The life sciences industry is the driving force behind major medical breakthroughs and therapies that ensure public health. The sustainability of a competitive, innovative biopharmaceutical sector depends on collaboration across enterprise to overcome bottlenecks and address key challenges.
Pharmaceutical companies typically are linked to a complex network of other organizations requiring partners adapt to meet changing regulatory compliance, as well as manage collaboration. In order to master the complex relationships that exist between process development, manufacturing, and quality operations as well as outsourced operations, companies must learn to flawlessly execute processes, leverage internal and external knowledge, conform to regulatory agencies and minimize risk while simultaneously facing pressure to reduce costs.
To meet these challenges, manufacturers need a business framework that integrates all areas of the extended enterprise so that every unit can leverage the same information. Additionally, real-time visibility into manufacturing and process data will provide the insight needed to understand critical process parameters so that manufacturers can quickly adapt operations for continuous improvement.
Dassault Systèmes’ Made to Cure for BioPharma provides a collaborative environment that helps speed time-to-market and maximize profitability. This solution enables pre-emptive action by providing visibility into process operations, quality and compliance risks, helping to optimize product quality as well as the production process of therapeutics.
Data Driven Insights for Business Improvement
Process development, manufacturing and quality functions generate an abundance of data, which needs to be presented in a user-friendly, organized form to be leveraged. Made to Cure for BioPharma provides all key stakeholders with self-service, on-demand access to process and quality data from disparate databases and paper records from one location helping users to gain process knowledge and improve production operations.
The access to timely and reliable analyses and reports helps support business as well as compliance requirements. The automatic aggregation and contextualization of the data delivers near real-time insight into operations enabling companies to 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.
Optimize Performance for Improved Profitability
Therapeutics manufacturing can be costly and ineffective management of regulatory actions can lead to additional filings costing both time and money. Poor tech transfer from lab to in-house and outsourced operations can result in inadequate therapeutics process design that failed to learn from prior experience. A collaborative validated business framework can help reduce operational disruptions that occur with disconnected systems and units that can lead to regulatory recalls that could potentially damage the brand in the marketplace.
By easily aggregating and contextualizing data and providing role-based visibility of critical production process and product parameters, Dassault Systèmes’ Made to Cure for BioPharma can shorten process development times, enable tech transfer , and bring quality products to market with lower risk and improved profitability. To learn more, download the solution brief.