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Raman application guide for thelife science industry
Trusted composition analysis forthe life sciences

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Bioprocessing applications

The Raman Rxn-45 probe for process and cGMP applications

Bioprocessing applications
Our leading bioprocess analytical solutions and comprehensive complianceofferings help you get your lab-to-process analysis right the first time
Endress+Hauser Raman systems, powered by Kaiser
Raman technology, provide in situ, real-time sensingof multiple parameters for cell culture and fermentation
bioprocesses. Our offerings for in situ bioprocess analytics
enable advanced bioprocess control. Our technology scales
for use in single-use or reusable bioreactors, in stirred-tankor perfusion, from lab to cGMP.

We provide a comprehensive portfolio of services for cGMP
applications including: questionnaire and audit support,
standard and customized IQ/OQ, Factory Acceptance
Testing (FAT), in-house audits, supplier qualification, andcGMP trained service personnel. We ensure quality for ourcustomers by investing in ISO 9001:2015 and hazardous
area certifications.

Raman bioprocessing applications
Application familyParameter

Application note title

Upstream cellculture bioprocessing

Glucose
LactateTiter
VCD...and more

Analysis of a mammalian cell culture
Cross-scale in situ Raman monitoring ofa cell culture
Raman-based nutrient control inbioprocessing
Raman-based advanced processcontrol in upstream bioprocessing forparameters beyond glucose

Upstream fermentation
bioprocessing

SugarsAlcohol
BioMass

Analysis of a batch fermentation process

Downstream cell
culture bioprocessing

Protein higher order structure

Downstream biopharmaceuticaloperations
In-line Raman monitoring of protein
crystallization

Contact Endress+Hauser for additional product and process related parameters.

Pharmaceutical applications

Pharmaceutical applications
We can help you deliver a transferable and efficient process from primary reactions
to continuous solids processing
Deliver consistent product quality from thebeginning Endress+Hauser’s Raman analyzer systems
provide in situ, real-time analysis of multiple components
with a single probe. Through this information, you can gain
process understanding, ensure the process is within control,and identify product quality surrogates supporting realtime release. Our Raman technology helps you to efficiently
and consistently deliver higher yield and improved productquality with reduced contamination risk.
Raman Rxn-20 probe for coating analysis

Raman pharmaceutical applications
Application family

Parameter

Application note title

Active pharmaceuticalingredient (API) manufacturing

Solid form identification(polymorphs, hydrates,solvates, transformations)Monitoring a pharmaceutical crystal
transformation in situ
Rapid monitoring of antisolvent addition
crystallization and dehydration
In situ monitoring of polymorphic transformationof active pharmaceutical ingredients
Quantifying anhydrate/hydrate using potential
PAT in situ techniques
Following a process-induced transformation
during granulation using in situ techniques
In-line monitoring of a pharmaceutical freezedrying process

Drug product manufacturing

Blend uniformity
Coating endpoint
monitoring
Continuous processing

Real-time quality prediction of continuously
produced pharmaceutical granules

Product quality

Quantification of a degradant in an intact
pharmaceutical tablet
Off-line and on-line Raman spectroscopy of APIcontaining extruded films

Wet granulation

Following a process-induced transformation
during granulation using in situ techniques

Contact Endress+Hauser for additional product and process related parameters.

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