OUTSOURCING ARTICLES
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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.
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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.
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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.
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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.
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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.
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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
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Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
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CROs are not just facilitators but strategic innovators essential for delivering new therapies to patients efficiently and safely.
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Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
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Ensure fast, reliable, temperature-controlled logistics with a global infrastructure designed to protect critical biologic materials and keep development programs running smoothly and on schedule.
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Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.
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Consolidating logistics, cryopreservation, and storage eliminates handoffs and risk. This single-platform approach creates the consistency needed for global compliance and growth.
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Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.