OP White Papers - random

1. Innovation In Filtration 3/18/2025

   Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

2. Placing Drug Strategies On A Solid Foundation For Success 3/18/2025

   Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

3. Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars 2/9/2024

   The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

4. Analytical Techniques For Characterization, Release, And Stability Testing 4/28/2025

   Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.

5. Optimizing Reference Standards For Your Biopharmaceutical 1/29/2024

   By addressing considerations for a comprehensive reference standard strategy, manufacturers can ensure the integrity of biopharmaceuticals, ultimately paving the way for better patient outcomes.

6. 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.

7. Current Strategies For Enhancing Bioavailability 6/23/2025

   Explore key strategies for enhancing bioavailability of poorly soluble drug compounds, including spray drying, particle size reduction, and lipid-based formulations supported by solid-state analysis.

8. Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility 10/16/2024

   The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

9. The Key To Viral Vector Success 11/11/2024

   Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

10. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.