OUTSOURCING ARTICLES
-
The Hidden Bottleneck In Advanced Therapies Isn't Science⦠It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
-
RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
-
How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation
Subtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
-
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends
As RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
-
A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
-
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026
Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Leveraging a partner experienced in controlled temperature GMP-compliant storage, secondary packaging/labeling, and kit production is critical to advance your CGT project to market.
-
Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.
-
Smaller biotechs are rethinking CRO partnerships, valuing speed, scientific access, flexibility, and transparent pricing over scale — driven by pandemic lessons and a sharper focus on operational fit.
-
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
-
Assimilate how advanced therapy supply chains are evolving toward patient-centric, risk-managed, digitally connected models to support scale, reliability, and regulatory confidence globally today.
-
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
-
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.