NanoViricides Inc. (NNVC)

[changes_iv]

NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.
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We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html

And if the nanoviricides(R) are bioequivalent, once you get the scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they?
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About Microfluidics and Nanofluidics...


Scaleup with Repeatable Results

Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
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Of course, achieving success in the lab is only valuable it can be repeated reliably, regardless of scale. Microfluidics further differentiates from other technologies in that not only are results repeatable from batch to batch, but also from lab environments to pilot and production volumes. This is achieved by aligning microchannels in parallel within the interaction chamber, with a a single output reservoir. This essentially ensures the entire product stream experiences identical shear, resulting in consistent quality no matter the volume, from 1 mL (with the new LV1 low volume machine) up to 60 liters-per-minute.
http://www.microfluidicscorp.com/our-technology/how-it-works

New Alliance Between Microfluidics And Particle Sciences Expands Reach Of Microfluidizer® Technology

Microfluidics and Particle Sciences collaborate to extend the application, expertise and support of unique high shear fluid processors.

[4/06/2015] — Westwood, MA — Microfluidics, exclusive global creator of Microfluidizer® high shear fluid processors, is now partnering with Particle Sciences, Inc., a leading contract development and manufacturing organization (CDMO). This new alliance is designed to give the companies more ways to serve their clients with complex formulation development as well as lab support testing services in Pharmaceutical and Biopharmaceutical processing.

“Particle Sciences has been a good partner in the past, making our decision to work more closely with them an easy one,” said Brad Besse, Business Unit Director at Microfluidics. “They have shown themselves to be leaders in nanoparticle production, specifically with our technology.”
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CEO at Particle Sciences, Dr. Mark Mitchnick, added, “Particle Sciences is the leading CDMO for nano-based products. We have worked with Microfluidics since before their acquisition by IDEX, and already have several machines installed. We are seeing an increasing need for the highly consistent performance Microfluidizer® technology is able to deliver. This, combined with Particle Sciences’ deep understanding of the technology and our base capabilities in characterization and sterile production is driving the relationship expansion. We have formulated multiple products with Microfluidizer® technology, recently manufacturing 120L of a sterile emulsion for a client using the equipment and have several more in the pipeline.”

Besse also said he believes “that by working together, both parties can expand their application expertise and support services to better serve our customer needs. In addition to formulation and clinical trial production, Particle Sciences affords our customers the ability to work with highly potent compounds under cGMP guidelines, in a purpose-built facility.”
http://www.microfluidicscorp.com/latest-news-a-events/200-new-alliance-between-microfluidics-and-particle-sciences-expands-reach-of-microfluidizerr-technology

Micro & Nano Technology

Particle Sciences has been at the forefront of drug delivery related fine-particle and nanotechnology formulation since the early 1990s. We provide a wide range of particulate fabrication and drug product preparation services. Our efforts have resulted in commercial products including nanoparticles scaled to as much as half a million kilos per year. Whether it's Particle Sciences' proprietary technology or conventional systems, our staff knows how to apply these tools to meet your needs.

The incorporation of an API into a particle can take many forms. Possibilities range from an emulsion droplet to any number of encapsulation systems to a Lyocell® to a nanoparticle of the API itself. These various formats cover a range of sizes from tens of microns down to several nanometers, each providing their own utility with respect to any given API. Reasons for using a nanoparticle or larger particulate can include:

Incorporation of difficult to solubilize APIs
Controlling bioavailability
Controlling drug/excipient interaction
Improving API stability
Targeted delivery
Controlling uniformity
Taste masking
Altering pharmacokinetic and toxicological profiles
Intellectual property
Lifecycle management

Having a full range of technologies and the needed equipment provides us with options assuring that the best solution for our client is achieved. Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano capsules.



Our micro/nanoparticle fabrication labs are supported by in-house cGMP/cGLP analytic facilities and ICH stability testing programs. We can seamlessly bring your product into the clinic, producing clinical trial materials and commercial supplies. We have worked with small molecules, oligonucleotides, peptides, proteins and carbohydrates. We are FDA registered and DEA licensed for all scheduled substances.
http://www.particlesciences.com/services/micro-nano-technology/