OP White Papers - random

31. 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.

32. 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.

33. Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies 5/5/2025

    Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.

34. 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.

35. RNA Nanoparticle: Formulation, Process, And Characterization 10/22/2024

    Explore the current state-of-the-art in RNA nanoparticle formulation, examining the technologies and strategies used to optimize RNA delivery for preclinical and clinical development.

36. Ready To Demystify Organoids? 7/1/2025

    Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.

37. 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.

38. The 5 Ws Of A Human Factors Strategy 3/31/2025

    A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

39. 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.

40. Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing 4/24/2024

    Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.