OP White Papers - random

  1. CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products 3/5/2025

    Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

  2. Intro To USP <1062> - What It Is And Why You Should Use It 7/20/2023

    Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

  3. Revolutionizing Particle Characterization With Image Analysis And ML 9/27/2023

    The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

  4. Innovation In Filtration 3/18/2025

    Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

  5. ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The Journey 6/28/2024

    Learn how ISO 21973, a vital standard for ensuring safe and reliable transport of cell and gene therapies, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.

  6. Preclinical Evaluation Of Vaccines And Antivirals In RSV Challenge Rodent Models 6/10/2025

    Here, we present multiple case studies utilizing clinically relevant mouse and rat models to evaluate key characteristics of potential RSV therapeutics.

  7. Building Local Biomanufacturing Capacity In South Africa 2/11/2025

    Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

  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. Placing Drug Strategies On A Solid Foundation For Success 3/18/2025

    Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

  10. SMB Technology: Optimizing API Purification 6/13/2025

    Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.