Insights On Drug Development

31. Gene Therapy In-Use And Device Compatibility Studies 7/28/2025

    Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

32. Next Generation Sequencing In Viral Safety Testing 7/25/2025

    Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

33. AAV Viral Titering Using Nanoplate-Based Digital PCR 7/22/2025

    Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

34. New Purpose-Built Facility For Large-Scale Sterile Fill/Finish Operations 7/17/2025

    Expanding capacity for late-phase clinical and large-scale commercial small molecule and biologic drugs, a new facility boosts sterile fill/finish capabilities.

35. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

36. Accelerating Gene Therapy Development For NEDAMSS 7/15/2025

    Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

37. The Role Of CDMOs In Supporting Generic Drug Development 7/15/2025

    Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.

38. Elevating Downstream Process Development With Real-Time Data Monitoring 7/11/2025

    Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

39. Enhancing Viral Clearance Prediction And Process Optimization 7/11/2025

    MockV technology enables early, in-house viral clearance assessment, helping biopharma developers improve process robustness, reduce costs, and enhance safety before GMP manufacturing begins.

40. Balancing Speed, Quality, And Digital Transformations 7/11/2025

    Explore how CDMOs can leverage strategic agility, scale flexibility, and overcome challenges to drive success in a rapidly evolving pharmaceutical landscape.