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Learn How

Recipe lifecycle management for biopharmaceutical companies involves the management of processes and data associated with the development, scale-up, production, and continuous improvement of biopharmaceutical products. This includes the management of manufacturing recipes and analytical methods at different stages of the product lifecycle, ensuring a smooth, sustainable transition from development to commercial manufacturing.

The Challenges

Managing this complex lifecycle poses several challenges:

Collaboration and Communication: Recipe development and production often involve cross-functional teams. Effective collaboration and communication are essential to ensure that all stakeholders are aligned and informed about recipe changes and updates.
Data Integrity: Maintaining accurate and complete records of recipes and processes is crucial for product quality and regulatory compliance.
Scale-Up and Tech Transfer: Scaling up a biopharmaceutical production process from lab-scale to commercial production can be complex and challenging.
Regulatory Compliance: Biopharmaceutical companies are subject to strict regulatory guidelines, and they must adhere to Good Manufacturing Practices (GMP) and other regulatory requirements.
Process Variability: Biopharmaceutical manufacturing processes often have inherent variability. Process control and monitoring to maintain product consistency and quality is critical- especially for biologics and other sensitive products.
Sustainable Imperative: Limit pharmaceutical manufacturing's impact on the environment, human health, ecosystems and resource availability

The Solution

Recipe Lifecycle Management ensures the uniform and reliable dissemination of product, equipment, and process information across the entire lifecycle, limiting the sustainability impact by allowing efficient definition of sustainable targets and the ability to assess environmental metrics of the complete manufacturing operations definition. This approach offers a structured methodology spanning various departments, facilitating the industrialization of sustainable manufacturing processes. It also presents a data-driven blueprint for an industrial setup, drawing from both laboratory and pilot phase data, to configure equipment and assign them to executable process steps.