Industry Insights

  1. The Growing Role Of MSCs In Regenerative Medicine 9/10/2025

    Mesenchymal stem cells (MSCs) show great promise in regenerative medicine, but scaling their production for clinical use is a key challenge that requires careful optimization and planning.

  2. Method-of-Treatment Patents: Increasing Value & Risk 12/27/2021

    Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. 

  3. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

  4. 2022 Outsourcing Trends In Biopharmaceutical Manufacturing 6/15/2022

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

  5. The 10 Phases Of An Effective CAPA 2/5/2020

    Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

  6. Pharmaceutical Company Innovation By The Numbers 4/6/2023

    Clarivate has published its 2023 list of the Top 100 Global Innovators, identifying the companies and institutions globally that have pushed the boundaries of technology and applied knowledge the furthest. To define “innovation” in this context, Clarivate uses global invention data, which includes patent applications and issued/granted patents.

  7. Transferring Potency Assays From Lab To GMP Production: Strategies For Success 3/6/2025

    With experience in managing assay transfers across diverse sources and development stages, we have identified five factors that can significantly impact the success of potency assay transfers.

  8. EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications 4/3/2020

    While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

  9. Leveraging The Right RNA Polymerase Enhance Capping Efficiency 6/10/2024

    By utilizing an engineered co-transcriptional capping RNA Polymerase, researchers can reduce the production of double-stranded RNA byproducts and enhance the functionality of mRNA therapeutics.

  10. Reduce Risks And Future-Proof Cell Therapies: Advanced Process Analytics 12/6/2022

    Given the complexity of cell therapies, most of the process and analytical development and GMP manufacturing elements should be coordinated with partners that have expertise, equipment, and facilities.