Newsletter | August 12, 2026

08.12.26 -- Can Oligo Regulations Keep Up With Manufacturing Innovation?

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Advanced therapies get personal

What if medicines could be produced inside the body instead of manufactured outside it? Discover how advances in lipid nanoparticles and RNA delivery are helping scientists send genetic instructions directly to cells, opening new possibilities for in vivo genomic medicine and advanced therapeutics.

FEATURED EDITORIAL

Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?

Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future. 

Enhancing CGTs With Circular RNA-Based Gene Expression

While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.

The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production

In part three of this series, dive further into continuous manufacturing, AI, modular facilities, and the next RNA platforms reshaping therapy production, scaling, and delivery.

How Targeted Nanoparticles And Circular RNA Advance CAR-T Development

To overcome the short duration of therapeutic protein expression associated with mRNA, Sail Biomedicine has developed novel endless RNA constructs. Michael Lam, Ph.D., discusses its delivery mechanisms and an outlook for future applications.

INDUSTRY INSIGHTS

Lipid Nanoparticles For Pulmonary Delivery Of mRNA

Gain insight into how nebulized mRNA lipid nanoparticles show preclinical success in lung delivery, offering fresh momentum for inhaled gene therapies targeting respiratory diseases.

Current And Emerging Technologies To Optimize mRNA Manufacturing

Explore the benefits of using mRNA for vaccines and therapeutics, and how to address technical, intellectual property, and cost considerations when considering commercial production.

Complexing RNPs: Have You Established Your Clinical Acceptance Criteria?

Ensuring consistency and quality at every manufacturing stage is critical for CRISPR-Cas gene editing. To achieve this, the FDA recommends establishing well-defined acceptance criteria for RNP formation.

Pushing The Boundaries Of Chromatographic Separation

Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.

The Post-COVID Regulatory Landscape For mRNA-Based Therapeutics

As organizations adapt to evolving safety standards for mRNA, collaboration remains essential to navigate challenges such as regional requirements, dosing needs, and analytical complexities.

The Partnership That Built A Biomanufacturing Certification Program

This partnership with SCC launched a biomanufacturing program, building career pathways and community talent for Spokane’s growing life sciences and pharmaceutical manufacturing sector.

Manufacturing Strategies For mRNA Vaccines And Therapeutics

mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.

Quality In GMP IVT mRNA Development, Manufacturing, And Analytics

Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.

SOLUTIONS

Comprehensive Process And Formulation Development Services

Enabling The Next Generation Of Bio-Therapeutics

Biosafety Testing

Labscale Lipid Nanoparticle Production