mAb, ADC, recombinant

Two operators in a lab operating a Raman system to monitor upstream bioprocess CPPs and CQAs in-line and in real time.

In-Line Real-Time Monitoring of CHO Cell Culture Process Parameters using Raman Spectroscopy

• 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.

Lab technician uses Raman technology to monitor their process

Integrated Glucose Control in CHO Culture via Raman Spectroscopy

• 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.

Two operators in a lab operating a Raman system and analyzing the data from their bioprocess activities.

Applications and Uses of Raman Spectroscopy in Bioprocessing

• 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.

Two operators in a lab operating a Raman system and analyzing the data from their bioprocess activities.

Unlocking Bioprocessing Insights: Exploring Chemometrics with Raman Spectroscopy

• 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.

On Demand Webinar – Unleashing the Power of Perfusion: Cell Line Development for Intensified Processes

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.

Two operators in a lab operating a Raman system to monitor upstream bioprocess CPPs and CQAs in-line and in real time.

Raman Spectroscopy as an advanced PAT Tool For In-Line and Real-Time Monitoring of Bioprocesses

• 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.

PAT involves the use of different technologies such as chromatography, spectroscopy, or mass spectroscopy to enable real-time monitoring and control of the process.

How to Build Quality into Biopharmaceutical Processes with Real-Time Monitoring and Control

• 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

How Process Monitoring Tunnels Ensure Product Quality and Improve Process Performance

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.

Biopharmaceutical Application Guide

Biopharmaceutical Application Guide helps overcome process challenges

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.

Scientist sitting a desk, in a lab, smiling, using a bioprocessing software to help with 21 CFR part 11 compliance

What to Know About Data Management and 21 CFR Part 11 and EudraLex Annex 11 Compliance

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.

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