RNA Manufacturing Articles

51. 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.

52. 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.

53. 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. 

54. 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.

55. 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    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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.

56. 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.

57. 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.

58. 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. 

59. 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.

60. 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.