OP White Papers - random

  1. Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies 5/5/2025

    Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

  2. What FDA CRLs Reveal About E&L 2/18/2026

    FDA feedback shows E&L gaps still delay approvals. This preview flags common issues — from unknown compounds to weak tox data — and offers ways to strengthen E&L approaches and cut regulatory risk.

  3. 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.

  4. Facilitate Handling Of Bulk Powders With Dry Granulation 8/11/2025

    Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.

  5. Streamline Your AAV Process With A Production Platform 10/6/2025

    AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.

  6. Developing Pulmonary Dosage Forms For Complex Molecule Delivery 9/23/2025

    Discover how next-generation inhalation technologies can transform pulmonary drug delivery and unlock new therapeutic possibilities for a wide range of respiratory diseases.

  7. Accelerating The Development And Production Of High-Quality bsAbs 3/7/2024

    Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.

  8. Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy 2/6/2026

    The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.

  9. Liposomal And Nanoparticle Technology 9/3/2025

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

  10. Pharmaceutical Spray Drying – Technology And Applications 1/21/2025

    Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.