Better control, healthier yields: biotech process analytical technology


Source: Mettler - Toledo Int. Inc

METTLER TOLEDO recently published a white paper entitled “Process Analytical Technology (PAT) for Biotech: A Review of Recently Reported Applications in Fermentation and Bioprocessing.” The paper explores how Process Analytical Technologies, or PATs, help optimize fermentation and bioprocess actions critical to pharmaceutical, specialty chemical, commodity chemical, and bulk fuel development and manufacturing.

“PAT instrumentation, with applications from the laboratory to produc¬tion scale, helps ensure bioprocesses are performing as designed to maximize batch yield and productivity,” said Mr. Redman.

Effective screening and optimization for bioprocess development requires accurate monitoring and tight control of operating conditions. The METTLER TOLEDO literature review determined that PATs such as in situ monitoring are being used effectively to optimize bioprocesses in a manner unachievable by traditional methods of offline sampling.

Mr. Redman explained, “In our analysis, it became clear that for complex cell systems, where flocculation and aggregation alter biomass concentration, sim¬plistic measurements such as turbidity and optical density do not capture the entire picture. Systematically applied PATs, on the other hand, enhance process controls for better consistency.

“Measurements such as Focused Beam Reflectance Measurement® [FBRM] provide precise particle population measurements sensitive to changes in cell count, dimension and shape, each of which has been directly correlated to biomass. Morphologic change mechanisms and their kinetics are better quantified, which allows for real-time cell population control,” he added.

Benefits were found across all processes reviewed, including fermentation, biocatalysis, peptide synthesis, and protein and peptide crystallization. Crystallization – whether protein or small molecule – requires consideration of process parameters that impact crystal nucleation, growth, and agglomeration. Real-time particle characterization has become standard PAT from early solubility curve determination to critical process optimization ensuring consistency in scale-up.

Advanced PATs help identify relevant parameters for optimizing chemical synthesis as well. Study results explored the relative influence of temperature and reagent concentrations on yield and selectivity while avoiding the cost and time delay involved in withdrawing, preparing, and analyzing samples on an ongoing basis.

“Across multiple processes and industries, PATs are being used to help ensure fermentation and bioprocessing exercises yield desired outcomes. The result is fewer pre-process experiments and more effective scale-up,” concluded Mr. Redman.
To download a complete copy of “A Review of Recently Reported Applications in Fermentation and BioProcessing” for free, visit [web address].

METTLER TOLEDO specialists Urs Groth, Fabio Visentin, Dominique Hebrault, Ben Smith, Des O’Grady, and Brian O’Sullivan assisted principal author Terry Redman in the white paper’s creation.

METTLER TOLEDO’s global net¬work of technology and application consultants possess extensive research and industry experience supporting bioprocess development and scale-up. Visit METTLER TOLEDO at for information on our products/services and an extensive list of upcoming and on-demand webinars.

METTLER TOLEDO provides the enabling technology, software and people that can help build a seamless workflow to translate bench scale chemistry into a commercial process. For more than 20 years, our enabling tools and services have been a strategic resource providing critical information for thousands of development scientists and engineers. Companies have used that knowledge to accelerate the discovery, development and scale-up of new chemical processes spanning the chemical and biopharmaceutical industries.

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