OP White Papers - random

  1. 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.

  2. Molecular Properties Of PROTACs And The Relationship To Formulation Design 3/4/2025

    Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

  3. Set Your Cell And Gene Therapy Program Up For Success From Day One 9/25/2024

    Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

  4. Phase-Appropriate Approaches To Manufacturing And Testing 3/14/2025

    Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

  5. Nose To Brain (N2B) Drug Delivery – Benefits And Challenges 11/20/2024

    Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).

  6. Factors To Consider While Selecting Stoppers For Lyophilized Vials 10/16/2024

    Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.

  7. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  8. Liposomal And Nanoparticle Technology 9/3/2025

    Specializing in oncology, anti-infective, and complex formulations, Pfizer Melbourne provides manufacturing services for sterile dosage forms.

  9. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  10. Driving Operational Excellence Using Machine Learning 12/13/2024

    Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.