Nanoparticle Formulation, Manufacturing & Fill & Finish Services
Curapath provides end-to-end CDMO services for the development and manufacturing of lipid nanoparticles (LNPs), polymer nanoparticles, PLGA-based delivery systems, and targeted nanoparticle formulations. We support programs carrying a broad range of therapeutic payloads, including mRNA, siRNA, saRNA, plasmid DNA, proteins, peptides, gene editing systems, vaccines, and small molecules.
From early formulation screening and process development to analytical characterization, scale-up, GMP manufacturing, aseptic fill & finish, and CMC support, our multidisciplinary team helps sponsors accelerate development while building robust, scalable, and regulatory-ready manufacturing processes for clinical and commercial success.
Preclinical Services
Developing a successful nanoparticle formulation requires much more than selecting the right excipients. From the earliest formulation studies to GMP-ready manufacturing processes, every stage influences product quality, scalability, and clinical success.
Curapath provides integrated development services for lipid nanoparticles (LNPs), polymer nanoparticles, PLGA-based nanoparticles, and targeted delivery systems. Our multidisciplinary team supports formulation design, process optimization, analytical development, scale-up, and technology transfer to accelerate the path from discovery to clinical manufacturing.
Formulation Screening
Evaluate different formulations, excipients, lipid compositions and polymer systems to rapidly identify the optimal nanoparticle formulation for your therapeutic payload.
Formulation Optimization
Optimize particle size, PDI, encapsulation efficiency, stability, composition and process parameters to obtain robust, reproducible formulations ready for scale-up.
Targeted Nanoparticle Engineering
Develop targeted nanoparticles through surface functionalization, ligand conjugation and advanced bioconjugation strategies for tissue- or cell-specific delivery.
Process Development & Scale-Up
Transfer laboratory formulations into scalable manufacturing processes using microfluidics and other advanced mixing technologies while maintaining CQAs and reproducibility.
Analytical Characterization
Develop analytical methods to characterize nanoparticle physicochemical properties, encapsulation efficiency, release profile, stability and critical quality attributes.
Preclinical Manufacturing
Produce preclinical batches under controlled conditions to support proof-of-concept studies, IND-enabling programs and technology transfer toward GMP manufacturing.
GMP & Commercial Manufacturing Services
Curapath supports the seamless transition from development to clinical and commercial manufacturing through integrated GMP-compliant CDMO services. Our capabilities cover process scale-up, technology transfer, GMP manufacturing, aseptic fill & finish, and CMC and regulatory support, ensuring robust, scalable, and reproducible manufacturing processes for nanoparticle-based therapeutics.
Our GMP manufacturing capabilities include:
- Clinical and commercial GMP manufacturing of lipid nanoparticles (LNPs), polymer nanoparticles, PLGA-based systems, and targeted nanoparticle formulations.
- Scalable manufacturing processes, supporting batch sizes from process development to bulk production of up to 10–20 L, depending on the formulation and manufacturing platform.
- Aseptic fill & finish into multiple primary packaging formats, including vials, prefilled syringes, cartridges, bags, and bulk drug product.
- Technology transfer and process validation to ensure reproducible scale-up and manufacturing robustness.
- Comprehensive analytical release testing, stability studies, and quality control in accordance with GMP requirements.
- CMC and regulatory support, including technical documentation, manufacturing sections for IND, IMPD, NDA/BLA and MAA submissions, risk assessments, comparability studies, and support throughout regulatory interactions.