NCL News Archive

Friday, June 29, 2018

NANOBIOTIX Announces Positive Phase II/III Results with NBTXR3

Nanobiotix, a former NCL collaborator and Assay Cascade awardee, recently announced positive results from a phase 2/3 study of NBTXR3 in soft tissue sarcoma. NBTXR3 (hafnium oxide nanoparticles) combined with radiotherapy showed a better response than radiotherapy alone in a trial of 180 patients. From the Nanobiotix website:

Trial achieved its primary endpoint of pathological Complete... View Post


Thursday, June 28, 2018

AAPS Forum on FDA Guidances

A Guidance Forum Workshop, presented by AAPS, will take place September 11-12, 2018, in Silver Spring, MD. The focus of the workshop will be to discuss challenges, issues and concerns for the FDA guidance documents that are most important to AAPS members. From a poll of stakeholders, two guidance documents have been selected for this forum:

Drug products... View Post


Monday, June 4, 2018

FDA Guidance on Liposome Drug Products

The FDA recently finalized a guidance for industry document on liposome drug products. The guidance focuses on the chemistry, manufacturing and controls; human pharmacokinetics and bioavailability; and labeling documentation.

The guidance document can be downloaded from the FDA’s website here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/... View Post


Monday, June 4, 2018

Nanoparticle Inhibits Growth of Pancreatic Cancer in Mice

A novel polyplex nanoparticle formulated at the NCL is shown to inhibit growth of pancreatic cancer and prevent metastasis in mice. The study was co-lead by Dr. Jill Smith of Georgetown University and Lombardi Comprehensive Cancer Center and NCL’s Pharmacology and Toxicology Section Head Dr. Stephan Stern. The results of the study were recently published in Cellular and Molecular... View Post


Monday, May 7, 2018

May 2018 Awardees Announced

Each quarter the NCL accepts the most promising cancer nanomedicine candidates into its Assay Cascade characterization and testing program. Nanomedicines accepted into the program will undergo a rigorous evaluation that may include sterility and endotoxin testing, physicochemical characterization, in vitro hemato- and immunotoxicity, and in vivo studies to evaluate safety, efficacy and... View Post


Friday, April 6, 2018

Opening for a Formulation Scientist

The Nanotechnology Characterization Lab (NCL) provides nanotechnology formulation and characterization services for universities, the pharmaceutical industry and other government programs. Since our founding in 2004, the NCL has characterized more than 400 different nanomedicines for more than 100 organizations worldwide. We are currently seeking a Formulation Scientist to... View Post


Monday, March 12, 2018

Evaluation of Nanomedicine Drug Release and Pharmacokinetics

The NCL has just launched two new Technical Services to measure drug release from nanomedicines—ideal for assessing bioequivalence of complex drugs. These assays are available as a service to nanomedicine developers, apart from NCL’s Assay Cascade application process.

The two assays utilize the Stable Isotope Tracer Ultrafiltration Assay (SITUA), and include:

In vitro drug release... View Post


Friday, December 22, 2017

FDA Draft Guidance, "Drug Products, Including Biological Products, that Contain Nanomaterials" open for comment

The FDA recently published a draft guidance document for “Drug Products, Including Biological Products, that Contain Nanomaterials.” The draft guidance document can be downloaded here: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm588857.pdf

The FDA is requesting public comments on the draft guidance. They are also seeking comment on the... View Post


Friday, November 17, 2017

November 2017 Awardees Announced

Each quarter the NCL accepts the most promising cancer nanomedicine candidates into its Assay Cascade characterization and testing program. Nanomedicines accepted into the program will undergo a rigorous evaluation that may include sterility and endotoxin testing, physicochemical characterization, in vitro hemato- and immunotoxicity, and in vivo studies to evaluate safety, efficacy and... View Post


Wednesday, November 1, 2017

Characterization of Nanoparticles Intended for Drug Delivery

The NCL has recently published a follow-on book to its Characterization of nanoparticles intended for drug delivery. This second edition book, now available for download or purchase, offers new and updated protocols for sterility and endotoxin testing, surface coating quantitation, ICP-MS of biological matrices, in vitro hematotoxicity and immunotoxicity, as well as in vitro methods for... View Post


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