Opened in October 2016, the Nitric Oxide Center of Excellence is Novan's engine for the platform technology. Given the unique nature of the Nitricil technology, a resolute focus on quality and process development is essential to Novan’s success.  The Center of Excellence consists of specialized expertise, systems and in-house capabilities designed specifically for developing and manufacturing nitric oxide-releasing new chemical entities. The facility includes class 100,000 manufacturing suites and the ability to manufacture active pharmaceutical ingredients (APIs) and finished dosage forms in accordance with current good manufacturing practices. The Company’s capabilities span from the synthesis of research and development materials and production of clinical trial supplies, to the commercial manufacture of API.

Can the drug substance deliver enough nitric oxide to be therapeutically meaningful?

Nitric_Oxide_Formulation_FAQ_2___thumb.png

Yes. The Novan technology can store and release more nitric oxide than any other pharmaceutically acceptable nitric oxide delivery system. This ability to store orders of magnitude more nitric oxide creates a reservoir that can provide unprecedented high levels of nitric oxide flux (Cmax) or sustainable concentrations over a longer period of time (AUC).  Novan has also discovered that, in addition to its superior storage capacity compared to other technologies, our method of storing nitric oxide can make its delivery more efficacious in pharmacology models.

Can the nitric oxide release be reliably measured for the drug substance? The drug product?

FAQ_Diagrams-Thumb-02.png

Yes. Novan has developed extensive expertise in the analytical techniques for measuring nitric oxide release, both in vitro and in vivo. Novan has established several sophisticated analytical methods specific to nitric oxide. Our facilities include the instrumentation necessary for conducting raw materials release, in-process testing, and the generation of certificates of analyses that reflect not only the dose of the drug product but also the potency of the nitric oxide in both the drug substance and the drug product.

Does the technology have the ability to tailor the physico-chemical properties to manipulate
PK/PD?

FAQ_Diagram-Thumb.png

Yes. Novan is able to tailor the physico-chemical properties of the drug substances and drug products to manipulate the PK/PD of the administered dosage form.   The ability to load nitric oxide onto different macromolecular backbones allows for versatility in molecular weight, solubility, and lipophilicity of the resulting drug substance.  The Nitricil technology also allows for the selection of the size and shape of the nitric oxide-releasing molecule to fit a particular therapeutic application.  Furthermore, the final formulation of the drug product offers an additional level of control over the ability to manipulate nitric oxide delivery to achieve the target PK/PD in vivo.  As Novan evolves, we continue to strengthen our translational knowledge correlating in vitro/in vivo pharmacological responses to enhance the probability for clinical success.

 

Watch Novan formally open the Nitric Oxide Center of Excellence

Novan Center of Excellence Video
Close
Close