RNA Analytical/Quality Articles

  1. Ancient Molecule, Modern Medicine: The Science, Strategy, & Stakeholders Behind tRNA Therapeutics 7/22/2025

    As we all know well, “unearthing” our molecules’ potential poses numerous technical and business-related challenges for young biotech companies. Here, Werner and I continue our conversation, unpacking some of these internal and external challenges the company is navigating as it strives to bring tRNA to the commercial market.

  2. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

    Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

  3. Enzymatic Ligation: The Next Chapter In siRNA Manufacturing 7/11/2025

    During my three days at TIDES, I sat through several talks about the industry’s progress toward enzymatic ligation approaches for siRNA manufacturing. In the following article, I’ll share a few of the biggest takeaways I garnered from these different presentations, with a particular focus on the efficiencies the industry hopes such efforts unlock in the long-term. 

  4. Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1) 6/20/2025

    In my presentation, I argued that there are several lessons we can learn from Picasso that will also help our own industry mature. In the upcoming weeks, I plan to unpack these lessons, highlighting specific instances in which I see our industry taking these lessons to heart and making progress — starting here with lesson 1: Being Innovative Comes After We Master The Basics

  5. Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics 6/10/2025

    Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

  6. A Guide To Designing mRNA Medicines 6/10/2025

    A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.

  7. Designing Our Way Toward Circular RNA Medicines With AI 5/21/2025

    The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.

  8. A Road Map For PAT Monitoring And Control 5/8/2025

    Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

  9. EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines 5/6/2025

    The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

  10. 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.