Intact protein analysis in the biopharmaceutical field

Staub, Aline; Guillarme, Davy; Schappler, Julie; Veuthey, Jean‐Luc; Rudaz, Serge

doi:10.1016/j.jpba.2011.01.031

Cited by 159 publications

(119 citation statements)

References 114 publications

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“…Chromatography is a very mature technology, is widely adopted, and has been reviewed in great detail elsewhere. [8][9][10][11] BioPharma's other workhorse technique for chemical/ compositional analysis is mass spectrometry (MS), a technique that involves the creation of ionized fragments of the target-molecule and the separation of the ions according to their mass-to-charge ratio. [12][13][14] Mass spectrometry techniques are often coupled with chromatographic separation techniques producing methods that have very high analyte resolution which are often the best means of characterizing complex biological samples in detail.…”

Section: Analytical Technologies In the Biopharmaceutical Industrymentioning

confidence: 99%

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review

2017

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The production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein-and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoing since the 1970s. Biopharmaceuticals (or biologics) are manufactured using biological-expression systems (such as mammalian, bacterial, insect cells, etc.) and have spawned a large (>E35 billion sales annually in Europe) and growing biopharmaceutical industry (BioPharma). The structural and chemical complexity of biologics, combined with the intricacy of cell-based manufacturing, imposes a huge analytical burden to correctly characterize and quantify both processes (upstream) and products (downstream). In small molecule manufacturing, advances in analytical and computational methods have been extensively exploited to generate process analytical technologies (PAT) that are now used for routine process control, leading to more efficient processes and safer medicines. In the analytical domain, biologic manufacturing is considerably behind and there is both a huge scope and need to produce relevant PAT tools with which to better control processes, and better characterize product macromolecules. Raman spectroscopy, a vibrational spectroscopy with a number of useful properties (nondestructive, non-contact, robustness) has significant potential advantages in BioPharma. Key among them are intrinsically high molecular specificity, the ability to measure in water, the requirement for minimal (or no) sample pre-treatment, the flexibility of sampling configurations, and suitability for automation. Here, we review and discuss a representative selection of the more important Raman applications in BioPharma (with particular emphasis on mammalian cell culture). The review shows that the properties of Raman have been successfully exploited to deliver unique and useful analytical solutions, particularly for online process monitoring. However, it also shows that its inherent susceptibility to fluorescence interference and the weakness of the Raman effect mean that it can never be a panacea. In particular, Raman-based methods are intrinsically limited by the chemical complexity and wide analyte-concentration-profiles of cell culture media/bioprocessing broths which limit their use for quantitative analysis. Nevertheless, with appropriate foreknowledge of these limitations and good experimental design, robust analytical methods can be produced. In addition, new technological developments such as time-resolved detectors, advanced lasers, and plasmonics offer potential of new Raman-based methods to resolve existing limitations and/or provide new analytical insights.

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Section: Analytical Technologies In the Biopharmaceutical Industrymentioning

confidence: 99%

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review

2017

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“…A single analytical technique for the characterization of biologicals is generally not sufficient [54,55].…”

Section: Direct Analytical Characterization Of the Productsmentioning

confidence: 99%

Analytical characterization of NOTA-modified somatropins

Bracke

Wynendaele

D׳Hondt

et al. 2014

Journal of Pharmaceutical and Biomedical Analysis

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Highlights• NOTA-labeled somatropins were synthesized using different NOTA:protein ratios.• Direct LC-MS and CE-MS approaches indicated multiple substitution degrees.• Bottom-up approaches gave structural insights and information on the labeling yield.• Lys-70 (in silico calculated pKa of 8.3) is the NOTA-modification hotspot.• We report a synthesis procedure for the production of target-specific radiopharmaceuticals.

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“…Thanks to the major breakthrough of modern biotechnology, new analytical technologies to characterize and ensure the safety of the source and end product application have been developed (Staub et al 2011). Today, escalating growth of commercial manufacturers of stem bromelain (retrieved from http://www.chemicalbook.com) worldwide has swiftly found usage in a wide array of industrial applications such as food, textile, brewing, cosmetic, and dairy products (Polaina and MacCabe 2007).…”

Section: Introductionmentioning

confidence: 99%

Bromelain: an overview of industrial application and purification strategies

Arshad

Amid

Yusof

et al. 2014

Appl Microbiol Biotechnol

168

134

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This review highlights the use of bromelain in various applications with up-to-date literature on the purification of bromelain from pineapple fruit and waste such as peel, core, crown, and leaves. Bromelain, a cysteine protease, has been exploited commercially in many applications in the food, beverage, tenderization, cosmetic, pharmaceutical, and textile industries. Researchers worldwide have been directing their interest to purification strategies by applying conventional and modern approaches, such as manipulating the pH, affinity, hydrophobicity, and temperature conditions in accord with the unique properties of bromelain. The amount of downstream processing will depend on its intended application in industries. The breakthrough of recombinant DNA technology has facilitated the large-scale production and purification of recombinant bromelain for novel applications in the future.

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Intact protein analysis in the biopharmaceutical field

Cited by 159 publications

References 114 publications

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review

Analytical characterization of NOTA-modified somatropins

Bromelain: an overview of industrial application and purification strategies

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