Curapath is a leading polymer and lipid manufacturing company offering end-to-end solutions for therapeutic development, specializing in CDMO services. Our state-of-the-art facilities enable GMP manufacturing of polymer and lipid-based therapeutics, providing proven scale-up capabilities, analytic development, and a comprehensive CMC package, including:
- Preclinical Development
- Technology Transfer
- GMP Manufacturing
- Drug Product Formulation, Fill & Finish services to support clinical development
- Method Development, Validation and ICH
- Stability studies
- CMC Regulatory support for IND & BLA submission
For drug substance (DS) manufacturing, we specialize in kg-scale GMP production of polymers and lipid excipients, including polymer-conjugate DS with a scalable option of up to 6 kg per batch for commercial stage supply.
Regarding formulation capabilities, our lipid nanoparticle (LNP) and polymer nanoparticle (PNP) services are optimized for screening and production of RNA and DNA delivery solutions. We offer support from development to commercialization, and our NanoScaler Knauer equipment is utilized for formulation and scale-up development, ranging from mL to L scale. This technology, proven in the formulation of LNPs for large-scale manufacturing of SARS-CoV-2 vaccines by BioNTech/Pfizer, allows us to transition seamlessly from R&D batches to GMP mRNA-LNP batches while maintaining rigorous standards.
Finally, we have CDMO capabilities for formulating and scaling up development, especially considering our Fill & Finish services, which are well-suited for small to medium programs like Gene and Cell Therapies and Orphan Drug trials.
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Curapath North America
One Broadway
Cambridge, MA, 02142
United States
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Curapath
Av. Benjamin Franklin 19
Paterna, Valencia, 46980
Spain
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