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 Expert
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.
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.
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.
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.
* We can start process and analytical development for GMP projects in Q3 2023. Transfer into GMP manufacturing facilities in Q1 2024.
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.
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.
We are a single organization with a global network to deliver CDMO services across all stages of the molecule value chain.
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
Here, we explore lipid-based RNA therapeutic development, specifically application opportunities and the performance-defining parameters.
Learn more about the essential aspects and strategies of successful drug development and commercialization of lipid-based drug products.
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