RNA Supply Chain Articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. “To Thine Own [mRNA Product] Be True:” Shakespeare’s Guide To RNA GMP Principles 3/11/2024

   In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

9. 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.

10. “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).