Nanotechnology Characterization Lab Collaborators

Recent Collaborators

Peter Bonitatibus, Rensselaer Polytechnic Institute
Our goal is to deliver an urgently-needed CT contrast agent with new capabilities that include improved tumor detection and treatment monitoring. Dr. Bonitatibus developed a prototype tantalum oxide nanoparticle CT contrast agent (TaCZ) that uniquely behaved as a blood-pool agent yet rapidly cleared renally on par with clinical iodinated agents. Enhancement benefits over clinical small-molecule agents at later time points and in large patients (swine) were profound. In preclinical models (rats), TaCZ showed no evidence of renal injury, no acute toxicity at 6x clinical dose, and negligible tissue retention. TaCZ promises to transform X-ray-based medical imaging for many indications. We continue to expand on the preclinical safety profile of TaCZ and validate the agent for CT tumor detection, characterization, and treatment monitoring in preclinical models.

https://science.rpi.edu/chemistry/faculty/peter-j-bonitatibus-jr

January Therapeutics
January Therapeutics is a San Diego-based biotechnology company developing albumin-based targeted medicines for cancer. January’s nanotechnology utilizes specialized understanding of cancer biology, albumin biochemistry and proprietary chemistry to design and develop drug candidates with superior pharmacokinetics and improved therapeutic ratios.

https://januarytx.com/

Testimonials

Yechezkel (Chezy) Barenholz, Hebrew University Hadassah Medical School
“NCL worked on two projects for my lab and one of the start-ups I founded, LipocureRX LTD. In both projects, NCL studies provided invaluable characterization assistance for two liposomal products being developed at Lipocure. NCL provided extensive analysis of the physical and chemical properties of the formulations, including detailed studies on the stability and degradation products of the formulation, in vitro cytotoxicity studies in multiple cell lines, multiple in vitro immunotoxicity studies to build upon our knowledge of the formulation’s safety profile, extensive assistance in endotoxin testing, and in vitro and in vivo pharmacokinetic studies. The expert analysis of these data helped to solidify our regulatory approach for these products, and we are currently in pre-IND discussions with the FDA. Additionally, the reports we received from NCL helped us to get an approval for the first in man study we performed in Israel.“

Matthieu Germain, Nanobiotix
"The NCL cascade assay was very useful to Nanobiotix for the development of one of our intravenously administered nanomedicine products. NCL's collaborative approach, from application through completion, was instrumental to our efforts. NCL adapted their characterization process to fit the needs of our project, tailored smart protocols to answer our questions in a timely manner, and provided meaningful results and suggestions throughout. Given this experience, we highly recommend application to the NCL cascade assay for companies aiming to accelerate product development. "

Andrew Brenner MD, PhD, University of Texas Health Science Center
“The NCL has been pivotal for our group in the clinical translation of Rhenium Nanoliposomes and bringing this technology forward for our patients. As part of the Pre-IND process, the Food and Drug Administration requested validation of our manufacturing techniques and additional drug characterization. This work was undertaken by the NCL, provided as part of the CMC section of our IND, and resulted in a successful IND application. Rhenium Nanoliposomes are now completing phase 1 clinical trial, with phase 2 planned to begin within the year. We are extremely grateful for the expertise provided by the NCL.“

Jun Li, Co-founder and CSO, ZY Therapeutics, Inc.
“ZY Therapeutics’ collaboration with NCL has enabled us to successfully advance ZY-010-PNP from discovery-phase toward a pending IND filing. In addition to the NCL team’s broad expertise in nanotechnology, open and concrete communications between NCL and ZY have proven critical to our progress. The NCL team’s input has helped us resolve several key technical issues, including an effective method to control endotoxin levels in ZY’s polymer which optimized our CMC process to meet standards for injectable formulations. Increased understanding of our formulation’s release kinetics, performed via NCL’s stable isotope tracer ultrafiltration assay (SITUA), solidified our development strategy with this drug candidate. Most importantly, NCL shared with us their passion in finding improved therapy for cancer patients.

ZY technical team’s collaboration with NCL on the development of ZY-010-PNP has significantly reduced our cost and increased the development speed for this promising therapy. Without NCL input, we might still be struggling with many issues associated with natural complexity with nano-formulation.“

Andre Nel, Distinguished Professor of Medicine, UCLA
“NCL provided top quality characterization and evaluation of a nanocarrier intended for chemotherapy delivery in pancreas and colon cancer. The characterization was well planned, executed and we received comprehensive and detailed feedback that was extremely valuable in improving the safety and performance characteristics of our carrier. The NCL scientists indeed showed in-depth understanding of how to evaluate the characteristics and operational features of nano-enabled drug delivery systems, in vitro and in vivo. The interaction with the staff was pleasant and it was a real pleasure collaborating with NCL. NCL clearly constitutes one of the top places in the world to have nanomaterials characterized for therapeutic use”.

Jon Lovell, Associate Professor, University at Buffalo
"Working with the NCL was a valuable and educational experience. Their experienced and professional team characterized our formulation using numerous assays that cover a range of analytical testing parameters, many of which are critical but would not have occurred to me. Overall, the NCL greatly advanced our product development and we have subsequently been able to have a pre-IND meeting with the FDA."

Academic Collaborators

Corporate Collaborators

Government Collaborators

• The FDA’s Center for Biologics Evaluation and Research (FDA CBER)
• The FDA’s Center for Devices and Radiological Health (FDA CDRH)
• The FDA’s Center for Drug Evaluation and Research (FDA CDER)
• The FDA’s Center for Food Safety and Applied Nutrition (FDA CFSAN)
• The FDA’s National Center for Toxicological Research (FDA NCTR)
• The FDA’s Office of Generic Drugs (FDA OGD)
• The NCI’s Center for Cancer Research
• The National Institute of Environmental Health Sciences (NIEHS)
• The United States Army Center for Environmental Health Research (USACEHR)
• The United States Army Medical Research Institute for Infectious Diseases (USAMRIID)