A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing

Abstract

As competition in the biopharmaceutical market gets keener due to the market entry of biosimilars, process analytical technologies (PATs) play an important role for process automation and cost reduction. This article will give a general overview and address the recent innovations and applications of spectroscopic methods as PAT tools in the downstream processing of biologics. As data analysis strategies are a crucial part of PAT, the review discusses frequently used data analysis techniques and addresses data fusion methodologies as the combination of several sensors is moving forward in the field. The last chapter will give an outlook on the application of spectroscopic methods in combination with chemometrics and model predictive control (MPC) for downstream processes.

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

“…Data pretreatment is a key consideration when implementing any MVDA technique (Lopes & Sarraguça, 2018). In the context of vibrational spectroscopy and chemometrics, the preprocessing of the spectra removes variance that does not contribute any meaningful information in the data set (Rolinger, Rüdt, & Hubbuch, 2020). Data pretreatment techniques are dependent upon several factors such as the type of spectroscopy instrument, the concentration of the analyte of interest, the complexity of the matrix and the method of data collection.…”

“…Data pretreatment techniques are dependent upon several factors such as the type of spectroscopy instrument, the concentration of the analyte of interest, the complexity of the matrix and the method of data collection. However, the most common preprocessing steps for Raman, mid‐IR, and near‐IR spectroscopy include spectral smoothing, and corrections for baseline, background, and scatter (Rolinger et al, 2020). Background correction minimizes the effects of varying backgrounds caused by optical and matrix effects, and derivatives eliminate a constant offset and slope.…”

“…Background correction minimizes the effects of varying backgrounds caused by optical and matrix effects, and derivatives eliminate a constant offset and slope. Savitzky–Golay filters are the most commonly used techniques for smoothing and taking derivatives with vibrational spectroscopic tools (Rolinger et al, 2020). A detailed discussion of data pretreatment techniques is out of scope in this review, since it has been discussed extensively elsewhere (Lopes & Sarraguça, 2018; Rolinger et al, 2020).…”

High-Throughput Raman Spectroscopy Combined with Innovate Data Analysis Workflow to Enhance Biopharmaceutical Process Development

“…As described extensively in a review by Rudt. et al [32], and more recently in Rolinger et al [33], each of these spectroscopic techniques has its own set of advantages and applications.…”

Monitoring Thermal and Non-Thermal Treatments during Processing of Muscle Foods: A Comprehensive Review of Recent Technological Advances

“…Qualitative and quantitative applications of vibrational spectroscopic techniques are well established in the food industry [128][129][130][131][132][133][134][135][136][137][138][139][140]. Vibrational spectroscopy (infrared; IR, Raman) has been one of the most attractive and commonly used methods of analysis as it allows for simultaneous, rapid, and non-destructive determination of major components in many agriculture-related products and plant materials [128][129][130][131][132][133][134][135][136][137][138][139][140]. Mid (MIR), near infrared (NIR), and Raman spectroscopy are classified as molecular/vibrational spectroscopy techniques and they are used to evaluate and study the interactions of electromagnetic waves with a sample.…”