01.08.24 -- Designing Facility Monitoring Systems For Cleanrooms

Successfully maintaining critical process parameters (CPPs) for bioreactors helps to optimize product quality, potency, impurity profiles, total cell density, and titer/protein concentration (productivity).

Discover the statistical analysis results based on several DoE studies for the reduction of hcDNA and pDNA levels in a lentiviral vector platform process.

Uncover how allogeneic therapies leverage donor cells to ensure optimal starting material for patients to receive treatment without delays, ultimately improving safety and expanding patient access.

Learn why change control must be applied to every aspect of good manufacturing practices to guarantee that a facility and the products it produces are compliant with regulatory standards.

Explore some of the common challenges encountered when sourcing plasmid DNA and recommendations for navigating common pitfalls to future-proof your plasmid supply.

Consider the obstacles patients encounter when seeking CGTs and how technology and patient services can empower manufacturers and clinical teams to help.

Review a scalable suspension-based lenti production platform using a proprietary HEK293T clonal cell line and improvement steps to generate commercially viable therapies from concept to patient.