FEATURED APPLICATION CONTENT

• Ensuring Resilience: How Life Science Is Reshaping Supply Chains In Response To COVID-19

  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.

• Digital Transformation In Regulatory: Achieving Excellence Virtually

  As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

• Balancing Cost Efficiencies In The Drug Development Process

  Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.

• Assessing End-To-End Drug Development Partnerships

  As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

• Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?

  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.

• Components Of An Effective Disinfectant Prequalification Strategy

  Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

• Successful Control Strategies – Part 2

  Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

• Successful Control Strategies – Part 1

  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.

• Route Development: Designing Synthesis For GMP Production

  The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design. Chemists must optimize each intermediate reaction and balance economic, regulatory and time constraints.

• Rapid Characterization Of Impurities

  Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

• Qualified Reference Standards: Setting The Standard For Product Quality

  Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

• Peptide Synthesis: Delivering Cost-Effective Strategies

  For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.