More consistent and reliable production cell therapy and gene therapy processes are critical for advancing innovative treatments. While cell...
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Articles
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,...
The FDA’s Groundbreaking Strides Toward a Quality-Centric Regulatory System
Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon launching Pharmaceutical cGMPs for the 21st Century –...
Live from the PDA Annual Meeting: Risk Management in Combination Products and Co-Packaged Kits
From post-aging performance testing to container closure integrity, robust design controls extend far beyond “constituent part” requirements. With the increase in complexity...
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...
4 Steps for Managing Biopharmaceutical Projects
Note: BioTechLogic is proud to be featured in the December 2016 issue of Pharmaceutical Manufacturing magazine. The global biopharmaceutical market is expected to grow at a...
