RNA Manufacturing Articles

51. 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.

52. End-To-End mRNA DS And DP Manufacturing Processes 7/10/2024

    This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

53. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

54. 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.

55. 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    Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance.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.

56. 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.

57. 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.

58. 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.

59. 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.

60. 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.