RNA Outsourcing Articles

1. The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future 8/20/2025

   There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.

2. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

   Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

3. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

4. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

5. Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture 4/15/2025

   No matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.

6. The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?" 3/5/2025

   During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

7. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

   Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

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. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

   Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

10. Shifting Sands Scales: Manufacturing Considerations For Small-Scale mRNA Production 9/30/2024

    Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. In the first of this two-part article, I outline a few of these important manufacturing and outsourcing considerations that must accompany our shift to smaller scales.