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Introduction to Pharmaceutical Biotechnology, Volume 2 (Second Edition)
and implanted chips for ongoing surveillance of numerous health conditions. The
current trajectory in bioelectronics is focused on developing devices that possess
biocompatibility, flexibility, and multimodality. In recent years, there has been a
proliferation of commercially available wearable and implanted technologies
designed for healthcare purposes. These technologies can monitor various physical
signals, including heart rate, muscle movement, and electrocardiography, among
others. The simultaneous measurement of physical qualities and underlying
biological processes is of utmost importance for the functionality of biosensors.
A biosensing device that operates in real time can continuously detect and
produce reversible signals in response to changes in analyte concentration [130].
Consequently, it can distinguish signals between the analyte and interferants within
a complicated sample matrix. In addition, it can promptly deliver the analyte’s realtime signal without the need for supplementary procedural actions. The current
obstacle in utilizing biosensors for ongoing molecular monitoring is converting
targeted analyte data into continuous output signals that can be measured within a
living organism while mitigating any potential interference from background signal
drift. The successful implementation of the detecting device necessitates the
utilization of functional units. For instance, integrating a component on the sensing
interface with antifouling capabilities can significantly mitigate nonspecific adsorption, hence improving the signal-to-noise ratio. In the context of continuous
molecular monitoring in vivo, radiometric measurement is advantageous in mitigating background drifting, enabling the development of calibration-free biosensing
systems [131]. The glucose continuous monitoring system is an illustrative instance
of biosensors in continuous molecular monitoring. The objective of developing
biosensors that do not require reagents and can provide continuous monitoring of
various bioanalytics, including hormones, medicines, peptides, and proteins, in
clinical samples for real-time healthcare applications has not been fully achieved. In
addition to achieving continuous monitoring through chemical means, developing
wireless and Bluetooth signal readout technologies is also crucial for enabling
continuous in vivo monitoring. This project investigates the collaborative integration
of many fields, including biological materials, biosensors, bioelectronics, biological
engineering, and the web of things, intending to promote collaboration across
disciplines [132].
5.10 The Implementation and commercialization of
biosensing devices
The ongoing COVID-19 epidemic has led to a substantial surge in the need for costeffective and dependable laboratory diagnostics, particularly in countries with low
resources. Transitioning laboratory-developed biosensors for commercial application poses significant challenges due to the substantial disparity between scientific
understanding and routine medical practice. Integrating assays and devices is crucial
to enhancing their adaptability for practical applications. Two significant challenges
hinder the transition of benchtop technologies from the laboratory to the market:
there are two key processes involved in the progression of scientific advancements
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Introduction to Pharmaceutical Biotechnology, Volume 2 (Second Edition)
from laboratory-based technologies to clinical investigations and, subsequently, the
translation of these clinical studies into practical applications within the field of
medicine [133]. Contemporary scientific investigations prioritize successfully navigating the initial obstacle, which may be effectively addressed by optimizing
laboratory technologies. The viability of the new assays/devices is contingent
upon the market effect, as their acceptance by end-users and payers is crucial.
Before being introduced into the marketplace, laboratory-developed tests or instruments are required to comply with regulatory requirements, which include the
guidelines established by the US Food and Drug Administration (FDA). Ensuring
laboratory findings’ accuracy, reliability, and appropriateness is of utmost importance, regardless of the tested site. Techniques created in laboratories must meet
specific performance criteria before they may replace FDA-approved or cleared
diagnostic procedures. These criteria include a reported spectrum, quantitative
sensibility, clarity, analytic preciseness, accuracy, and an adequate comparison
interval [134]. To get past the second issue, it is vital to consider what the market
wants and needs. In places with limited resources, the monitoring system needs to be
accurate, reliable, easy for people to employ, and cheap for them. The reported
spectrum, analytical sensibility, precision, analysis particulars, accuracy, and
reference interval are only a few of the required performance criteria that
laboratory-developed technologies must exhibit before they can be used as FDAapproved/cleared results [135]. To effectively surmount the second barrier, it is
essential to consider the distinct prerequisites and expectations of the market. In
contexts with limited resources, it is critical for a system for detection to exhibit
accuracy, resilience, and ease of use while also being cost-effective for end-users. The
desirability of simplified and integrated detection systems lies in their potential to
facilitate the translation of sensing technologies into commerce. However, they
encounter many obstacles and necessitate dependable standardization of assays and
devices for these in vitro diagnostics. Therefore, it is imperative to foster collaborative endeavors among chemists, engineers, biologists, and clinicians to elucidate
the intricate path from laboratory experimentation to practical implementation of
biosensors in clinical settings [136].
5.10.1 Sustainability to the ecosystem
Disposable sensors are currently experiencing a surge in popularity due to their
affordability and the increasing demand for prompt, convenient, and dependable
health-related data in our interconnected society. In contamination prevention, the
imperative for employing single-use sensors is paramount. Although disposable
biosensors offer ease and rapidity, they also raise ecological problems. Incorporating
electrical components is necessary to enhance the intelligence of biosensing devices.
Achieving biodegradability in biosensors and biochips is significant [137]. The
necessity to develop a biosensing system that is smarter, more user-friendly, costefficient, and environmentally friendly has been underscored by recent discoveries in
the field of sustainable sensing systems. These discoveries include wearable devices,
paper-based biochips, smartphone-based detection, and recyclable biosensors.
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Introduction to Pharmaceutical Biotechnology, Volume 2 (Second Edition)
Researchers are committed to developing sustainable materials and methods for
sensors. An instance of the development of distance-based biosensors on filter paper
is observed, wherein these biosensors enable instrument-free semi-quantitative
examination. In addition, paper-based devices provide several advantageous characteristics, including their affordability, flexibility, and capacity to conduct point-ofcare testing with changeable signal reading [138]. Moreover, biodegradable silk or
hydrogels have been extensively employed in biosensing devices. Developing a
sustainable sensing system encompassing all desired qualities poses a significant
challenge. To create advanced and intelligent biosensing devices or bioelectronics
with optimal analytical performance, it is crucial to strike a balance that ensures
sustainability within the ecosystem [139].
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IOP Publishing
Introduction to Pharmaceutical Biotechnology, Volume 2
(Second Edition)
Enzymes, proteins and bioinformatics
Ahmed Al-Harrasi, Saurabh Bhatia and Ajmal Khan
Chapter 6
Biotransformation and enzymes
6.1 Introduction
Microorganisms have the tendency to enzymatically alter a wide range of organic
compounds. Biotransformation (bioconversions or microbial transformations)
widely refers to the processes in which microorganisms convert organic substances
into structurally related products. Biotransformation deals with microbial (enzymatic) transformation of a substrate into a product with a limited number of (one or
a few) enzymatic reactions. This is in comparison to fermentation which includes a
number of reactions (often complex in nature). Although a number of biotransformations are recognized, only particular reactions are valuable for the production of
commercially important products. The implication of bioconversion reactions
becomes evident when the synthesis of a certain compound is either difficult or
costly using chemical approaches. In addition, biotransformations are usually
considered for chemical reactions because of substrate specificity, stereospecificity
and mixed reaction conditions (pH, temperature, pressure). The environmental
pollution due to biotransformation is virtually insignificant or negligible. Moreover,
it is easy to apply rDNA technology to make suitable changes in biotransformations. Another practical benefit of biotransformations is that it is very easy to scaleup the procedures due to the restricted number of reactions.
6.2 Types of biotransformation reactions
Different types of chemical reactions occur during biotransformations, such as
oxidation, reduction, hydrolysis, condensation, isomerization, formation of new C–
C bonds, production of chiral compounds and reversal of hydrolytic reactions.
Among these, oxidation, isomerization and hydrolysis reactions are more commonly
observed in biotransformations. Other biotransformations involve more than one
type of reaction. Some examples of significant biotransformation reactions along
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