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FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

“For each production process, you have to generate the plasmids in huge quantities with GMP quality and then do a transient transfection, meaning you mix them with a transfection reagent and add that to the cells in a very controlled way,” explains Faust. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. 1] BioNews.

Genome 244
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Biopharma Update on the Novel Coronavirus: October 20

The Pharma Data

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. It allows the test to be used for people without any symptoms or suspicion of COVID-19, supporting widespread population testing. Please read more here. .