Precision Drug Delivery Starts Here
Curapath’s expertise in the development and manufacturing of lipids and polymers, combined with our experience in nanoparticle formulation and manufacturing, makes Curapath the right partner for developing your therapeutic.
Curapath supports all stages of development from proof-of-concept to preclinical, clinical and commercial-scale GMP manufacturing. We help solve even the most complex drug delivery challenges.
We provide unmatched technical and analytical expertise in the custom design, development, and end-to-end GMP manufacture of polymer and lipid-based drug delivery systems for cell, gene therapy, and vaccine delivery.
We deliver hands-on guidance from preclinical development through commercial-scale GMP manufacturing – a knowledgeable partner you can trust to move fast, manufacture smart, and provide support through your drug development journey, accelerating your speed to clinic.
The advantage you need
Curapath’s End-to-End Services
We apply innovative creative thinking to
solve your drug delivery challenges.
We establish a robust, scalable process, implement analytical methods, and manufacture non-GMP pilot batches.
Progress toward IND filing smoothly; from prototype optimization to GLP tox studies and GMP production of drug substance and product for clinical trials.
We offer comprehensive services for commercial scale manufacturing, quality assurance and regulatory processes to bring products to market.
We specialize in the synthesis of polymer and polyamino acid drug conjugates and lipid and polymer nanoparticles.
We Develop Delivery Systems for Your Therapeutic Payload
We Develop Delivery Systems for Your Therapeutic Payload
We Provide Precision, Scalability and Flexibility From Start to finish
We Get it Done: Analytical Testing & Quality
In parallel with development of a polymer best suited for your application, we establish phase-appropriate and validated analytical methods suitable for characterization and quality control. These qualified methods support cGMP batch testing and includes compendial verification of methods following guidelines established by the International Council for Harmonization (ICH).
Curapath's analytical experts offer
- Routine characterizations
- In-process and quality control
- Indentity, quantitative, and limit tests
- Impurity profiles
- Analysis according to current monographs (e.g., Ph. Eur., USP)
- Method development and validation
- Comprehensive cGMP documentation and release certificates
InstrumENts & ASSAYS
- HPLC, IC
- Precision Balances
- Equipment for microbiological control
Lipid and polymer nanoparticle characterization
- Particle Size, Distribution, Zeta Potential – Malvern DLS
- API Identity and Concentration– RPIP
- API % Encapsulation – Ribogreen
- API Ratio – SEC
- Total API (RNA) Purity – Fragment Analyzer
- Lipid Identity and Concentration– UPLC-ELSD/CAD
- Appearance, Viscosity, Osmolality, pH, VIC – USP
- Endotoxin, Bioburden, Sterility, SVP – USP
- Raw Material ID – RPIP
Polymer & Lipid Excipients
(Bulk solid release, In-Process Control)
- Raw Material ID – RPIP
- Lipid Identity and Purity – UPLC-ELSD/CAD
- Polymer Purity, MW and PDI – SEC-RI-MALS
- MW & DP by End Group Analysis – HPLC-MS-UV
- Residual Solvents – USP
- Water Content – Karl Fischer
- Enantiomeric excess – HPLC-MS-UV
- Cleaning Verification/Validation – HPLC/TOC
Fill & Finish
We support you through all stages of clinical development. Small batch capabilities to meet clinical trial study needs. Formats vial, PFS, Bottles, Single-Use Bags
- Capability: 2,000 vials per batch
- Vials (up to 50 mL)
- Syringes (1 mL – 10 mL)
- Bottles (10 ml-1 L)
- Single-Use Bags (200 ml – 5 L)
- Batch size ranges from 1 liters to 20 liters
- Execute terminal sterilization as an alternative to filter sterilization
- Testing services pre- and post- fill & finish
- Release & stability testing, packaging & labeling
- Batch certification by a Qualified Person
- Administration routes:
- Intravenous, Intramuscular, Subcutaneous, Oral, Topical
We are currently authorized to manufacture both pre-filled syringes and oral liquids and the aseptic filtration of polymers classified as excipients.
Quality Assurance & Regulatory Support
Meet Our Team
VICENT J. NEBOT, Ph.D.
Vicent is the Chief Technology Officer of Curapath. He brings more than 15 years of experience in the field of nanomaterials and drug delivery systems in both industry and academic settings, having co-authored more than 40 publications (including articles, book chapters and patents) in the field, and been awarded several grants as co-PI. Before his time at Curapath, he was Research Collaborator at Centro de Investigación Príncipe Felipe (CIPF). Vicent is an expert in polypeptide-based systems, soft materials, supramolecular chemistry, and physico-chemical characterization with a special focus on CMC development of drug nanomedicines and their regulatory aspects. Vicent obtained his Ph.D. degree in Chemistry and Material Science, funded by Procter & Gamble, from Universidad Jaume I de Castelló in 2012. After a post-doctoral period of 3 years at Polymer Therapeutics Laboratory, headed by Dr. Maria J. Vicent, Vicent joined PTS as a researcher awardee of Torres Quevedo Spanish Ministry Program. He also participated in MIT Sloan School of Management’s Entrepreneurship Development Program.
Nicolas is the Chief Finacial Officer for Curapath. Nicolas is a seasoned financial executive with 15+ years of experience in dynamic and fast-paced environments across multiple sectors and countries. He started his career at PricewaterhouseCoopers Paris before joining DB Schenker Rail as Head of Finance & Accounting. More recently, he served as a Chief Financial Officer and Board Member of Telamon Shipping, Dragon Investors, Nice Tech, and MDCV. Nicolas has developed a deep understanding of financial reporting, budgeting, forecasting, and strategic planning and has acquired expertise in optimizing and automating processes to improve efficiency and reduce costs. In addition, he has extensive experience building and leading high-performing cross-functional teams, managing complex projects, driving change initiatives, and implementing best practices. Nicolas obtained his MSc in Business Administration at Kedge Business School in 2006.
MARK E. MAXWELL
Mark is Senior Director of Business Development. He has over 25 years of experience working within and providing services to biopharma and pharmaceutical companies. Prior to joining Curapath, Mark was Director of Global Sales & Marketing at FlowMetric Life Sciences. Previously, Mark worked for 11 years at Thermo Fisher Scientific, where he held several senior, commercial leadership roles, including managing an international sales team and serving as a global relationship manager for Thermo Fisher’s largest bioproduction clients. Additionally, Mark has experience in pre-clinical drug discovery and medical research, having worked at Merck & Co., Nemours/duPont Hospital for Children, and Exelixis. In his role at Curapath, Mark leads the Sales and Business Development team to drive new business opportunities and guides the organization’s strategic initiatives. Mark holds a Bachelor of Science in Biology and a Master of Science degree in Genetics from Purdue University.
Laura is the Quality Director and Qualified Person at Curapath. She is a trained Pharmacist and has a Ph.D. in Medicinal Chemistry. Laura has developed her career in the pharmaceutical industry with more than ten years of experience, first occupying R&D-related roles and progressing to positions specializing in GMP quality environments. Laura has expertise in managing GMP activities in Quality Control and Quality Assurance. She served as a Quality Control Specialist for third-party projects in Esteve Química, where she led projects from clinical stage Drug Substance through FDA marketing authorization. In addition, Laura acted as the Quality Assurance Manager at Laboratorios Edefarm, overseeing the manufacturing of commercial Drug Products. She joined Curapath in 2020, and manages the Quality Systems, and oversees the batch release of material manufactured at Curapath. Additionally, Laura hosts inspections and audits from regulatory Health Authorities and customers. Laura was instrumental in Curapath’s recent accreditation for GMP Investigational Drug Product manufacturing by the Spanish Agency for Medicine and Health Products (AEMPS). AEMPS is the regulatory agency that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Spain and acts as a representative of the European Medicines Agency (EMA).
Angeles is Head of Administration and Finance at Curapath. She has more than 25 years of experience managing financial departments in national and international companies in the technology, automotive, automation and import/export sectors. Angeles’ expertise includes all aspects of Finance and Control, such as reporting, analysis, forecasting, margin calculation, treasury, taxes, and accounting review. She brings strong analytical and teamwork skills to Curapath. Angeles earned a degree in Economics and Business from Universidad de Valencia.
News & Resources
Curapath Receives Accreditation as a GMP Investigational Drug Product Manufacturer from the Spanish Agency for Medicine and Health Products
Valencia, Spain and Boston, MA, January 26, 2023 – Curapath, a leader in the design, development, andcustom manufacturing of polyamino-acid- and lipid nanoparticle (LNP) delivery systems for therapeuticsand vaccines, today announced the company has received accreditation as a GMP investigational drugproduct manufacturer from the Spanish Agency for Medicine and Health Products (AEMPS). AEMPS isthe regulatory agency that oversees the quality, safety, and efficacy of pharmaceuticals and medicaldevices in Spain and acts as a representative of the European Medicines Agency (EMA). “The authorization of manufacturing for clinical drug product from AEMPS is an exciting milestone forour facility in Spain,” said Robert Shaw, Chief Executive Officer of Curapath. “The recognition of ourcapabilities by this regulatory body means that we can produce drug substance and drug product for ourcustomers’ clinical programs. Importantly, it also provides our customers with the confidence to knowCurapath is well positioned to support their future commercial supply requirements.” This approval builds upon Curapath’s industry leading expertise in the custom design, development, andproduction of polymer and lipid-based delivery systems for cell therapy, gene therapy, and vaccines. About Curapath Curapath is a leading GMP-grade manufacturer of polyamino-acid (PAA) and lipid-based nanoparticleencapsulation technology for advanced drug delivery applications including mRNA, DNA, cell therapies,gene
Curapath Announces Collaboration with Afrigen Biologics to Advance Development of African-owned mRNA SARS-CoV-2 Vaccine
Curapath will develop and optimize a process to produce a nanoparticle formulation for the vaccine Valencia, Spain and Boston, MA, November 16, 2022 – Curapath, a leader in the design, development, and custom manufacturing of polyamino-acid- and lipid-based nanoparticle delivery systems for therapeutics and vaccines, today announced a collaboration with Afrigen Biologics to advance the development of the first African-owned mRNA SARS-Cov-2 vaccine. Under the collaboration, Curapath will be responsible for development of a scaled-up manufacturing process of the nanoparticle formulation for the vaccine and will assist in developing the fill/finish process. Afrigen Biologics leads a South African-based mRNA technology transfer hub consortium, supported by the World Health Organization (WHO) and established to address concerns that less affluent countries were not getting sufficient access to vaccines against COVID-19. The goal of the WHO vaccine initiative is to help manufacturers in low- and middle-income countries produce their own Covid-19 vaccines and eventually, produce other vaccines and therapeutics using the mRNA platform, reducing reliance on pharmaceutical companies in high income geographies. The goal is to build capacity in low- and middle-income countries by transferring technology and know-how to a network of recipients (spokes) through a center of excellence and training such as