Lipids and LNP Formulation Contract Services
We Simplify Your LNP Therapy Development
As part of our Millipore® CTDMO Services offering, we pave the way for robust, 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 their LNP-based 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. Choose from our GMP-ready, fully connected services from lipid manufacturing, lipid nanoparticle formulation and manufacturing, and Fill and Finish.
Our Track Record
30+
Years combined track record in Lipids and LNP manufacturing
50+
Individual projects successfully delivered in synthesizing lipids
6
Commercial drug products manufactured
Preclinical
Our technical experts support the journey from the initial concept through custom lipids, 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 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 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
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
Global facilities built to guide you when you are ready to scale.
A highly connected CDMO network to ensure speed, scalability, quality, and flexibility for lipids, LNP formulation and manufacturing, and Fill-Finish.
Our manufacturing sites for our Portfolio Lipids, including Large Scale Lipid Production and our Early Formulation Screening Service
Our Center of Excellence for research-grade mRNA
Our Center of Excellence specialized for synthesizing high-quality Portfolio and Custom Lipids
Our Center of Excellence for the manufacturing of Lipid Nanoparticles (incl. Fill and Finish)
Manufacturing Site for Portfolio and Custom Lipids and Process Development for Liposomes and LNPs
Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Services include analytical development, cell banking, cell line characterization, viral clearance, drug substance and drug product release testing, as well as rapid methods.
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.
Related Webinars
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