With You On
Every Step
Learn More About Each Step of Our Process:
Pre-Clinical
Working with our team will provide you with the scientific expertise necessary to ensure your therapeutic product meets the required standards of quality and safety.
We can provide comprehensive analytical method and process development services for early-stage therapeutics, including formulation screening, manufacture and testing.
By utilizing our services for pre-clinical development, sponsors can be assured that their therapeutic is being developed in the most efficient and cost-effective way.
Synthetic Route Development: Expert development of efficient and scalable synthetic routes for small molecules, lipids, complex polymers and conjugates.
Process Development: Optimization of chemical processes to enhance yield, purity, and scalability while minimizing cost and environmental impact.
Formulation Development: Optimization of polymer-based drug formulations to enhance stability, bioavailability, and targeted delivery.
Analytical Method Development: Development of robust analytical methods to ensure precise characterization and quality control of preclinical compounds.
GLP Tox Batches and Preliminary Testing: Representative of future GMP material to be used for GLP regulated Toxicological and efficacy testing.
Clinical
Our team of experts bring decades of experience in the development and manufacturing of biopharmaceuticals and complex therapeutics. By leveraging our team’s knowledge, experience, and specialized equipment, we ensure the required standards are being met and your drug product is being delivered to you in a timely manner.
Curapath releases and certifies GMP-compliant batches after appropriate characterization and verification of the manufacturing processes. The characterization approach is tailored to the specific needs of each product type, such as excipients, drug substances, polymer conjugates, and sterile liquids. This process includes sterilization validation, analytical method qualification, and the appropriate requirements and approach as per applicable GMPs.
This includes developing, validating, and implementing analytical methods to ensure the quality and consistency of both the drug substance and drug product. Additionally, we can support your team on the selection of stabilizers and excipients, as well as appropriate primary and secondary packaging materials. Once the drug substance and drug product have been developed, Curapath supports the manufacturing and testing of the clinical trial material.
Clinical Trial Material (CTM) Manufacturing: Aseptic Fill and Finish capabilities to produce GMP grade clinical trial materials involving polymer and lipid-based formulations.
Polymer and Lipid Synthesis and Scale-Up: Custom synthesis and scale-up of novel polymers and lipid novel excipients for drug delivery systems, ensuring reproducibility and scalability from lab to clinical scale.
Advanced Drug Delivery Systems: Development and manufacturing of advanced drug delivery systems such as Lipid Nanoparticles (LNP), Polymer Nanoparticles (PNP), Polymer Conjugates, using innovative chemistries.
Analytical Method Validation: Validation of analytical methods tailored for polymer-based drug formulations to ensure precise characterization and quality control.
Stability Studies: Conducting stability studies on polymer formulations under various conditions to determine their shelf life and optimal storage parameters.
Regulatory Documentation and Support: Comprehensive regulatory support, including preparation and submission of IND applications and assistance during regulatory inspections.
Quality Assurance and Control: Rigorous QA and QC processes to ensure all clinical materials meet GMP standards and predefined quality specifications.
Process Characterization and Validation: Development and validation of scalable processes to ensure consistent production quality and robust control strategy.
Clinical Supply Chain Management: Efficient management of the clinical supply chain, including logistics, inventory control, and distribution of polymer-based clinical trial materials.
Commercial
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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