| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1162792 | Analytica Chimica Acta | 2016 | 14 Pages |
•Principal analytical tools for analysis of recombinant drugs are presented.•A critical comparison among different substrates for fabrication of miniaturized systems is made.•Applications of miniaturized systems to produce recombinant drugs are shown.•Future trends of miniaturized systems capable of integrating analytical and proteomic tools in a single device are envisioned.
We present here a critical review covering conventional analytical tools of recombinant drug analysis and discuss their evolution towards miniaturized systems foreseeing a possible unique recombinant drug-on-a-chip device. Recombinant protein drugs and/or pro-drug analysis require sensitive and reproducible analytical techniques for quality control to ensure safety and efficacy of drugs according to regulatory agencies. The versatility of miniaturized systems combined with their low-cost could become a major trend in recombinant drugs and bioprocess analysis. Miniaturized systems are capable of performing conventional analytical and proteomic tasks, allowing for interfaces with other powerful techniques, such as mass spectrometry. Microdevices can be applied during the different stages of recombinant drug processing, such as gene isolation, DNA amplification, cell culture, protein expression, protein separation, and analysis. In addition, organs-on-chips have appeared as a viable alternative to testing biodrug pharmacokinetics and pharmacodynamics, demonstrating the capabilities of the miniaturized systems. The integration of individual established microfluidic operations and analytical tools in a single device is a challenge to be overcome to achieve a unique recombinant drug-on-a-chip device.
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