Insights On Regulatory Compliance

  1. 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.

  2. Using Robotics In The ATMP Space 7/18/2023

    With regulatory requirements and GMP recommendations trending towards less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.

  3. How To Prepare For An Inspection: 8 Tips For Success 3/15/2024

    To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.

  4. Cutting-Edge Automation Revolutionizing Cell Line Development 8/1/2023

    Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.

  5. Modernizing Compendial SEC Methods For Biotherapeutics 4/16/2024

    Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.

  6. Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma 3/22/2023

    Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.

  7. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

    Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

  8. Lessons Learned From Implementing The FDA's CSA Guidance: Part 3 – Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies that they were expecting to realize from the new guidance. This series identifies several issues found during CSA implementations and how to avoid them.

  9. Genome Integrity Analysis Of Adeno-Associated Viruses (AAVs) 11/8/2022

    Learn about how RNA 9000 Purity & Integrity kit with ssRNA ladder allows for the assessment of genome size and purity of AAV regardless of the serotype.

  10. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.