oversight.
Create a robust and sustainable commercial production process using data-driven understanding of critical process parameters
Monitor performance of critical production operations using process-specific analytics with automated alerts for improved decision making
Identify and correct causes of variability in a validated environment using performance data from process development and production runs
Collaborate across a global manufacturing and quality enterprise to improve efficiency by leveraging prior process knowledge
Today’s pharmaceutical industry, organizations must maximize efficiency and reduce costs in their production processes, while at the same time, monitor and maintain high product quality and yield, minimize variability, and meet regulatory requirements worldwide. Made to Cure for BioPharma provides capabilities that enable organizations to shorten process development times, reduce tech transfer costs, and bring quality products to market with lower risk and improved profitability.
Pacira Pharmacueticals faced a challenge common in evaluating the active pharaceutical ingredient (API) for the biopharma industry: Many biological molecules or molecules with complex structures do not follow the linear degradation trends typically seen in pharmaceuticals. But with the help of Dassault Systèmes' BIOVIA solutions, they were able to leverage the guidelines developed for allowing non-linear modeling in stability studies and gain greater insight of their stability data.