Editorial Perspectives on Downstream Bioprocessing
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4 Keys To Winning FDA Breakthrough Therapy Designation
9/14/2021
Agency filings require accuracy, dialog, order, and precision. We caught up with two biopharma regulatory experts who have seen breakthrough therapy designation success to get their firsthand advice on how to get it done.
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The Placental Stem Cell Advantage
5/11/2021
As Celularity makes its most significant clinical progress to date, the company is putting theories born of 20 years of postpartum placental stem cell research into practice. Could the production platform it’s building be the key to accessible, affordable allogeneic cell therapy?
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Can Single-Use Technology Be Used In Protein Purification?
11/25/2015
Not all areas of the drug development process have been able to be transferred to a single-use platform. One of these areas is protein purification. I recently spoke with Iwan Roberts, chief operating officer and co-founder of Puridify, a company developing bioprocessing technologies for biomolecule manufacturing, about this challenge in the industry and what can be done to overcome it.