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.

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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.

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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.

Preclinical Development

We establish a robust, scalable process, implement analytical methods, and manufacture non-GMP pilot batches.

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.

Commercial Manufacturing

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

mRNA, siRNA, miRNA, saRNA, RepRNA
pDNA, dsDNA
SMALL MOLECULE
PEPTIDE
VIRUS
ANTIBODY & PROTEIN

We Develop Delivery Systems for Your Therapeutic Payload

mRNA, siRNA, miRNA, saRNA, RepRNA
pDNA, dsDNA
SMALL MOLECULE
PEPTIDE
VIRUS
ANTIBODY & PROTEIN

We Provide Precision, Scalability and Flexibility From Start to finish

Payload
DELIVERY TECHNOLOGY
lipid nanoparticle
Polymeric Non-Viral
Hydrogel
Polymer Conjugate
Polymer Drug
Small Molecule
Biologic
Nucleic AciD (RNA, DNA, CRISPR)
Cells

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+

Non-Compendial Analytical Methods Developed

80+

Analytical Methods Validation (ICH Q2)

10+

Formal ICH Stability Programs

100+

Compliant Batches & Customer Audit Compliance

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

In parallel with development of the polymer best suited for your application, we establish phase-appropriate and validated analytical methods that will be implemented 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).

Meet Our Team

Robert Shaw
Chief Executive Officer

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.
Chief Technology Officer

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
Vice President of Operations

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
Senior Director of Business

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
Head of Administration

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
Head of Human Resources

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 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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Polypeptide Therapeutics Solutions (PTS) Announces Company Name Change to Curapath and Expansion of Drug Delivery Capabilities and Services

Expanded capabilities support development and production of novel functional lipid excipients and nanoparticle formulation Addition of late stage clinical and commercial-scale production is also planned Company to present on shielding lipid novel excipients for lipid nanoparticle (LNP) formulations at Lipid Nanoparticles Development Summit on October 20th Valencia, Spain and Boston, MA, October 17, 2022 – Polypeptide Therapeutic Solutions (PTS), a leader in the design, development, and custom manufacturing of polyamino-acid based delivery systems for vaccines and therapeutics, today announced the company has changed its name to Curapath. As part of Curapath’s transformation, the company has expanded existing capabilities in development and production of novel functional lipid and polymer excipients and nanoparticle formulations. “PTS was established ten years ago and since that time, our capabilities and services have continuously expanded to address the evolving drug delivery challenges of our clients, including the world’s leading vaccine and therapeutic manufacturers,” said Robert Shaw, Chief Executive Officer. “Our new name, Curapath, reflects our broadened portfolio of services beyond polymers and represents our commitment to provide support throughout the journey of novel vaccines and therapeutics, from development to approval.” The expanded capabilities build upon the company’s comprehensive portfolio of services which include development, formulation, analytical

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