RNA Supply Chain Articles

1. Therapeutic Oligonucleotides: Regulations & Quality Standards 5/20/2022

   Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

2. The RNA Therapeutics Supply Chain: A Platform of Relationships 2/13/2024

   Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

3. 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.

4. “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA 4/24/2024

   It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

5. 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.

6. 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.

7. Assessing Quality Of mRNA Vaccines: Key Considerations 10/12/2022

   To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.

8. 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.

9. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

   The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

10. 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.