Industry Insights

  1. The Environmental Impact Of Biopharma Continuous Manufacturing: Part II 8/22/2022

    Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.

  2. Design And Packaging Advantages For Cell And Gene Therapy Drugs 9/3/2024

    With the increasing demand for cell and gene therapies, CZ nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

  3. Emerging Trends In mAbs Manufacturing In 2025 And Beyond 2/11/2025

    Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

  4. The Path To Regulatory Approval For AOCs 4/14/2025

    The development and manufacturability of antibody-oligonucleotide conjugates hinges on understanding and overcoming intricate chemistry and technical challenges.

  5. Automating Fill And Finish: Five Steps For Scaling Success

    Discover how a solution can help therapeutic providers gain tighter control of their processes and deliver higher-performing treatments compared to manual methods.

  6. Cleanroom Data Analytics To Consider When Setting Up Environmental Monitoring 7/16/2024

    Learn about innovative software that addresses the need of pharmaceutical manufacturing plants to centralize and trend data from various sources important to environmental monitoring systems.

  7. Can Real-World Evidence Transform Healthcare? FDA Indicates Yes 11/19/2021

    Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

  8. Establishing A Working Range For Effective MSC-EV Dose 12/28/2021

    In this blog we explore the current state of MSC-EV dosing in completed and ongoing clinical trials, discuss the factors that affect MSC-EV dose, including MSC-EV quantification methods, and establish a target ‘working range’ for MSC-EV dose in humans.

  9. How To Avoid Form 483s For Biopharma Software Validation Failures 8/17/2022

    The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.

  10. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.