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.
Why Partner with Curapath for End-to-End Development
Integrated Platform
From excipient synthesis to nanoparticle formulation and GMP manufacturing, Curapath offers a fully integrated CDMO platform under one structure, ensuring seamless coordination across development stages and efficient progression from pre-clinical to commercial supply.
Regulatory Expertise
Robust CMC and regulatory support aligned with FDA and EMA standards, enabling compliant development strategies, successful IND submissions and readiness for NDA and BLA filings.
Proven Manufacturing Track Record
More than 200 GMP batches manufactured and multiple ongoing clinical programs supported, demonstrating consistent delivery, operational reliability and long-term manufacturing capability.
Specialized in Non-Viral Delivery
Deep scientific expertise in lipid and polymer excipients, nanoparticle formulations (LNP and PNP) and advanced non-viral delivery systems, supporting next-generation therapeutics and biologics.
Technologies and Platforms Supporting Your Development
Curapath’s end-to-end CDMO services are built on specialized technology platforms for lipid- and polymer-based excipients and advanced non-viral drug delivery systems, enabling scalable, GMP-ready development from early-stage research to commercial manufacturing.
Lipid Nanoparticle (LNP) Platforms
Development and GMP manufacturing of lipid nanoparticle systems for nucleic acids and advanced therapeutics, supported by scalable formulation and controlled production workflows.
Polymer Nanoparticle (PNP) Platforms
Design and manufacturing of polymer-based nanoparticle systems enabling controlled delivery, enhanced stability and tunable pharmacokinetics.
Polymer and Lipid Excipient Manufacturing
GMP synthesis and scale-up of novel polymers, ionizable lipids and functional excipients supporting drug substance and drug product development.
Bioconjugation and Functionalization Technologies
Advanced conjugation and surface-functionalization strategies enabling ligand attachment, targeting and polymer-drug conjugation while maintaining critical quality attributes.
Our Core Technology Foundation
Our technology platforms are designed around scalability, reproducibility and regulatory alignment from the earliest development stages. By integrating advanced process design, controlled nanoparticle engineering and GMP-ready excipient manufacturing, we ensure that innovation translates into reliable clinical and commercial production.
Our Specialized Solution Platforms
In addition to our core technology platforms, Curapath develops specialized solution programs tailored to specific therapeutic modalities, delivery challenges and application-driven development needs.
Targeted Lipid Nanoparticles (tLNP)
Ligand-functionalized lipid nanoparticle systems designed to enable cell-specific or tissue-directed delivery, improving biodistribution and therapeutic precision for nucleic acid and advanced biologic programs.
Transfection Reagents
Non-viral alternatives for in vivo DNA delivery programs, supporting DNA vaccines, gene therapies and emerging CAR-T strategies with scalable and reproducible formulation approaches.
PEG-Free Shielding Lipids
Advanced shielding lipid technologies designed to improve nanoparticle stability, enable repeat dosing and overcome PEG-related limitations in LNP and tLNP systems.
PSar-Based Solubilizers
High-performance polysarcosine-based excipients developed to enhance solubility, stability and formulation performance for biologics, peptides and small molecules.
Polymer Conjugates
Polymer-drug conjugation platforms enabling controlled release, improved pharmacokinetics and enhanced therapeutic performance across oncology, antibiotics and immunomodulatory programs.
Polymer Coatings
Functional polymer coating technologies providing non-fouling or bioactive surface properties for medical devices and advanced biomedical applications.
Translating Innovation into Scalable Solutions
Our specialized solution platforms are designed to address specific therapeutic challenges while maintaining scalability, reproducibility and regulatory alignment. By integrating advanced lipid and polymer technologies with GMP manufacturing capabilities, we translate innovative delivery strategies into reliable clinical and commercial solutions.
Quality & Compliance
Rigorous GMP manufacturing aligned with FDA and EMA standards. Production follows each market’s regulatory requirements, including controlled-room environments for medical-device ingredients, ICH Q11-guided excipient development and GMP / ICH Q7-aligned drug-substance manufacturing. Dedicated QA and QC systems ensure validated processes and consistent batch quality
Accelerated Development
Integrated CMC, analytical and manufacturing workflows designed to shorten development timelines while maintaining technical robustness and regulatory alignment.
Risk Mitigation
Proactive process design and validation strategies to minimize scale-up risks and ensure seamless transition from pre-clinical to commercial manufacturing.
Process Excellence
Structured process optimization, continuous improvement and scalable production platforms engineered for reproducibility and long-term manufacturing performance.
Regulatory Integration
Our GMP Manufacturing Principles
Frequently Asked Questions
What is Curapath
Curapath is a European Contract Development and Manufacturing Organization (CDMO) specialized in non-viral drug delivery systems. We support biotech and pharmaceutical companies from early development through GMP-ready and commercial manufacturing, combining proprietary delivery components, in-house technologies, and deep expertise in complex formulation and CMC development.
What does an end-to-end CDMO service include?
An end-to-end CDMO service integrates development, formulation, analytical support, GMP manufacturing and regulatory alignment across all stages of the therapeutic lifecycle. At Curapath, this includes lipid and polymer excipient manufacturing, nanoparticle formulation platforms and scalable production from pre-clinical development through commercial supply.
Do you manufacture lipid and polymer excipients under GMP conditions?
Yes. Curapath provides GMP manufacturing and scale-up of polymer and lipid excipients, including ionizable lipids and advanced polymer chemistries, supporting drug substance and drug product development for clinical and commercial applications.
Do you support nanoparticle formulations such as LNP and PNP systems?
We develop and manufacture lipid nanoparticles (LNP), targeted LNP (tLNP) and polymer nanoparticles (PNP), combining formulation expertise with scalable and reproducible processes aligned with regulatory expectations.
Moreover we can also manafucture Lipid–polymer hybrid nanoparticles (LPHNs) and targeted LNP system
Can you support IND and NDA submissions?
Yes. Our integrated CMC and regulatory support includes preparation of documentation for IND submissions and assistance with NDA and BLA filings, ensuring alignment with FDA and EMA requirements throughout development and commercialization.
Do you offer PEG-free alternatives for nanoparticle systems?
Yes. We develop and manufacture PEG-free shielding technologies, including polysarcosine and zwitterionic lipid alternatives, designed to improve nanoparticle stability and enable repeat dosing strategies.
Find all our alternatives in our product catalog
Can you scale up from pre-clinical development to commercial manufacturing?
Our technology platforms are designed for seamless scale-up, ensuring that early-stage development processes translate efficiently into validated GMP manufacturing for clinical and commercial supply.
Right now Curapath is supporting both R&D developments, Clinical trials in different phases and suppliying commercially available products.
