RNA Outsourcing Articles

1. 2 “Must-Haves” In mRNA CDMO Outsourcing Partnerships 5/13/2024

   In the final installment of this two-part series, Jain shares his assessment of the partnering landscape for mRNA therapeutic candidates. Though capacity has been a hot-button topic/need for other modalities in the ATMP space, his tips for evaluating CDMOs for mRNA therapeutics keep us aligned around the importance of capability and flexibility in outsourcing partnerships, especially when working with a nascent therapeutic modality.

2. “A Particular Set Of Skills:” Outsourcing Considerations For mRNA Therapeutics 5/6/2024

   In the first of this two-part article series, Jain offers us his observations on the growth of the mRNA outsourcing sector, as well as the most important learnings he’s gleaned from engaging and contracting CDMOs in this space — particularly in these “earlier” days of the RNA therapeutics industry.

3. A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers 4/19/2024

   Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.

4. ARW’s ATMP Manufacturing Must-Reads (ST. PATRICK’S DAY EDITION!) 3/14/2024

   Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

5. Comparability Considerations For mRNA Product Development 2/28/2024

   Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

6. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

   To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

7. Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024? 1/8/2024

   2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.

8. How Strategically Partnering With Academia Supports Biotech R&D Goals 9/14/2023

   For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.

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’s Global mRNA Manufacturing Strategy: A Closer Look 3/27/2023

    In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.