Cambrex Industry Insights

31. Digital Transformation In Regulatory: Achieving Excellence Virtually 1/24/2022

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

32. Balancing Cost Efficiencies In The Drug Development Process 1/24/2022

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

33. Assessing End-To-End Drug Development Partnerships 1/24/2022

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

34. Addressing Development And Manufacturing Upheaval 1/24/2022

    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.

35. Components Of An Effective Disinfectant Prequalification Strategy 1/24/2022

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

36. Demonstrating Control Over The Manufacturing Process: QbD Studies 1/24/2022

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

37. Pinpoint Manufacturing Steps That Require Tighter Control 1/24/2022

    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.

38. Route Development: Designing Synthesis For GMP Production 1/24/2022

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

39. Rapid Characterization Of Impurities 1/24/2022

    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.

40. Qualified Reference Standards: Setting The Standard For Product Quality 1/24/2022

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