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 advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.
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See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
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Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.
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Fragmented national regulations for pricing, customs, and reimbursement demand tailored supply chain strategies. Adapting to country-specific hurdles is essential for product integrity and patient access.
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Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
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Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.