GMP pharmaceutical manufacturing

Monitor critical parameters of bioprocesses to secure batch release even in challenging conditions

Moving from small scale process development to commercial manufacturing is a challenge. Scale-up brings additional complexity due to a higher level of automation and control. Both quality and process parameters need to be monitored and controlled in real-time to meet product quality specifications, GMP compliance and productivity requirements. We work with you to find the best ways to keep your pharmaceutical production under control.

What you can do

As a pharmaceutical manufacturer, quality standards, FDA regulations and GMP guidelines are your daily business. Monitoring the right process conditions is of utmost importance when it comes to ensuring compliance and securing batch release. Measurement devices play an important part in this process, since the control critical parameters, making sure the cells are growing, and the desired protein is produced.

  • Bioreactor and foam level measurement and control

  • Protein separation in chromatography skids

  • Analytical measurement in both laboratory and manufacturing

  • Field instruments for easy calibration

  • Entire instrumentation designed according to the ASME BPE standard

Learn how to standardize your instrumentation

bioprocess overview ©Endress+Hauser

Bioprocess overview

fermentation process ©Endress+Hauser

Fermentation process

chromatography process ©Endress+Hauser

Chromatography process

virus filtration process ©Endress+Hauser

Virus filtration process

concentration process ©Endress+Hauser

Concentration process

Applications

fermentation process

Keeping conditions in bioreactors under control

Fermentation is a very complex and sensitive bio-process with a high demand on long-term stability and accuracy. Aseptic conditions must be ensured strictly over the whole biopharmaceutical manufacturing process. To fulfill these requirements consistent measurement is necessary:

  • redundant pH and DO measurement

  • temperature control

  • head space and foam level

  • feed flow control

  • pressure control

chromatography

Get the most out of your chromatography skid

Chromatography is used to separate the target protein from the complex mixture of the fermentation broth by different interactions with the immobile phase. pH and conductivity define the conditions of the separation process. The target protein is detected by a UV sensor.

  • pH and conductivity measurement

  • UV process photometer

  • Flow control

  • Overpressure and over-temperature protection

ph measurement

Ensure stable inline pH measurement during fermentation

pH is a critical control parameter in a bioreactor. Each cell line has its own optimum pH range for efficient cell growth and protein expression. From laboratory to large scale manufacturing, consistent and reliable data is required. Using the same digital technology over all scales for the pH loops, provides maximum safety and allows an innovative calibration philosophy in the laboratory.

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Meet our expert

Nobody knows the challenges of the Life Sciences industry better than you. Our experts have years of experience within this industry. They know what good manufacturing practice means and they understand the regulatory requirements. They are specialists in finding the best device to fit your application needs so you can achieve your goals. They are the people for process automation. Meet Klaus Köhler, one of these people.

Klaus Köhler, Global Industry Manager for live sciences industry

Benefícios

Streamline your projects for the biopharmaceutical manufacturing process together with our employees, like Klaus Köhler. They provide both a complete range in instrumentation and profound industry expertise to find the best solution for your needs.

  • 80 %

    reduction of instrument type diversity

  • 2 months

    faster time to market

  • 0

    changes of instruments, thanks to right-first-time specification