Insights On CONTRACT PHARMA MANUFACTURING

  1. Optimizing Contamination Control: Strategy Planning And Execution For Facility Compliance 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  2. Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny? 7/25/2025

    Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

     

  3. Guiding Principles For Process Development And IND Readiness 7/25/2025

    Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.

  4. Modernizing Your Way to Success In Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapy has evolved from a niche concept to a booming sector in just five years, with over 1,300 companies and growing momentum in innovation, investment, and regulatory approvals.

  5. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

    Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

  6. Together, Let's Sail Toward Success 7/23/2025

    Explore the promise and complexity of gene therapy and see how Cytiva empowers scientists to overcome challenges and accelerate life-changing treatments from lab to patient.

  7. Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap 7/23/2025

    As biopharma complexity grows, flexible CDMOs like Afton Scientific are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

  8. Analytical Procedure Development Following ICH Q14 7/23/2025

    Review how the new ICH Q14 guidance and AQbD principles can transform analytical method development into a more efficient, robust, and regulatory-ready process.

  9. Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety 7/23/2025

    Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

  10. Adapting rcLVV Assays For Commercial Manufacturing 7/22/2025

    Witness a validated dual-assay approach for sensitive, CGMP-compliant detection of replication-competent lentiviruses, enhancing safety and regulatory confidence in lentiviral vector manufacturing.