The Early Advantage For mRNA | mRNA Research Services

Developing mRNA treatments requires expertise in process development and LNP encapsulation for small biotech companies. Lonza’s mRNA Research Services simplify this by providing end-to-end support, from mRNA synthesis to Lipid Nanoparticles (LNP) formulation - helping you reduce costs and accelerate development.

Even if you haven’t considered mRNA for your protein, our experts can guide you through its potential.

Specialized CDMO For mRNA And LNP Development

As a small biotech company, you will need to engage with CMC experts who have a strong background in addressing the complexities of mRNA process development and manufacturing, as well as proven experience with LNP encapsulation.

In this situation, a specialized Contract Development and Manufacturing Organization (CDMO) such as Lonza can provide you with an experienced team and offer you an integrated mRNA and LNP development solution. With our new mRNA Research Services offer, you can come to us with just the protein that you want to encode as mRNA. Then, we will carry out all or a selection of CMC research activities for you and deliver the mRNA/LNP that you need for your in vivo animal studies and other pharmacological testing.

Even if you have not thought about applying your protein as an mRNA molecule, do not hesitate to contact us - such a switch may help you greatly reduce development and manufacturing costs. Lonza mRNA Research Services offer you an easy approach to simplify and accelerate your mRNA/LNP project.

What is mRNA?

mRNA is an exciting and significant new modality for the treatment and prevention of various diseases, offering many advantages over traditional modalities.

In most applications, the mRNA is encapsulated in LNP to protect it from degradation, reduce immunogenicity, and deliver it into the target cells.

mRNA Research Services

Our mRNA Research Services encompass the activities listed below. They can either be booked as an end-to-end solution, or as a tailor-made offering including only the service(s) that you need.

Services Offered:

mRNA Backbone Development: Providing an mRNA backbone with full freedom to operate.
Optimized mRNA Sequence Design: Designing an optimized mRNA sequence for your protein with a focus on manufacturability, stability, and protein expression through in silico sequence optimization.
Small-Scale Manufacturing: Producing microgram-range quantities of multiple mRNA constructs selected based on in silico sequence optimization. The manufacturing process can utilize either all-natural nucleotides or various modified uracils.
Physicochemical Testing: Assessing mRNA constructs for integrity, dsRNA content, and early stability.
Protein Expression Testing: Evaluating the protein expression profile and duration of mRNA constructs.
Immunogenicity Testing: Conducting tests on both innate and adaptive immune responses of mRNA constructs in human ex vivo immune cells.

Based on the data obtained above, our experts will recommend the most suitable mRNA construct for pharmacological testing.

Next Steps:

Research Use Only (RUO) Material Manufacturing: Producing 100–120 mg of RUO material for the selected mRNA construct.
Physicochemical Testing of RUO Material: Conducting an extensive range of tests, including endotoxin and bioburden analysis.
Potency Testing of RUO Material: Ensuring the efficacy of the selected mRNA construct.

Our comprehensive research services are designed to support your mRNA/LNP project efficiently and effectively.

LNP Encapsulation Research Services

Our LNP encapsulation research services are available as single services or as a complete package.

LNP Services Offered:

Standard Lipid Pre-Mixtures: Providing standard lipid pre-mixtures for LNP manufacturing for specific applications (e.g., liver delivery or prophylactic vaccines).
LNP Encapsulation: Encapsulating RUO mRNA manufactured by Lonza (see above) or other nucleic acids provided by you using the selected lipid pre-mixture.
Analytical Testing: Conducting extensive analytical testing on RUO LNP-encapsulated nucleic acids, including:
- Size/PdI
- Encapsulation Efficiency (EE)
- Integrity
- Lipid Content/Identification/Purity
- CryoEM imaging
- And more

Comprehensive LNP Analysis and Characterization:

Potency Testing: Assessing the functional effectiveness of the LNP formulation.
Stability Testing: Evaluating the shelf-life and degradation profile of the LNPs.
In Vivo Testing: Investigating biodistribution to understand how the LNPs behave in biological systems.

These tests provide a complete understanding of your product from initial production to final-stage evaluation.

We will tailor the offer to your requirements, so you can decide which steps you prefer to outsource to us and which you prefer to keep in-house.