RNA Manufacturing Articles

41. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

42. RNase Control: An Overview With Market Trends 12/2/2024

    This article shares an overview of ribonuclease (RNase) control and some associated macro market research.

43. Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact 11/26/2024

    The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?

44. RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology 11/19/2024

    During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.

45. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

    The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

46. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

    Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

47. RNA Therapeutics: New Market Research 11/14/2024

    According to our new market research, the RNA therapeutics industry is predicted to exceed $31 billion by 2032. This article shares key findings and trends.

48. Lessons From The Past: How mRNA Can Thrive In The Evolving ATMP Market 11/4/2024

    Fortunately, as multiple presenters during the AGC CDMO Summit explained, there have been a few historical case studies of how the industries preceding us did (or didn’t quite) do the due-diligence they should have to trigger meaningful societal change. Not only do these case studies provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.

49. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

50. A Tale of Two Futures: Financial Trends Shaping The Advanced Therapies Space 10/25/2024

    In the first of this two-part article, I’ll share a few of the commercial nuances informing what the path forward may look like for all of us in the ATMP financial sector.