RNA Manufacturing Articles

  1. Modular And Single-use Tech Driving The Future Of Biomanufacturing 11/14/2023

    BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.

  2. What Regenerative Medicine Manufacturers Have Been Waiting For 11/9/2023

    It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.

  3. Global Market Trends For Oligonucleotide APIs 9/28/2023

    Oligonucleotide APIs belong to a category of compounds that comprise short sequences of DNA or RNA. These compounds can be tailor-made to target an individual gene’s messenger RNAs. This article shares new market research, including a look at the drivers behind growing demand, different types of oligonucleotide APIs, and key players in the space.

  4. Guidelines For mRNA Drug Product Manufacturing And Quality Control 9/15/2023

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

  5. Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture 9/13/2023

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

  6. “Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry 8/7/2023

    The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming.

  7. Why RNA Is Good For Business 7/3/2023

    Early last year, Nutcracker Therapeutics landed a $170 million Series C to further its work developing an RNA drug development platform. Learn how scientist-turned Chief Business Officer Geoff Nosrati is lifting the company above the cacophony of companies rallying around the therapeutic potential of RNA.

  8. Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity 5/22/2023

    In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.

  9. 4 Risk Mitigation Strategies For mRNA Production 4/17/2023

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  10. Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned 3/29/2023

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.