• 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.
In this webinar, you will learn about:
• Optimizing the CLD process for stable, high-performing perfusion clones.
• Incorporating perfusion scale-down models into your CLD workflow.
• Using Mobius® Breez for final clone selection and cost-effective perfusion process development.
• Importance of using the right media for cell line expansion and production during CLD.
• Raman spectroscopy enables non-destructive analysis of chemical composition and molecular structure.
• It provides real-time and in-situ measurements, allowing for sample preservation.
• Raman spectroscopy captures diverse biological and chemical information within a single spectrum and enables identification of specific molecules based on their distinct spectral signatures.
• Implementation of PAT into your bioprocesses ensures quality in biopharmaceutical manufacturing through real-time monitoring and control
• Analytical methods of monitoring and control of identified critical process parameters and critical quality attributes allows PAT to ensure quality of bioprocesses
With a process monitoring tunnel you can monitor 100s of CPPs in a single graphical interface that captures the overall health – both past and present – of your bioprocess and reliably predicts its future health.
Take a few minutes and navigate through our mAb, ADC, mRNA, Vaccine, and Cell and Gene Therapy process templates. Go ahead and dive into each unit operation to uncover the best option for your process.
21 CFR Part 11 and Annex 11’s purpose is to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offer benefits like access control, audit trails, data integrity, and easy search and retrieval of information.
