OP White Papers - random

31. Nasal Vaccine Development, Manufacturing, And Device Selection 7/11/2023

    When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

32. Preclinical Immuno-Oncology Models For CAR T-Cell Therapy Development 5/21/2025

    The following preclinical IND-enabling oncology studies conducted by scientists at Aragen over the past 10 years highlight the role of robust preclinical models in advancing the fight against cancer.

33. 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.

34. Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity 2/14/2025

    A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

35. 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.

36. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

    Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

37. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

38. Leading European CDMO For Drug Product Manufacturing 6/2/2025

    As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

39. Modern Modeling Tools For Small Molecule Solid Dose Manufacturing 3/10/2025

    Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

40. Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies 12/13/2024

    Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.