We offer our partners a full spectrum of development capabilities, from early stage formulation development to the management of clinical trials and regulatory filings, as well as the manufacturing of clinical and commercial product. Specific to these capabilities is the in-depth experience with the complexities of developing and meeting the requirements for the ultimate approval of nasal formulations. This range of capabilities and our core knowledge in nasal formulations enables us to meet the specific needs of our partners.

Research & Development

Our Research & Development programs offer partners access to advanced programs that are increasing the basic understanding of tight junction biology and developing methods for the delivery of RNAi, as a potential therapeutic. Our discovery and development platforms utilize various screening techniques including high-throughput tissue culture, cell permeation and functional assays, quantitative microscopy and gene expression analysis. In addition, our chemistry expertise enables us to rapidly synthesize and optimize compounds resulting in a library of proprietary compounds to enhance drug delivery.

Formulation Development

We identify the optimal molecule-specific formulation by employing a high throughput screening process that assesses a variety of factors including bioavailability, pharmacokinetics, and cellular toxicity. We have a breadth of experience working with a range of molecules including small molecules, peptides and complex proteins. The power of our process is evidenced by final formulations whose in vitro characteristics consistently correlate with the corresponding attributes in human subjects. For more information see Formulation Science.

Clinical and Regulatory

Our experience in complex clinical trials and regulatory filings is critical to accelerate the development following the initial formulation stage. Our clinical team will work with the partner and the regulatory authorities to design trials that capture the information necessary for product development and regulatory filings. We have extensive preclinical experience with an in-depth understanding of specific FDA requirements related to CMC and pharmaceutical and toxicology characterization of nasal products. Additionally, we have an existing network of US and European sites and have designed clinical programs across numerous medical disciplines. Our regulatory team has experience filing INDs, NDAs and ANDAs, and the specific knowledge necessary to successfully meet the requirements for nasal product approval.

Manufacturing

As the project moves through clinical trials to commercialization Nastech can provide state-of-the-art manufacturing that is fully compliant with cGLP and cGMP as defined by the FDA and the ICH guidelines. We work with partners to provide analytical methods, development and validation, process development, control and scale up in support of a robust CMC (Chemistry, Manufacturing and Controls) section for regulatory filing. Nastech also has DEA registration for research of Schedule II controlled substances. Our expertise and facilities provide partners with the confidence that Nastech manufacturing will support the commercial requirements of their molecules.