Industry Insights

  1. Translating Study Reports – A GLP Draft Guidance 5/6/2024

    The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

  2. Quality Management Process Improvement 2/7/2023

    With the constant introduction of new technologies, employees are regularly overwhelmed by organizational complexity and information overload. Learn how to achieve simplicity in quality management, facilitate change, and more.

  3. Experimental Methods For Microorganism Challenges On OWBA 2/17/2020

    While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

  4. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

    Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

  5. A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs

    Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

  6. Can Assumption-Free Batch Modeling Eliminate Processing Uncertainties? 11/14/2016

    Monitoring batch processes to ensure the highest level of quality is imperative. While periodic batch process control is the traditional approach to managing consistency end quality, it is recipe-driven. 

  7. Supporting The Unique Needs Of Your Sterile Injectable

    Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed.

  8. 4 Skills An Exceptional Project Manager Can't Survive Without 7/22/2020

    Project manager can mean many different things to many people. To some it means passing a PMI-accredited test and being knighted into project management. To others it means running cross-functional meetings, issuing and following up on minutes and action items, and managing GANTT charts. And to others it means meeting key project milestones and budgets.

  9. Organ-Chips And Organoids: Better Together 2/13/2024

    Combining organoids with Organ-Chips enables the development of more accurate human biological models. Learn how these technologies are opening the door for new experimental approaches and more.

  10. Full Control: Binary Blend Feeding A Liquid Chromatography Process, Pt. 2 3/25/2021

    Learn about how booster modules can address pressure variation challenges that disrupt automated blending systems in liquid chromatography processes.