Supporting mRNA Developers from Process Design to GMP Manufacturing

Struggling with variability, compliance or scalability in your RNA workflow?

We support developers working with mRNA and lipid nanoparticles (LNPs) from early product design through to GMP manufacture. As one of the few UK-based CDMOs with licensed RNA capabilities, we offer a fully integrated model that brings together process development, analytical support and GMP manufacturing within a single facility.

Our team understands the practical challenges of developing mRNA therapies. We work closely with clients to ensure every stage, from IVT to fill finish, is designed to strike the right balance between speed to clinic and future success — enabling faster entry into trials without compromising long-term development.

mRNA manufacturing is complex, but with the right strategy and support, it can be designed for both clinical viability and long-term success.

mRNA-based therapies demand tight control across multiple stages, from in vitro transcription through to LNP encapsulation and final fill. Each step can impact quality and yield, while also introducing compliance challenges in a continually evolving regulatory environment.

Issues with IVT performance, analytical variability or supply chain resilience can slow development and significantly increase costs. We understand these challenges and focus on building GMP-ready processes that meet the practical demands of clinical development.

Our approach combines scientific rigour with practical delivery to keep programmes moving forward with confidence.

Common Pitfalls in mRNA Process Development

We work with developers who have faced challenges including:

Poor process robustness across IVT, purification and LNP steps

Unclear release strategy and limited stability data

Analytical gaps, especially around encapsulation efficiency and potency

Batch-to-batch variability due to uncontrolled process parameters

GMP requirements considered too late in the development cycle, increasing project length and cost

What You Gain with eXmoor

How We Help mRNA Developers Progress with Confidence

As a single-point solution provider, we offer integrated services within one licensed facility. Our service model brings together consultancy, process development, analytical support and GMP manufacturing, making it easier to move from early design through to clinical supply.

With flexibility to support small-scale or multi-batch programmes, we help clients reduce risk and accelerate progress by streamlining workflows and minimising unnecessary handover steps.

Here’s how we support you:

Process development (IVT, mRNA purification, encapsulation and formulation)

Tailored to your mRNA product with optimisation support to improve quality and yield.

Drug product manufacture (LNP encapsulation, formulation and sterile fill finish)

Carried out in a controlled GMP environment to ensure batch integrity and compliance.

RNA drug substance manufacture under MIA(IMP) licence

Enabling clinical batch production within a licensed, quality-assured framework.

Integrated analytical development and in-process testing

To help validate product quality, characterise critical attributes and meet regulatory requirements.

Clinical batch production

Supported by experienced QPs and regulatory experts to ensure smooth release and documentation.

Access Our Latest mRNA Info Sheet

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Discuss Your mRNA Programme With Us Today

Whether you’re developing a new mRNA therapy or looking to transfer an existing process into GMP, we can help. Contact us to speak with our team about your development strategy, facility needs or manufacturing goals.

Request a Proposal