IIVS has a long-standing history of working with various industries to help establish or utilize in vitro models for the prediction of risk and the assessment of products under development. With the Food and Drug Administration extending its authority to all tobacco products (including e-cigarettes, cigars, and hookah) the tobacco industry is faced with the task of assessing product safety for product development and regulatory submission. Further, the manufacture of tobacco products may entail risk to workers that come in frequent contact with the materials being processed. In order to create safer products the potential risk needs to be understood and this requires testing these materials using biological systems.
As a proponent of new technologies and assays that can better assess tobacco product safety, IIVS has established a Workshop series geared toward information exchange and the education of researchers so that in vitro research for tobacco product evaluation technology is accelerated and improved.
Tobacco product exposure can occur in a variety of ways and includes dermal, ocular, buccal, and respiratory routes. IIVS has expertise using numerous in vitro systems that model tissues along the various routes of exposure. While cell lines and 2-dimensional cell cultures may be well-suited for the screening of many products or materials, more complex 3-dimensional models such as human reconstructed airway tissue or precision cult lung slices offer multiple cell types and functionalities that more accurately reflect events occurring in the whole organ. The portfolio of biological models and assays used to evaluate cell and tissue responses to tobacco product exposures will provide insight that can guide product development and help evaluate potential risk.
Let IIVS advise you and be your partner in testing!
- Familiar with regulatory guidelines and fully GLP-compliant, IIVS can help you establish screening paradigms to suit your needs and help you attrition your product candidates so that you bring the best ones to market.
- Interested in prolonged exposures or delayed effects after exposure? Let IIVS develop a testing strategy that can elucidate key events such as goblet cell hyperplasia, altered ciliary beat frequency, or chronic tissue inflammation.
- Do you have products that are consumed orally? Let IIVS test product permeability through buccal tissue or evaluate the potential for cytotoxicity.
- Interested in establishing GLP-compliance in your lab? Let IIVS’ Quality Assurance department consult you on how best to create that environment.
We also specialize in assay standardization and validation so that in vitro and ex vivo assay systems gain the acceptance they deserve!