J.A. Shatkin, K.J. Ong, J.D. Ede
Vireo Advisors, LLC,
Keywords: nanotechnology, advanced manufacturing, climate technologies, biobased, biomanufacturing, commercialization
Summary:Vireo has been working with nano/bio and advanced manufacturing climate-tech entrepreneurs for the past decade to address market and regulatory requirements for diverse materials and products. These technology-enabled climate solutions have the potential to significantly reduce greenhouse gas (GHG) emissions and provide related pollution prevention benefits. Organizations pursuing commercialization of these next generation materials must determine how to test their safety, as well as demonstrate compliance with a host of customer and end user certifications or acceptance criteria. This is can be quite challenging, as the ‘typical’ standard safety tests regulatory authorities require for substances and food ingredients often require adaptation or new methods for novel materials, that are not yet standardized. Further, there is a need to update methods to meet 21st Century requirements, including approaches that reduce, refine or replace conventional animal testing with alternative testing strategies. A common challenge in assessing the safety of these innovative nanoscale and biobased substances relates to novel approaches and technologies for their manufacture. Regulators can require information about safety – in the workplace, in products and in the environment. Collaboration, including with academic and governmental experts, is critical as pre-commercial work is often required to advance new method development. This presentation discusses some of the challenges in evaluating the safety of nano/bio-enabled climate technologies and opportunities for collaboration that: reduces the costs of developing modified methods and data sets; reduces the overall amount of testing needed; and accelerates the pace of innovation.