Newsletter | September 26, 2023

09.26.23 -- Mechanistic Modeling To Optimize rAAV Production For Gene Therapy

FEATURED EDITORIAL

Mechanistic Modeling To Optimize rAAV Production For Gene Therapy

Current processes in recombinant adeno-associated virus (rAAV)-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and you can use it to test a wide range of conditions and hypotheses.

CGMP Requirements For Automated Facility Monitoring Systems

To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

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