RNA Analytical/Quality Articles

  1. One Unspoken Issue With The FDA's Platform Designation 9/19/2024

    Subjectivity and hearsay will no doubt play a big role in how we approach the FDA's Platform Designation guidance moving forward, and I daresay these hard to mitigate factors will complicate our relationship with this designation in the future. 

  2. FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers 9/5/2024

    As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.

  3. Two "Spicy" Takeaways On The FDA's Platform Designation Guidance 8/29/2024

    Over the past few weeks since the guidance was released, I’ve spent some time listening to industry conversations and reading the guidance and related articles. In the following series of articles, I’ll share a few general impressions and (slightly spicy) thoughts I’ve been mulling over in response to the draft guidance. 

  4. Developing & Manufacturing Oligonucleotides: An Overview 8/22/2024

    An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.

  5. Bridge RNAs: Principles, Applications, And Challenges 8/1/2024

    Bridge RNAs are structured noncoding RNAs that facilitate programmable recombination between target and donor DNA, enabling precise genomic rearrangements. A significant advantage is their modularity.

  6. From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing Partnerships 7/24/2024

    In the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.

  7. A "Hot Take" On mRNA Critical Process Parameters 7/17/2024

    Bushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production.

  8. Innovation Advances In mRNA Medicine 7/9/2024

    The post-pandemic mRNA pipeline surge has led to a substantial investment in innovation. Let’s look at nonamplifying mRNA, saRNA, and circRNA.

  9. A "Hot Take" on Personalized mRNA Medicines 6/20/2024

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

  10. What Does FDA's Draft Platform Guidance Mean For CGT Companies? 6/17/2024

    Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.