RNA Manufacturing

MANUFACTURING ARTICLES

Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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.
2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA Therapeutics
As RNA therapeutics mature, 2026 will reward execution over novelty. Delivery, data-driven design, and modality specialization will determine which RNA platforms scale clinically and commercially.
A New Space Race: Reclaiming Efficiency In The mRNA Industry
It goes without saying that efficiency in drug development is tantamount — especially when it comes to getting much-needed clinical data. So, when I asked Allan Shaw about the ongoing trends he anticipates seeing more of in 2026, he immediately pointed to the increasing prominence of overseas development, particularly in nations like Australia and China.
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

MANUFACTURING VIDEOS

Minimate™ EVO Tangential Flow Filtration System: Simplified Continuous Diafiltration

Learn about an easy to assemble and simple to use solution for laboratory TFF applications, the assembly of the system, and how to perform a continuous diafiltration.

An mRNA Wish-List: What Regulatory Developments Would Make Life "Easier?"

Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic.

Addressing mRNA's Scalability And Supply Challenges

Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.

MES Apps Built For Speed And Seamless Integration

Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

Efficient, Scalable Purification Of mRNA By Affinity Chromatography

Increasing demand for mRNA as a therapeutic product requires efficient, scalable purification methods. Here, a monolithic stationary phase is used to purify mRNA from a capping mix of Luc2 RNA.
Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges

Learn more about the challenges that arise during the synthesis, purification, and encapsulation of mRNA.
The Sponsor's Clinical Development Handbook For Gene Therapy Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
A Guide To mRNA Vaccine Production And Manufacturing Services

Find out more about the key steps for successful mRNA vaccine production, which encompasses mRNA manufacturing, and ways that you can save valuable time from the start of manufacturing.
Enhanced mAb Production With High-Intensity Perfusion CHO Medium

Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
Exploring Osmolality As A CQA Within RNA Therapeutics

Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation optimization to cryopreservation techniques.
From Data To Decisions: Accelerating Your mRNA Drug Development With Analytics

To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.

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