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Pre-GMP mRNA and LNP Development

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Accelerate Your Path to Market with Vernal’s Pre-GMP mRNA and LNP Development Expertise

The Pre-GMP (Good Manufacturing Practice) steps of an mRNA program set the stage and the probabilities of success for safe, effective, and compliant drug products. Vernal’s Pre-GMP mRNA and LNP development services streamline process development, optimize scalability, and ensure rigorous quality standards, enabling drug developers to navigate the complexities of regulatory requirements with confidence. By leveraging our expertise, you can identify and mitigate risks early, enhance product quality, and accelerate your journey to market—transforming innovative ideas into life-changing therapies faster and more efficiently than ever before.

Drug Developers can utilize our Pre-GMP mRNA and LNP development services at key stages, including Material Supply for Analytical Method Establishment and Qualification, Stability Studies to assess product performance under varying conditions, Non-GLP Toxicology Studies for potential early safety evaluations, and Pivotal Preclinical Studies to generate essential data for regulatory submissions and clinical trial preparation. Our services provide the solid foundation needed for a successful and efficient path to market.

Key Benefits

Risk Mitigation

Pre-GMP activities help identify and address potential issues early in the development process. By rigorously testing formulations and processes, companies can reduce the likelihood of costly errors and regulatory setbacks.

Quality Assurance

Using a QbD approach to establish robust manufacturing protocols during the Pre-GMP phase ensures that quality is built into the product from the start. This proactive quality approach can carry over to a GMP project with a strong quality foundation.

Streamlined Transition to GMP

By starting your journey to a toxicology study or clinical batch with a Pre-GMP project, you’ll experience a seamless transition to GMP manufacturing. Preparing for success will lead to faster regulatory approvals and quicker market entry.

Cost Effective

Get your toxicology or GMP manufacturing started with a budget-friendly Pre-GMP project. You’ll also save money by addressing challenges early, reducing costs associated with rework, failed batches, and compliance issues. Investing in Pre-GMP can save your company money in the long run.

Pre-GMP mRNA Development | Vernal Biosciences

mRNA development, analytics, and manufacturing—under one roof—to deliver high purity drug substance, drug product, and intermediates. | Vernal Biosciences

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Comprehensive Pre-GMP Solutions for Effective mRNA Development and Drug Manufacturing

Process Development	Establishment (Potential Critical Process Parameters (pCPPs) at Target) Full Development (Design of Experiment (DoE))
GMP-Representative Manufacturing Process	Scalable Unit Operations Process Closure Animal Origin Free (AOF) Process Considerations Elevated Segregation Controls Primary Cell Bank Hold Time Demonstration
Process Documentation	Preliminary Facility Fit (for Technology Transfer (TT) Projects) Raw Material Review Packets Process Description(s) Batch Records Process Closure Risk Assessment Project Specific Protocols Protocols for Production of Product for Good Laboratory Practice (GLP) Tox Studies Protocols for Production of E. Coli Primary Cell Banks
Quality	Establish initial specifications for Drug Substance/Drug Product (DS/DP) from Target Product Profile/Quality Target Product Profile (TPP/QTPP) Creation of template Certificates of Analysis (CoA(s)) Method Establishment & Qualification
Investigational New Drug (IND) Submission Support	Provision of Information for Submission Participation in Pre-IND Consultation Program
High-Quality mRNA & LNP	Custom mRNA Manufacturing LNP-Formulated mRNA

Start or Seamlessly Transfer Pre-GMP Projects to Vernal | Vernal Biosciences

Start or Seamlessly Transfer Projects to Vernal

Begin your project with Vernal or seamlessly transfer your existing project to us and say
goodbye to constant delays in development, juggling multiple vendors, dealing with unclear
processes, and the persistent worry of sacrificing quality to meet deadlines.

Ready to bring innovative therapies to patients faster?

With our expert Pre-GMP services, you’ll streamline processes, enhance product quality, and ensure regulatory compliance, all while minimizing risks. Don’t wait—contact us today to explore how we can help you transform your ideas into life-changing therapies and get them to market faster than ever before!

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It’s been very helpful to have a group that’s actually responsive and interested in trying out something, providing a continual effort to improve our mRNA.

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Co-Founder & CEO, Repair Biotechnologies