mAb, ADC, recombinant

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.

Mirrored disco balls

Bridging the Sponsor – CMO Data Gulf

Single-source manufacture of biopharmaceuticals is becoming more and more rare. Increasingly, biomanufacturers or “sponsor” companies partner with contract…

Strengthening the CDMO-Sponsor Partnership with Improved Data Sharing and Collaboration

Collaboration between biomanufacturers and CDMOs often experiences challenges with data sharing. This presentation highlights the management of heterogenous and asynchronous data and how a data integration platform can improve project lifecycle data management, and collaborative data sharing.

Bioprocessing operators in a closed processing CNC space

Are you OPEN to CLOSE your bioprocess?

In this webinar, you will:
•Understand the main drivers and benefits of closed processing in biopharma, including facility utilization, sustainability, cost reductions, and labor savings.
•Analyze biopharma facility design, comparing traditional layouts to innovative, modular, and ballroom-style configurations.
•Learn about industry guidance and best practices in the adoption of closed processing.

What if you could enable upstream intensification of your process?

In this webinar, you will learn how our new single-use bioreactor family can help you:
– Fulfill any process strategy, be it batch, fed-batch or perfusion
– Facilitate scalability of your upstream process
– Utilize the flexible design to reduce production costs

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