Regulatory

  1. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

  2. Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here? 5/3/2021

    There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

  3. The Impact Of Water Activity Testing On Tablets And Capsules

    Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.

  4. An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data 5/2/2023

    Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.

  5. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing 3/10/2023

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.

  6. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

    Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

  7. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

    Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  8. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.

  9. Container Closure Integrity Testing Method Development

    Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

  10. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

    The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.