Featured Editorial

  1. Lessons From The Past: How mRNA Can Thrive In The Evolving ATMP Market 11/4/2024

    Fortunately, as multiple presenters during the AGC CDMO Summit explained, there have been a few historical case studies of how the industries preceding us did (or didn’t quite) do the due-diligence they should have to trigger meaningful societal change. Not only do these case studies provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.

  2. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

  3. A Tale of Two Futures: Financial Trends Shaping The Advanced Therapies Space 10/25/2024

    In the first of this two-part article, I’ll share a few of the commercial nuances informing what the path forward may look like for all of us in the ATMP financial sector.

  4. Tune Therapeutics On Clinical Readiness, Technology Adoption 10/18/2024

    Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

  5. How Platform Technologies Are Shaping The Gene Therapy Landscape 10/18/2024

    Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

  6. A "Flight Plan" For Achieving These 3 mRNA Development Milestones 10/18/2024

    Here, in the final installment of this three-part series, I’ll share the panelists’ greatest learning experiences and regulatory advice (so far) on what we should be looking out for as we strive to achieve three big milestones: Entering the clinic; implementing advanced manufacturing technologies into our processes; and standardizing our manufacturing platforms.

  7. Are We Actually Living In An mRNA Regulatory "Desert?" 10/11/2024

    Fortunately for us, the panel shared a few important reminders for us all as we continue to navigate mRNA in a variety of different therapeutic applications and, perhaps, as we explore the implementation of advanced manufacturing technologies in our mRNA-LNP manufacturing processes. In the second of this three-part article series, I walk through one big takeaway I had from this panel’s conversation about the current state of mRNA regulatory affairs.

  8. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

  9. Shifting Sands Scales: Manufacturing Considerations For Small-Scale mRNA Production 9/30/2024

    Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. In the first of this two-part article, I outline a few of these important manufacturing and outsourcing considerations that must accompany our shift to smaller scales.

  10. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.