Bioprocess applicative lab

A powerful PAT tool

process analytics

Quality by Design (QbD), promoted by reglementary agencies, requires to define a design space where production parameters could vary without product quality degradation during the development of bioprocesses. This is achieved through increased process understanding with robust measurements of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).  QbD implementation in biopharmaceutical manufacturing is complex and requires specific and adapted Process Analytical Technology (PAT) tools. Raman spectroscopy technology is a non-destructive, swift and robust method to simultaneously measure multiple analytes. This is why Raman Spectroscopy has become a preferred PAT solution in the development and manufacturing of biopharmaceutical products to simultaneously monitor in-line and in real-time multiple CPPs and CQAs with a single probe.

In production, Raman spectropscopy can offer a robust mean of automation to provide a process under control.

Appplications

Upstream process monitoring

Scientific performing measurements with Raman bioprocess analyzerWidely used in USP, Raman enables to monitor in-line and in real-time many parameters such as cell density (total and viable cell densities), glucose, ammonium, lactate, glutamic acid and protein titer. All parameters are simultaneously monitored with a single probe inside the bioreactor. Raman also enables contamination early detection.

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In-line monitoring of nutrients and metabolites of a CHO cell culture with ProCellics™ Software

Automatic closed-loop feeding

For cell culture, in-line and real-time Raman monitoring enables to implement a nutriment (e.g. glucose) feedback control loop via an OPC connection between ProCellics™ Software and the software running the bioreactor.

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For cell culture, in-line and real-time Raman monitoring enables to implement a nutriment (e.g. glucose) feedback control loop via an OPC connection between the Raman software and the software running the bioreactor.

Antibody production

Monoclonal antibodiesDuring mAb manufacturing process, Raman enables to monitor in-line and in real-time antibody concentration, aggregation and glycosylation.

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Viral vaccine production

VirionFor vaccine manufacturing, Raman enables to monitor in-line and in real-time viral particle concentration and virus inactivation without any sampling.

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Single-use bioprocessing

Single-use sterile connectorRaman PAT tools can be easily used with single-use technologies. A sterile connector, such as Kleenpak™, enables to safely connect ProCellics™ Raman probe with a single-use container.

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Downstream processes monitoring

Widely used in USP, Raman is also a promising PAT tool for DSP. Coupled with chromatography, Raman enables to monitor in real-time product and by-product concentrations. HCP, titer, DNA digestion, aggregation and glycosylation are among the parameters which can also be monitored by Raman spectroscopy.

In Process Development, the analytical lab bottleneck can be fixed by Raman implementation.

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Benefits of ProCellics™ Raman analyzer in DSP chromatography systems

Parallel batches monitoring

The Raman Multi-Channel Unit enables to operate up to 4 probes from a single analyzerProCellics™ Multi-Channel Unit enables to operate up to 4 probes from a single analyzer. It allows both to monitor several batches in parallel and to build models much faster.

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