White Papers

  1. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

  2. 5 Steps To Design A Microbiological Performance Qualification For Facilities 4/21/2025
    Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
  3. Extractables And Leachables Assessment For Single-Use Systems 4/14/2025

    Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

  4. Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes 4/8/2025

    The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

  5. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection with expert CRO guidance.

  6. 8 Ways To Achieve Higher ROI In Quality 4/4/2025

    Is your company still using outdated methods for its QMS? It's time to evolve. Discover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth and innovation.

  7. Assuring Multipotency Of Human Mesenchymal Stem Cells (hMSCs) 4/4/2025

    Stem cell research has revolutionized tissue repair and regenerative medicine. Discover how mesenchymal stem cells play a key role and offer insights into connective tissue repair, immune response, and inflammatory diseases.

  8. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

    Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

  9. The 5 Ws Of A Human Factors Strategy 3/31/2025

    A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

  10. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.