PAT Lösungen - Online-Analytik zur Prozessführung

Fermentationsprozesse verstehen

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| Produktdatenblatt BaychroMAT® bioplatform

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: Overview of the BaychroMAT® bioplatform

BaychroMAT® – online analytics for fermentations in process development, pilot plants and production

BaychroMAT^® is a platform that automates typical benchtop analyzers. Reliable approved automation components enable high operational availability. Online HPLC with BaychroMAT^® has been established in chemicals and polymers for many years. An innovation project within Bayer Technology Services was started in 2005 to expand the BaychroMAT^® platform to biotech industries, with the main focuses of development on:

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: BaychroMAT® SamplingValve integrated into the INGOLD port of a steel fermenter

: BaychroMAT® SamplingValve – a steam-sterilizable Online Port

Development of a sterile sampling valve (online port)
Adaptation of BaychroMAT^® to GMP requirements
Online cell counting with a Cedex analyzer (Innovatis AG)
Online titer and aminoacids via HPLC (Agilent, Shimadzu)
Online glucose and lactate determination (YSI)
Online medium determination (CuBiAn by Innovatis AG)

Sterility is the key to successful online cell counting

Sterility requirements for fermentation processes are extremely stringent. This is particularly true for sample extraction, as there is a risk of contamination each time a sample is taken. Nevertheless, it is nearly impossible to characterize the course of fermentation completely without sampling. The near-time, continuous monitoring of all critical parameters can only be ensured by means of a fully automated analysis system. This system has to include a steam-sterilizable sampling valve.

: Cedex data (viable cell count) of fed-batch fermentation and perfusion fermentation (comparison of online data versus lab data)

More data – greater safety

BaychroMAT^® enables reliable sterile sampling and therefore data acquisition around the clock. Data formerly only available once a day by inprocess control can now be used for real time monitoring, modeling and titer prediction, and to establish the optimal time to stop your fermentation. The following data are now available online

Cedex data: Viable cell count, viability, cell diameter…
HPLC data: Titer, amino acids, IgG, peptides, proteins
Online information about your C-source: glucose, glutamine, glycerol, acetate…
Online medium information: lactate, phosphate, ammonia, glutamate, LDH…

: Continuous improvement with BaychroMAT®: Online sampling enables real-time monitoring, modelling and titer prediction as well as optimal process adjustment.

Quality by Design – BaychroMAT^® is the solution

Since 2002, the FDA has encouraged manufacturers in the pharma/biotech industries to implement process analytical technologies. Up to now, only a few examples are known due to the lack of robust technologies. BaychroMAT^® changes this situation and Quality by Design becomes reality. More data – greater safety, reduced human error, fewer incident reports and an overall PAT data concept – this will be the future if you work with the BaychroMAT^® bioplatform.