OP White Papers - random

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

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

  2. White Paper: Spray Drying Biologics: An Alternative To Freeze Drying 10/16/2024

    Explore how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.

  3. Mycoplasma Contamination In Biopharmaceutical Manufacturing 2/9/2024

    Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.

  4. 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.

  5. EMA Support For Rare Disease Therapies 6/10/2025

    Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

  6. Digital Maturity In Life Sciences Quality And Manufacturing 6/17/2025

    Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

  7. Sustainability In Small Molecule API Manufacturing 11/7/2025

    Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.

  8. Is Mannitol Hemihydrate Detrimental To Protein Stability? 10/16/2024

    Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.

  9. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  10. Overcoming Barriers To Membrane Technology: Demonstrating Protein A Affinity Capture Quality, Process Similarity 3/25/2025

    Explore how the interchangeable use of Protein A membrane and resin media can streamline your bioprocessing workflows, ensuring efficient, scalable, and high-quality manufacturing from lab scale to full-scale production.