With You On

Every Step

From Pre-Clinical to Clinical, and Commercial, we support you in the scale-up and production of your therapeutic drug.

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.

List of Capabilities:

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.

List of Capabilities:

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

Curapath’s expertise in Quality and Compliance in addition to state-of-the-art facilities are our core strengths. We will support your success in commercial application, meeting the latest FDA/EMA Quality Standards and regulatory requirements. With our commitment to quality, you can trust Curapath as your trusted partner for GMP Manufacturing.
List of Capabilities:
Regulatory Documentation and Support: Curapath’s guidance will ensure the success of your NDA/BLA application submissions. As a GMP-certified CDMO company, we guarantee passing pre-approval inspections conducted by regulatory authorities at our clinical and commercial manufacturing facilities.

Commercial Material Supply: Verify a consistent transition from clinical-scale to commercial-scale manufacturing, ensuring GMP compliance and scalability.

Lifecycle Management: Post-market surveillance and product support. Product improvements and reformulations.

Our 5
Manufacturing
Standards

1

Quality
At Curapath, we manufacture our products under rigorous quality standards. Our dedicated QC and QA departments ensure full compliance with applicable GMP regulations. Our facility is EMA GMP certified, and our products adhere to the strictest approval criteria.

2

Speed to Market

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.

3

Risk Mitigation

The Curapath risk management approach leverages high-level expertise to ensure final product quality while complying with the regulatory requirements.

4

Excellence
Curapath systematically applies agile methodologies to ensure continuous improvement, meet key project milestones, maintain budgets, and reduce costs whenever possible

5

Regulatory Requirement
We offer expert technical advice and regulatory-ready documentation to support your CMC sections for New Drug Applications (NDAs), Drug Master Files (DMFs), Investigational Medicinal Product Dossiers (IMPDs), Biologics License Applications (BLAs), and Investigational New Drug (IND) applications.

Interested in our Services?