While incidents of biotherapeutic viral contamination have occurred, due to well-established knowledge of the potential sources of...
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Gene Therapies
Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the Pandemic
Jeanette Young, senior consultant for analytical services at BioTechLogic talks with Tonia Becker, Life Sciences Editor, Macon Raine As it became clear that the COVID-19...
Lessons from the Pandemic and Addressing Gene Therapy Process Development Challenges
It’s a fascinating time to be in the biotherapeutics industry. What will the remarkedly rapid COVID-19 vaccine development effort teach us about how to develop and scale...
FDA Seeking to Enhance Manufacturing of Cell Therapy and Gene Therapy Products
More consistent and reliable production cell therapy and gene therapy processes are critical for advancing innovative treatments. While cell therapy and gene therapy...
Comprehensive Regenerative Medicine Policy Framework Announced by FDA
On November 16, 2017 the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products,...
Therapeutic Gene Editing: An American Society of Gene & Cell Therapy White Paper
Interested in learning more about gene editing and its therapeutic applications? Download a new white paper from the American Society of Gene & Cell Therapy (ASGCT). The...
