With a comprehensive software integration this specialty biopharmaceutical group created a highly connected environment for documentation in quality, R&D, and manufacturing.
A European specialty pharmaceutical business deployed a fully integrated, closed-loop document management system that also addresses the quality and compliance requirements of regulatory bodies.
Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.
As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.
Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.
As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.
Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.
Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.
Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.
With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.