RNA Manufacturing Articles

81. This Digital Twin Approach Aims To Optimize ATMP Production 9/25/2024

    Manufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.

82. Strategies To Address FDA CMC Trends For mRNA Therapies 9/24/2024

    A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.

83. 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. 

84. Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing 9/12/2024

    A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.

85. How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies 9/10/2024

    This article discusses how cell and gene therapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes.

86. Wish SUS Cost Less? Survey Says Your Peers Do, Too 9/6/2024

    BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

87. 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.

88. 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. 

89. 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.

90. Is This The Hardest Question Facing mRNA Therapeutics Makers? 8/18/2024

    As I’ve been reminded on a few different occasions, there is a difficult truth we may need to wrap our brains around in certain situations: Just because we can make an mRNA therapy for an indication, doesn’t necessary mean we should — or that the patient population will necessarily want it or be able to access it.