RNA Supply Chain Articles

1. mRNA Vaccines: Key Considerations For Development & Manufacturing 4/4/2022

   As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

2. What Violin Making Can Teach Us About mRNA Therapeutic Quality 8/8/2022

   Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

3. Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault 10/7/2022

   What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.

4. Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control 1/30/2026

   Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

5. Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward 6/27/2025

   Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

6. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

   The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

7. 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.

8. 5 Critical Regulatory Topics To Watch In The Oligo Sector 7/16/2026

   Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.

9. Defining The RNA Therapeutics Industry In 2023 1/16/2023

   Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

10. The Expanding Patent Landscape For RNA-Based Therapeutics 11/16/2022

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.