OP White Papers - random

  1. Quality By Design: The Importance Of Reference Standards In Drug Development 8/1/2024

    Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.

  2. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  3. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

  4. Is Sustainability The Key To Agile Biopharma Manufacturing? 3/18/2025

    In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

  5. Advancements In Microbial Manufacturing Of Biopharmaceuticals 9/26/2024

    Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

  6. Leak Rate Testing for Freeze Dryers: A Scientific Approach 10/16/2024

    Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.

  7. Cell Line Development: The Linchpin In Biotherapeutic Development 1/4/2024

    Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.

  8. 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.

  9. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  10. Utilizing MAPPs For An Enhanced Assessment Of Immunogenicity 1/4/2024

    Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.