Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Watch this webinar to learn how to troubleshoot these and manufacturing deviations that impact viral safety.
Biotechs with less than $1B in total sales represent a significant share of new molecular entity market approvals and launches, growing from 10% in 2017 to 30% in 2021. Small and midsize biotech valuations are thus rising, making them less attractive for acquisition and forcing them to launch on their own. These five launch strategies can bolster the odds of success.
SparingVision CEO Stephane Boissel took the reins of a fledgling, single-asset gene therapy company born of academic research and quickly built a well-funded startup with a deepening pipeline of ocular disease candidates. He told Business of Biotech how it happened.
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By Dr. Kashif Ghaffar,Pfizer CentreOne
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
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By Martyn Ryder, SOLO Containment, an ILC Dover LP Company
Flexible film isolation has been used in aseptic processing since the 1970s, but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface.
4D pharma's flagship early-stage clinical candidates are live biotherapeutics, a relatively new class of biologics that seek to impact disease states by modulating the microbiome. CEO Duncan Peyton is leading the effort to understand how the health of the microbiome relates to a wide range of diseases, including immuno-oncology, CNS disorders, respiratory disease, autoimmune indications, and gastrointestinal disease. Learn more about this new frontier of therapeutic exploration on this Business of Biotech podcast.