RNA Manufacturing Articles

51. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

52. A "Hot Take" On mRNA Scale-Up 6/12/2024

    In the following multi-part “mini-series” of RNA industry “Hot Takes,” I share several aspects that jumped out at me from the BioPhorum ATMP Event — starting with several takeaways about mRNA scale-up.

53. The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing 6/10/2024

    This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.

54. Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing 5/29/2024

    Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

55. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

56. Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? 5/21/2024

    Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

57. Multidisciplinary mRNA: What Can We Learn From Other CGTs? 5/20/2024

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

58. How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing 5/15/2024

    QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.

59. 2 “Must-Haves” In mRNA CDMO Outsourcing Partnerships 5/13/2024

    In the final installment of this two-part series, Jain shares his assessment of the partnering landscape for mRNA therapeutic candidates. Though capacity has been a hot-button topic/need for other modalities in the ATMP space, his tips for evaluating CDMOs for mRNA therapeutics keep us aligned around the importance of capability and flexibility in outsourcing partnerships, especially when working with a nascent therapeutic modality.

60. "A Particular Set Of Skills:" Outsourcing Considerations For mRNA Therapeutics 5/6/2024

    In the first of this two-part article series, Jain offers us his observations on the growth of the mRNA outsourcing sector, as well as the most important learnings he’s gleaned from engaging and contracting CDMOs in this space — particularly in these “earlier” days of the RNA therapeutics industry.