RNA Outsourcing

OUTSOURCING ARTICLES

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.
Four Reasons You Should Choose Lyophilization for Your Next Project
Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing
Here, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”

OUTSOURCING VIDEOS

Mitigating Financial Risk Before Selecting An Outsourcing Vendor

Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.

Regulatory Confidence, Manufacturing Excellence

With decades of experience, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory confidence.

No Cells, No Limits To DNA Production: Inside Synthetic DNA

Here, we walk you through our groundbreaking, enzymatic DNA manufacturing process that enables the production of linear DNA templates for IVT mRNA synthesis — without the use of cells.

Mastering The Complexities Of Gene Therapy Document Writing

Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

An In-Depth Analysis Of CRO Operations And Impact On Drug Development

Get a full overview of the role CROs play in clinical trials and their impact on site selection, site monitoring, patient recruitment, managing data, and more.
Building Local Biomanufacturing Capacity In South Africa

Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
The Future Of CGT: Phase-Appropriate Plasmid DNA Manufacturing

Effective CGT development hinges on phase-appropriate manufacturing. Matching manufacturing rigor to the clinical phase ensures the right quality at the right time while reducing costs and accelerating timelines.
Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation

In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic

In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
Avoiding The Pitfalls Of LNPs And Complex Formulations

Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
Accelerated Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

More Outsourcing Resources

OUTSOURCING ARTICLES

OUTSOURCING VIDEOS

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

OUTSOURCING SOLUTIONS