By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, BioTechLogic The elegant simplicity of monoclonal antibodies (mAbs)...
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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...
Gene Therapy for Rare Disorders Becoming Viable
Resurgent across the biomedical engineering and clinical trial landscape, gene therapy owes its new vitality to a better understanding of rare diseases, the discovery...
Six Fascinating Life Sciences AI Applications
Where is life sciences AI heading? More is better when it comes to Big Data and machine learning. This is particularly true in the fields of medicine and pharma. A...
Process Validation & Regulatory Strategies for Fast-track and Breakthrough Therapies
BioTechLogic’s Tracy TreDenick delivered a very well-received presentation at BPI West 2018 discussing process validation and regulatory strategies for expedited approval...
Why Data Integrity Is More Important Than Ever
By Ashley Ruth, Senior Consultant, Analytical Services, BioTechLogic The pharmaceutical and biopharmaceutical industries must give immediate and strategic consideration to...
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