OP White Papers - random

  1. Analytical Techniques For Assessing Quality Of Therapeutic Proteins 6/5/2025

    Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

  2. Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration 7/7/2025

    Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

  3. Simplify CAPA In 7 Steps 9/20/2024

    Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

  4. Establishing Commercial Manufacturing Services For ADCs 6/3/2024

    Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

  5. 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.
  6. Continuous Manufacturing For API Breakthroughs 7/31/2025

    Observe how a compound library, designed for chemical diversity and lead-like properties, uses advanced filtering to improve hit discovery, speed hit-to-lead development, and boost early-stage small molecule drug discovery.

  7. Overcoming Challenges To High-Concentration Formulation Development 3/25/2025

    Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.

  8. How To Avoid Sticking And Picking In The Tableting Industry 9/23/2024

    Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

  9. The State Of Digital Maturity In Pharma And Medtech Manufacturing 9/20/2024

    Explore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.

  10. Navigating CMC Regulation For Plasmid DNA In Gene Therapy 5/28/2025

    Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.