mRNA & LNP Contract Testing, Development, & Manufacturing Services
Responding to Patients Needs by Getting mRNA-Based Vaccines and Therapeutics on the Fast Track
As part of our Millipore® CTDMO Services offering, we pave the way for robust, integrated, and consistent processes along all stages from pre-clinical to commercialization. Bringing together our capabilities, technical expertise, and regulatory know-how, we enable our clients to achieve their goals— to get mRNA-based vaccines and therapeutics on the fast track and change the life of patients.
With Millipore® CTDMO Services we offer customized services to help clients accelerate their projects, mitigate risks, and expedite time to market – all the way from mRNA through lipids and lipid nanoparticles (LNP) to final Fill and Finish.
Talk To an ExpertOur Track Record
20+
Years combined track record in mRNA, Lipids and LNP manufacturing
10,000
Fold less pDNA required through next generation PCR based mRNA manufacturing
50+
Individual projects successfully delivered in synthesizing lipids
6
Commercial drug products manufactured
6+
Highly connected sites ensuring speed, scalability, quality, and flexibility
Preclinical
Our technical experts support the journey from the initial concept through mRNA synthesis, custom lipids, and screening and optimizing lipid nanoparticle (LNP) formulations for nucleic acid payloads.
Clinical
The technology transfer and scalability of the process to clinical GMP manufacturing is crucial. With Millipore® CTDMO Services, our team supports in scaling up and bringing your mRNA-LNP based drug program to the clinic, focusing on process efficiency as well as achieving regulatory compliance.
Commercial
Ensuring compliance to GMP standards regarding manufacturing, quality, safety, and efficacy is essential for the mRNA-LNP based therapeutics and vaccines journey to commercialization. Our experts help maintain the speed clients need by supporting risk assessment and management efforts and by adhering to quality requirements to accelerate time to market.
Our Offering
mRNA
We specialize in the production of fully customized, functional mRNAs and provide full technical support from project design and sequence optimization to data for investigational new drug (IND) dossiers. With our proven PCR-based workflow, mRNA manufacturing is highly reproducible, and the final product has excellent properties.
- Next generation PCR-based process for high quality mRNA
- Fully customized mRNA manufacturing
- Preclinical to GMP commercial scale - from mg to kg*
* We can start process and analytical development for GMP projects in Q3 2023. Transfer into GMP manufacturing facilities in Q1 2024.
Lipids
We are highly specialized in synthesizing top-quality, GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet our client’s specific needs.
- High quality synthetic products
- Flexibility with custom and portfolio offering
- Small to large scale GMP lipids – from grams to tons
Lipid Nanoparticles (LNP)
With Millipore® CTDMO Services we support pioneers in bringing their API (mRNA, siRNA, cas9RNA, etc.) to patients. From preclinical to clinical and commercial manufacturing, we use 20 years of manufacturing experience to make client projects successful.
- Formulation development via high throughput screening from multiple lipid libraries and process optimization
- In-house transfer to GMP
- Preclinical to GMP commercial scale from ml to several hundred liters
- In-house transfer from LNP manufacturing to Fill Finish
- Batch volumes < 1L to 1,200L
A Global Footprint
We are a single organization with a global network to deliver CDMO services across all stages of the molecule value chain.
A highly connected CDMO network to ensure speed, scalability, quality, and flexibility for mRNA, lipid, and LNP manufacturing.
Our Center of Excellence for Late Clinical & Commercial mRNA, manufacturing sites for our Portfolio Lipids, including Large Scale Lipid Production and Early Formulation Screening Service
Our Center of Excellence for Early Clinical mRNA
Our Center of Excellence specialized for synthesizing high quality Portfolio & Custom Lipids
Our Center of Excellence for the manufacturing of Lipid Nanoparticles (incl. Fill & Finish)
Manufacturing Site for Portfolio & Custom Lipids and Process Development for Liposomes & LNPs
Related Technical Resources
- Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines
Here, we explore lipid-based RNA therapeutic development, specifically application opportunities and the performance-defining parameters.
External Resources
- Successful Drug Development with Synthetic Lipids - Critical Aspects and Strategies
Learn more about the essential aspects and strategies of successful drug development and commercialization of lipid-based drug products.
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