Accelerate your pDNA, mRNA, and LNP process development

Advance quickly to clinical trials

You need to quickly build processes, validate lead candidates and delivery systems, and scale for launch. Cytiva’s process development services—covering plasmid DNA (pDNA), messenger RNA (mRNA), and lipid nanoparticles (LNPs)—are designed to help you do just that.

How we can help with nucleic acid process development

Whether you're getting ready for Investigational New Drug (IND) filing or scaling up for GMP manufacturing, our team becomes an extension of yours. With global infrastructure, deep process expertise, and seamless project management we will help you to hit your next milestone—and the ones after that—with confidence.

Why work with us to develop your pDNA and mRNA process?

Collaboration that enables you

We align on your objectives and keep everything transparent—scope, cost, and progress—through dedicated project and technical leads. Once complete, we will hand off all process knowledge to you – to empower your teams and give you control of the next steps.

Manufacturing-ready processes

Build robust, scalable processes using industry-standard equipment backed by deep industry know-how and application data. Our integrated approach gets your mRNA-LNP ready for tech transfer and clinical production.

Speed and flexibility

Accelerate development, cut risk, and control costs with our integrated workflows and holistic support. You choose whether to outsource or build your own manufacturing platform – based on what works best for your global strategy.

Experience full support across your workflows

Process development and scale-up

for pDNA and mRNA

Formulation screening and development

for LNPs and other delivery systems

Analytical and bioassay services

to confirm your critical quality attributes (CQA) and monitor quality

Tech transfer and manufacturing

support to CDMOs or your teams

experience full support across workflows

Benefit from specialized expertise in pDNA and mRNA processes

pDNA process support

From process development to scale-up and tech transfer - we support upstream and downstream pDNA workflows including:

Parameter screening and design of experiments (DoE) studies
Fermentation, lysis, and clarification
Chromatography and filtration
Linearization and formulation
Analytical methods for identity, purity, and potency

Compared with a three-step chromatography process, our optimized two-step purification process has shown:

60% reduction in purification time
90% reduction in buffer consumption

mRNA process support and LNP formulation

We offer comprehensive mRNA and LNP process services including:

in vitro transcription (IVT) synthesis and co-transcriptional capping
Tangential flow filtration and chromatography
Lipid nanoparticle formulation with freedom to operate (FTO)
Custom analytics for CQAs, such as 5’ cap, polyA tail, dsRNA, and potency

mRNA process support and LNP formulation

Ready to accelerate your pDNA, mRNA, or LNP process?

Talk to a specialist

Flexible scale and scope

Whether you’re looking for a small study, in-process assays, or an end-to-end process – we define project scope based on your needs. After the project ends, you can bring your process in-house, use your own CDMO, or work with Aldevron. You can also choose our CDMO for:

pDNA fermentation: 50 mL to 50 L; inquire about 200 L
mRNA IVT: 300 mL; inquire about 1000 mL

Nucleic acid process development success stories

Fast-track to GMP

Replicate Bioscience collaborated with Cytiva to accelerate their self-replicating RNA vaccine program, achieving GMP manufacturing and IND filing within 18 months.

Rapid mRNA scale-up

COVID-19 programs scaled mRNA processes in less than eight weeks.

FDA-ready workflows

Advanced mRNA services enabled FDA trial approvals through optimized IVT, purification, and analytics.

Explore related services

Regulatory consulting

Feel confident with our help to build your regulatory strategy, prepare for GMP readiness, and respond to regulators.

Analytical testing

Free up precious time by letting us handle your in-process sample testing for pDNA and mRNA.

Take related training courses

Gain useful skills and know-how through hands-on and virtual courses led by instructors with industry expertise. Topics include:

Plasmid DNA production and purification

mRNA IVT and purification

LNP formulation and analytics

Let’s move your molecule forward

Reach key milestones faster – with fewer surprises and more control. Whether you need testing, scaling, or fine-tuning, we’re ready to support you.

Talk to a process specialist

Shop in your local currency and language

Speed up pDNA, mRNA, and LNP development

Choose your support level and where to manufacture – at a CDMO or your site.