Newsletter | October 8, 2025

10.08.25 -- Building Platform Analytics For mRNA Therapeutics

SPONSOR

 

Process development and formulation services for pDNA and mRNA

Cytiva now offers process development and formulation services for plasmid DNA (pDNA), messenger RNA (mRNA) and lipid nanoparticles (LNPs), delivering end-to-end support for early-stage biotechs and biopharmas seeking to accelerate development, de-risk scale-up, and prepare for clinical milestones. Customers retain full ownership of their process knowledge and can move from process development to cGMP manufacturing with confidence and speed.

FEATURED EDITORIAL

New Group Wants 'Phase-Appropriate' Thinking To Retire

Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

 

The Pros Of Receptor-Based Targeting & Polymer Delivery

In this Advancing RNA clip, Jim Martineau, of Nosis Bio, and Sean Kevlahan from Nanite Bio, walk us through some of the benefits of working with receptor-based targeting and advanced polymer systems — each of which are emerging as promising alternatives to lipid nanoparticles.

 

Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics

As many of the presentations throughout the two-day USP quality forum revealed, we’re doing what we must to understand the benefits and the limitations of our methods. Yes, this is painstaking and expensive work. But understanding our methods is also one of the critical steps toward a future in which we can rely upon platform analytical procedures and — channeling our inner Britney Spears — say “[Ooo], I did it again!” to the regulatory agencies for each of the subsequent molecules in our pipelines.  

 

INDUSTRY INSIGHTS

 

Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing

Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

 

Assigning IR Absorption Bands For RNA Building Blocks Using MMS

Explore the power of Microfluidic Modulation Spectroscopy (MMS) in identifying RNA base signatures. This study analyzes vibrational modes of A, G, C, and U, revealing insights into electronic environments and molecular interactions.

 

Why Bioanalysis Needs To Break Free From Manual Bottlenecks

Bioanalysis remains one of the most persistent bottlenecks in drug development, with CRO's displaying inefficiencies that are no longer operational nuisances but strategic liabilities.

 

Elevating mRNA Manufacturing Toward GMP-Readiness

The mRNA Technology Transfer Program empowers low- and middle-income countries (LMICs) with scalable vaccine production. Learn about a partnership that drives mRNA innovation and sets a global blueprint for equitable health access.

 

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

 

Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials

How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.

 

Future Proof Your Process Scale Workflow

Discover how you can future-proof your process scale workflow, from starting bases to tangential flow filtration.

 

Comparison Of HIC Monolithic Support For Sample Displacement Of pDNA

Competing adsorption in sample displacement chromatography utilizes the chromatographic resin's binding capacity more efficiently and increases the chromatographic step's productivity. Learn about three monolithic chromatographic supports and their applicability for sample displacement of pDNA.

SPONSOR

 

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development. Gain insights across cell culture, therapy development, and CGT manufacturing, and learn from world-renowned leaders Bobby Gaspar (Orchard Therapeutics), Christof Von Kalle, (Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

SOLUTIONS

mRNA Raw Materials: A Clear Path To Market

Jet-Based Nanoparticle Formulation At Research Scale

Comprehensive mRNA Solutions