End-to-End CDMO Services for Drug Development and GMP Manufacturing
From pre-clinical development through clinical and commercial manufacturing, Curapath supports the scale-up and production of advanced therapeutic drug delivery systems.
CDMO Services Across the Drug Development Lifecycle
Pre-Clinical
Working with Curapath provides access to deep scientific and technical expertise to support early-stage therapeutic development under robust quality and safety standards.
We deliver integrated pre-clinical development services combining chemistry, formulation, process and analytical development for advanced drug delivery systems, including lipid- and polymer-based therapeutics.
Our pre-clinical activities are designed to generate representative, scalable and well-characterized materials, ensuring early alignment with GLP toxicology studies and a smooth transition toward clinical and GMP manufacturing.
Synthetic Route Development: Development of efficient and scalable synthetic routes for small molecules, lipids, complex polymers and bioconjugates, with a strong focus on robustness, reproducibility and compatibility with future GMP manufacturing.
Process Development: Optimization of chemical and manufacturing processes to improve yield, purity and batch-to-batch consistency, while ensuring scalability, cost efficiency and alignment with environmental and regulatory expectations.
Formulation Screening and Development: Early-stage screening, design and optimization of polymer- and lipid-based drug formulations to assess performance, manufacturability and scalability, supporting informed candidate selection and smooth transition toward GLP and clinical development.
Analytical Method Development: Development of robust analytical methods to enable accurate characterization, identity confirmation and quality control of pre-clinical compounds, generating reliable data to support GLP studies and future regulatory submissions.
Pre-Clinical CMC and Pilot Batch Manufacturing for GLP Tox Studies: Early definition of CMC and development strategies combined with the manufacture of non-GMP pilot batches representative of future GMP material, intended for GLP-regulated toxicological, pharmacokinetic and efficacy studies, ensuring alignment between pre-clinical and clinical phases.
Pre-Clinical Development Services
Clinical Development and GMP Manufacturing Services
Clinical Development
Curapath supports clinical development through GMP-compliant manufacturing of lipid and polymer excipients, nanoparticle formulations and drug products for clinical trials, combining deep technical expertise with robust quality systems.
We develop, characterize and manufacture clinical materials following a science-driven and risk-based approach, ensuring that formulation, process and analytical strategies for non-viral drug delivery systems are aligned with regulatory expectations and clinical trial requirements.
Our integrated clinical services are designed to enable reliable clinical supply, support IND submissions and ensure a smooth transition from pre-clinical development to scalable GMP manufacturing.
Clinical Trial Material (CTM) Manufacturing: GMP manufacturing of drug substances and drug products for clinical trials, including lipid- and polymer-based excipients and formulations, ensuring reproducibility, quality and regulatory compliance for clinical supply.
Aseptic Fill and Finish: Aseptic fill and finish of liquid and lyophilized formulations under GMP conditions, supporting clinical trials with flexible formats, validated processes and qualified batch release.
Polymer and Lipid Synthesis and Scale-Up:GMP synthesis and scale-up of polymers, lipids and novel excipients, enabling consistent and reproducible manufacturing from laboratory scale to clinical-stage production.
Nanoparticle Formulation Process Development and Scale-Up: Development, optimization and scale-up of nanoparticle formulation processes for lipid- and polymer-based systems (LNP, PNP, PLGA-based nanoparticles, liposomes), ensuring robust, reproducible and GMP-ready manufacturing of LNP, PNP and related delivery platforms.
Advanced Drug Delivery Systems Development: Development and clinical manufacturing of advanced non-viral drug delivery systems, including lipid nanoparticles (LNP), polymer nanoparticles (PNP) and polymer conjugates, using innovative chemistries and controlled formulation strategies.
Analytical Method Validation: Development and validation of analytical methods together with ICH-compliant stability studies, ensuring accurate characterization, quality control and shelf-life definition of clinical materials.
Stability Studies: Conducting stability studies on polymer formulations under various conditions to determine their shelf life and optimal storage parameters.
Regulatory Documentation and CMC Support: Comprehensive CMC and regulatory support for clinical development, including preparation of documentation for IND submissions and alignment with regulatory requirements across major markets.
Quality Assurance and Quality Control: Robust QA and QC systems to ensure all clinical materials meet GMP standards, predefined quality specifications and regulatory expectations prior to release.
Process Characterization and GMP Validation: Characterization and validation of manufacturing processes to define critical process parameters, establish control strategies and ensure consistent product quality under GMP conditions.
Clinical Supply Chain Management: Management of clinical supply logistics, including packaging, labeling, storage and distribution of clinical trial materials, ensuring reliable and compliant supply to clinical sites.
Commercial supply of polymer and lipid excipients and nanoparticle formulations
Commercial
Curapath supports commercial manufacturing through fully integrated GMP services for lipid and polymer excipients, advanced drug delivery systems and drug substances, combining state-of-the-art facilities with robust quality and regulatory frameworks.
We enable a reliable transition from clinical to commercial scale by delivering validated, scalable and compliant manufacturing processes aligned with FDA and EMA requirements.
Our commercial services are designed to ensure consistent product quality, regulatory compliance and long-term supply continuity across global markets
Regulatory Documentation and Support: Preparation and support of CMC and regulatory documentation for NDA and BLA submissions, ensuring successful regulatory approval and readiness for commercial manufacturing under FDA and EMA standards.
Commercial Material Supply: GMP manufacturing of commercial-scale materials, including polymers, lipids and drug substances, ensuring consistent quality, scalability and long-term supply reliability.
Lifecycle Management: Post-approval lifecycle management including process optimization, change management, reformulations and continuous improvement to support long-term product performance and market supply.
Our 5
Manufacturing
Standards
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Curapath reduces production lead time through smart, optimized procedures. We implement seamless and phase-appropriate CMC development to ensure reliable pre-clinical and clinical product supply with an 100% batch compliance track record.
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The Curapath risk management approach leverages high-level expertise to ensure final product quality while complying with the regulatory requirements.
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