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Robust commercial scale bioprocessing workflows must be established along with strategies for sterility assurance during the production of allogeneic products.
Bioprocessing considerations include:
• Establishing a robust process
• Ensuring process compatibility
• Creating the sampling plan
• Planning for media production

Sterility assurance considerations include:
• Using GMP materials
• Qualifying raw materials
• Adopting closed processing
• Performing aseptic process simulations
• Ensuring proper sterile filtration
• Understanding extractables, leachables, and particulates

• Traditional cell culture monitoring offers limited insights, while real-time measurement of critical process parameters provides direct indications of culture state.
• Implementing process analytical technology (PAT) for in-line, real-time measurements improves process understanding, decreases risk, and enables more advanced process control.

• Integration of Raman spectroscopy with an automated feedback loop revolutionizes biopharmaceutical manufacturing, enabling real-time glucose level monitoring and precise maintenance for optimal process quality and glycosylation.
• This innovative approach eliminates manual sampling, reduces contamination risks, and ensures reliable, real-time process control, empowering users to navigate upstream biopharmaceutical manufacturing with confidence.

• Raman spectroscopy enables inline and real-time assessment of crucial process parameters and critical quality attributes during process development and manufacturing.
• It employs a chemometric approach to identify, quantify, and measure the concentration of key compounds in complex liquid media during upstream (USP) or downstream (DSP) processes.

• Chemometrics is an interdisciplinary field that uses mathematical, statistical, and computer methods to extract valuable information from analytical data.
• When combined with Raman spectroscopy, chemometrics allows for the analysis of relevant data, enabling the generation of detailed insights on bioprocess activities and the development of more efficient models.

The AAV vector manufacturing process involves cell lysis and nuclease treatment. Advanced techniques, such as using high salt concentration and a salt-tolerant endonuclease, can enhance vector titer and infectivity. Additionally, the development of a non-animal origin, salt-tolerant Benzonase® endonuclease has shown significant impact on AAV5 capsid titers and AAV2 vector infectivity.