Replies to post #115065 on NanoViricides Inc. (NNVC)

[changes_iv]

Dr. Eugene Seymour's letter March 11, 2014:

"We are also scaling up the production process TO KILOGRAM QUANTITIES. The very strong safety of our drug candidate means THAT WE NEED VERY LARGE QUANTITIES FOR THE SAFETY AND TOXICOLOGY EVALUATION STUDY ("TOX PACKAGE")."

In the process to scale-up/produce 1Kg of FluCide(TM)is the 200g production. Did we ship 200g to BASi?

With this information, and in consultation with BASi, we designed the safety/toxicology protocols for certain starting studies. We estimated that the total "Tox Package" studies would need as much as 2.5kg of the drug substance. Recently we broke up the study into parts and developed a starting study protocol that would require a 200g batch. Simultaneously, we have successfully scaled up our synthesis processes in the current Wood Street facilities, to be able to produce a 200g batch. The material we produced has gone through certain tests for its quality. We then prepared the samples as per the protocol design, and we have shipped them to BASi yesterday.

http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20FluCide%20Samples%20Were%20Shipped%20To%20BASi%20For%20Start%20of%20Safety%20Toxicology%20Studies%20Also%20Reports%20That%20Ebola%20Drug%20Candidates%20are%20Being%20Synthesized.html

NanoViricides Inc. PR April 16, 2014:

"The Company also reported that it is producing Injectable FluCide™, our most advanced drug candidate, at its existing facilities, in the large quantity needed for the Safety and Toxicology ("Tox Package") study. The strong safety observed in preliminary safety studies resulted in requirement of a very large quantity for the Tox Package study. Notably, the drug candidate was found to be safe even at the maximum feasible dosage level in a small animal study. The Company reports that it has successfully scaled up the production of injectable FluCide at its current facility."

In the large quantity, that is 200g. Did we ship to BASi to get tox studies started for Phase 1 and Phase 2? Did we scale up production at that time from 100g to 200g? Did we ship to BASi the 200g?

NanoViricides Reports FluCide™ Samples Were Shipped To BASi For Start of Safety/Toxicology Studies; Also Reports That Ebola Drug Candidates are Being Synthesized

http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20FluCide%20Samples%20Were%20Shipped%20To%20BASi%20For%20Start%20of%20Safety%20Toxicology%20Studies%20Also%20Reports%20That%20Ebola%20Drug%20Candidates%20are%20Being%20
Synthesized.html

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About Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study(2014)

Abstract

Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.

FROM THE CLINICAL EDITOR:

Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness.
http://www.ncbi.nlm.nih.gov/pubmed/23969105