Industry Insights

51. CBER Takes On More Oversight Of Biologic Biosimilar Master Files 8/11/2020

    For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.

52. What The Antibiotic Shortage Teaches Us About API Supply Disruptions 7/17/2020

    The COVID-19 pandemic has highlighted the need to reevaluate API manufacturing partners, and we may see companies shift to a more regionally diverse supply chain, including an appropriate mix of localized and global capabilities to meet specific market needs.

53. mRNA Manufacturing: Overcoming CMC Development Challenges 6/15/2022

    A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.

54. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

55. Operationalizing Cell & Gene Therapy: Challenges And Solutions 9/22/2020

    Cell and gene therapies require operational excellence, complex manufacturing processes, and enormous investment, among other challenges. This article highlights some of these challenges and presents real-world evident solutions.

56. Navigating The Highs And Lows Of Early Phase Clinical Trials 12/2/2025

    Convert uncertainty into opportunity by mastering scientific rigor, operational agility, and strategic foresight. Partnerships and proactive regulatory planning are essential for minimizing risk.

57. Evolution In Prostate Cancer Diagnostics Creates New Opportunities For Medtech 4/17/2019

    This article provides a high-level review of some existing prostate cancer diagnostic assays used for screening, risk stratification, and monitoring treatment response. It also discusses opportunities for development in prostate cancer diagnostics.

58. Unlock The Potential Of GPEx® Lightning: Accelerate Your HEK Cell Line Development 5/8/2026

    Cut HEK cell line development to four months with 30% higher titers. GPEx® Lightning delivers faster, scalable biologics manufacturing. Access the full summary now.

59. Tips For Viral Vector Production 4/16/2024

    Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

60. Scaling Up Your Methods With USP <621> - Part 2: Hardware 9/22/2023

    Learn about the hardware changes that allow for scaling and modernization of chromatographic methods and how mismatching particle size and liquid chromatographic systems can result in poor performance.