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Biopharmaceutical manufacturing - further improve existing processes

Continuously improve platform quality and squeeze more value from current bioprocesses while minimizing risk

Raman Rxn4 analyzer with enclosure and Rxn-45 probe in a stainless-steel bioreactor
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Scientist with bioreactor during the fermentation process of cell cultures for the Life Sciences @Lonza
Introduction

The quest for continuous process improvement in the biopharma industry

Congratulations! You successfully developed a new target molecule and brought it to market. Now what? Almost immediately after introducing a new commercial product, the focus shifts to how the developed process can be optimized to increase efficiency, reduce costs, and maximize yield without compromising supply quality.

Embracing innovation and process improvement is essential for staying competitive and achieving better outcomes in the long run. However, once established processes and methods are in place, any changes can be daunting due to associated risks and compliance challenges. So, where do you begin?

Representative Biopharma 4.0 technology image ©iStock
Biopharma 4.0

Elevate your processes with Biopharma 4.0 innovative technologies

Biopharma 4.0 offers significant potential for enhancing biopharmaceutical manufacturing procedures, elevating product standards, and cutting down expenses. Supported by QbD and PAT frameworks, Biopharma 4.0 integrates the principles of Industry 4.0 digital transformation into the biopharmaceutical manufacturing industry. It aims to establish automated smart factories equipped with real-time surveillance and process control. Implementing Biopharma 4.0 tools like Raman spectroscopy and digital Memosens technology allows for early identification of process discrepancies and predictive maintenance.

Endress+Hauser measurement technologies can be applied to monitor regulatory-approved bioprocesses with no impact to compliance, as long as they are not used as primary process or quality control tools (unless the filing is updated accordingly). This reduces the likelihood of batch failures while ensuring consistent product quality and yield. Strengthening existing processes with new technologies is strongly encouraged by regulatory bodies, benefiting both manufacturers and patients.

eBook thumbnail image of Endress+Hauser's Life Science inline measurement bioprocessing portfolio ©Endress+Hauser
Our portfolio

Get to know our full analytic portfolio for bioprocessing

Endress+Hauser offers a complete suite of bioprocessing measurement instrumentation - including world-class Raman systems (spectrometers, probes, optics, and accessories powered by Kaiser Raman technology) and liquid analysis digital analysis systems (photometers, transmitters, Memosens sensors, Memobase software, and assemblies). These offerings are complemented by calibration devices, solutions, and modelling services with support from Endress+Hauser's vast global service and support network.

Download our eBook to learn how our field-proven inline measurement tools can help optimize your bioprocesses.

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Raman Rxn-45 probe and Memosens sensors installed in a Life Science bioreactor ©Endress+Hauser
Process transparency

Illuminate the path ahead

Make data-driven decisions based on full process transparency.

Unlocking process improvement opportunities begins with vigilant monitoring and precise control of critical measurement parameters in both your upstream and downstream applications. 24/7 inline process measurement provides valuable insights into bioreactor performance, unveiling a deeper understanding of fundamental process behaviors and cellular functioning. Armed with this level of process transparency, you can fine-tune tolerances and make other data-driven decisions to optimize process conditions and efficiency. Endress+Hauser's comprehensive inline measurement systems – including Raman systems and liquid analysis digital sensors – are ideal tools to implement in your Biopharma 4.0 process improvement program toolset.

Success stories

Real-world customer examples

Check out our upstream and downstream case stories.

Scientists with bioreactors ©Endress+Hauser

Upstream case study - find out how Nicro achieved real-time control of fermentation processes

Learn how Nicro moved from time-consuming sample analysis to real-time monitoring of critical parameters in fermentation processes. The result? Inline process monitoring of metabolites without the need of offline sampling helped improve process control for optimized production and increased yield.

Alvotech scientists with Raman flow assembly ©Endress+Hauser

Downstream case study - get a sneak peek how Alvotech is gaining valuable UF/DF process insights

Find out how Alvotech is enhancing its downstream processing for biosimilar production by enabling real-time monitoring of the protein purification process during UF/DF. The result? The company can realize cost savings, faster processing, and more proactive decision making for increased efficiency.

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Product highlights

Select products for real-time chemical composition measurement

Having pioneered bioprocess Raman with our Kaiser Raman technology, Endress+Hauser has the largest installed base of Raman units in the field and the most customer application successes. Our comprehensive Raman systems – comprised of powerful Raman spectrometers, sampling probes, and optic accessories— are perfectly designed to meet the stringent demands of bioprocessing applications. These innovations have set the bar high for reliable real-time chemical composition analysis of upstream and downstream bioprocesses from lab to process and from batch to continuous operations. Here are just a few highlighted Raman offerings to jumpstart your process improvement efforts.

Select products for measuring your analytical process parameters

For precise and consistent measured values of key process parameters – such as pH, cell growth, conductivity, dissolved oxygen and more – Endress+Hauser offers a range of photometers, transmitters, digital sensors, and assemblies purposely designed with scalability in mind for use in lab, pilot, and process. Our devices feature Heartbeat Technology with built-in predictive maintenance capabilities. Here are just a few highlighted products to explore.

Contact us

Discuss your process improvement challenges with our Life Sciences experts

Have questions about how inline measurement technologies can help improve your upstream or downstream bioprocesses? Let Endress+Hauser be your guide.

Endnotes

More information to consider