Lexology March 13, 2024
Recent news reports have described the successful progress of at least one company, Varda Space Industries, in developing a space-based drug manufacturing platform and process. The FDA-related regulatory and legal questions and implications of this are intriguing. For example:
- Will FDA need to recruit astronauts to inspect space-based manufacturing facilities?
- What are the intellectual property opportunities and risks for space-made drugs?
- Would a generic or biosimilar version of a space-made drug also be required to be manufactured in space?
By way of background, Varda’s space-based drug manufacturing approach leverages the well-known phenomenon that crystals can be grown in much purer form and in a much more consistent fashion in micro-gravity environments. Indeed, NASA and pharmaceutical companies has been...
Today's Sponsors
Today's Sponsor