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.
Start With
Curapath
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 knowledgable 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
R&D and
Discovery
We apply innovative creative thinking to
solve your drug delivery challenges.
- Polymer And Lipid Custom Synthesis
- (Bio)Conjugation
- Nanoparticle Fast Formulation Screening
- BioAnalytical Assays
Preclinical Development
We establish a robust, scalable process, implement analytical methods, and manufacture non-GMP pilot batches.
- Novel Functional Excipient and Drug Substance Process Development
- Lipid and Polymer Nanoparticle Formulation Development
- Method Development & QC
- Small Scale Lipid Nanoparticle Manufacturing
Clinical
Supply
Progress toward IND filing smoothly; from prototype optimization to GLP tox studies and GMP production of drug substance and product for clinical trials.
- IND/IMPD Enabling Package
- Clinical Trial Material Supply
- Aseptic F&F
- Method Development & QC
Commercial Manufacturing
We offer comprehensive services for commercial scale manufacturing, quality assurance and regulatory processes to bring products to market.
- Clinical Trial Material Supply
- Process Validation and Licensure
- Commercial Supply
- Regulatory & CMC-IND filing support
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
- GPC-MALS-RI
- LC-MS
- HPLC, IC
- GC-FID
- FTIR
- NMR
- DLS
- Rheometer
- Precision Balances
- Equipment for microbiological control
Track Record
150+
80+
10+
100+
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
- Formats:
- 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
Robert Shaw
Robert is the Chief Executive Officer of Curapath. He has more than 30 years of experience leading business, commercial, and technology organizations in the biopharmaceutical service and supply areas. Most recently, he served as Executive Director of the Standards Coordinating Body for Regenerative Medicine. Previously, Robert led the Technical Services Organization and the Cell Culture and Cell Therapy business of Thermo Fisher Scientific as Vice President of the BioProduction Division. He also served as Vice President of Commercial Development at Progenitor Cell Therapy, a leading contract development and manufacturing organization. Prior to this, he led the stem cell initiative at MilliporeSigma as Commercial Director, served as strategic product leader at Wyeth (now Pfizer), and was Assistant Director of Development at Sanofi Pasteur. He received his MBA from Loyola University, Maryland and MS and BS from the University of Toronto.
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.
JON JESSMER
As Vice President of Operations of Curapath, Jon is responsible for establishing cGMP commercial manufacturing in the US including the design, construction, commissioning, and qualification of a new polypeptide manufacturing facility. He also oversees the technology transfer and scale-up of products in the Curapath portfolio to enable the supply of high-quality cGMP-compliant polyamino-based drug substances for customers. Jon has more than 20 years of leadership experience in the biopharmaceutical industry including the development and commercialization of small molecules, biologics, and gene therapies. He also has extensive experience with facility startups, process validation, and internal/external cGMP manufacturing. Before joining Curapath, Jon served as VP of Global Quality at Amicus Therapeutics where he oversaw the company’s clinical and commercial portfolio and was instrumental in the submission and acceptance of the BLA and NDA for AT-GAA for late-onset Pompe disease. Earlier in his career, he held operations, technical and quality roles at Shire, NPS Pharmaceuticals, and Merck Sharp and Dohme. Jon has a BS degree in chemical engineering from Clarkson University.
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.
ANGELES PAREDES
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.
KIM W. NOWELL
Kim is Head of Human Resources at Curapath. Kim works on broad-based HR projects, culture, transformation and change management initiatives. Prior to joining Curapath, Kim served as Executive Vice President of Human Resources and Chief People Officer for Save-A-Lot in St. Louis, Missouri, where she was responsible for talent acquisition, learning and organizational development, human resources business partnerships, and internal communications. Kim has provided effective HR leadership to numerous other organizations, and brings extensive experience in private equity, family owned and publicly traded businesses. Kim earned a Bachelor of Arts degree in Psychology from the University of Tennessee, and a Master of Arts degree in Industrial and Organizational Psychology from Middle Tennessee University.
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
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