Newsletter | June 30, 2022

06.30.22 -- Calculating Process Control ROI For Improved Costs And Timelines

Calculating Process Control ROI For Improved Costs And Timelines

The degree of savings a biopharma can expect from adopting process analytical technologies (PAT) can vary widely and depends upon several factors, from the scale of a process to the value of a drug product. Understanding how multifaceted variables interact to influence PAT selection can help companies identify technology solutions that maximize both quality and cost-efficiency.

Balancing Conservative vs. Progressive Approaches To Enable Biomanufacturing Quality By Design

Increasingly, biopharmaceutical companies have begun to incorporate QbD approaches that utilize inline monitoring to achieve continuous process verification, process control, or real-time release. Real-time release necessitates a more conservative approach to PAT implementation, whereas process control and continuous verification may necessitate a more progressive approach. Determining which approach to take is critical to a process control strategy.

Light-Induced Fluorescence Sensing For Biotherapeutics Process Control Applications

Real-time light-induced fluorescence (LIF) has and continues to be an emerging PAT for biopharmaceutical GMP process monitoring and control, due to its unique superior sensitivity, low concentration (low dose) detection, and rapid response capabilities. We review an established photometric LIF sensor that has been applied to routine process monitoring and control GMP applications.

Protein Fluorescence Analyzer

Monitoring protein concentrations by measuring their intrinsic fluorescence is an excellent method because it is rapid, simple, and requires no expensive dyes or labeling. CST’s Protein Fluorescence Analyzer contains a PX2+ UV Photometer that uses optical filters to provide specific excitation/emission wavelength ranges chosen to coincide with protein fluorescence.

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Protein Absorbance Analyzer

Quantifying or identifying the absence or presence of proteins by directly measuring UV absorbance provides for fast, convenient results, which are critical for biopharmaceutical and bioprocess applications. CST offers photometers that monitor proteins exclusively at 280 nm or a dual wavelength photometer capable of monitoring at 260 nm and 280 nm simultaneously (other wavelengths available upon request).

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