APPLICATIONS OF INTERNET OF THINGS IN PHARMACEUTICAL INDUSTRY

Shanmugarathinam Alagarsamy*1, Ruckmani Kandasamy1, Latha Subbiah1 and Selvamani

Palanisamy

*1 Department of Pharmaceutical Technology,Bharathidasan Institute of Technology, Anna

University, Tiruchirappalli, Tamil Nadu. PIN - 620024.
Email: shanmugarathinam@gmail.com

ABSTRACT

The pharmaceuticals and life sciences industries are generally require quite advanced
technology to compete with the worldwide market share. Pharmaceutical and life science
companies invest more time, effort and money into digitalization of their business. It is
estimated that by 2020, there will be 50 billion connected devices, and in five years, 80% of
companies are expected to utilize IoT in their digitized firms. IoT revolutionizes the
pharmaceutical sector by providing and automating pharmaceutical manufacturing, discovery
of drugs and remote monitoring of patients and more. Digitization holds tremendous potential
to help pharma companies address various challenges. This chapter intends to provide an
insight of Internet of Things in Pharmaceutical sectors.

Key Words: IoT, Pharmaceutical Manufacturing, Drug Discovery, Clinical Trials.

INTRODUCTION

IoT is defined as network of internet connected objects which is able to collect, analyse and
exchange vital information via installed sensors. It is estimated that by the end of 2020 there
may be 50 billion devices will be integrated. In the next five years, 80% of companies are
expected to utilize IoT in their organization to bring out the automation in every segment. IoT
has the potential for entirely modernizing the pharmaceutical sector by enabling and
automating discovery of drugs, clinical trials, monitoring the patients remotely, its access and
more.

The revolution of Industry 4.0 demand faster and easier access to healthcare services.
Alongside the pharmaceutical companies are also required to expedite the manufacturing
process, transport of medicine in safe and secure mode in better regulated transit and

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delivery. These processes generate huge data, harvesting these data and analyzing will be
efficiently maintained and used for analytics for future process and up gradations. Evaluation
of acquired data yields valuable insights into plant workflows, predicts maintenance needed
for the equipment before it becomes nonoperational conditions, track the supply chain
throughout the factory.

IOT IN PHARMACEUTICAL MANUFACTURING

Industry 4.0 is the digitalization of production, the term Industry 4.0 was used in public for
the first time at Hannover Messe in 2011. The term Industry 4.0, as defined by the German
Academy of Engineering and the Science and Industry Research Union, is the technical
integration of cyber-physical systems into production and logistics (1), as well as the
application of IoT and services in industrial processes including the resulting consequences
for value creation, business models and downstream services and work organizations.

Pharmaceutical manufacturing companies utilize the most advanced technology and

information systems. The process are monitored by multiple dedicated IT systems, some of
them are centralized. Whereas, some systems are local systems do not always cover
everything needed for quality manufacturing in a heavily regulated industry. In addition to
monitoring individual systems 360 (2) degree real time views of the plant operation across
multiple systems are needed. Automated gathering of date, and real-time IoT data analysis
from machines on the plant floors are also to be integrated. The ongoing challenge is direct
communication between departments, plant floor operations, and management which is due
to lack of real time integration around data to improve process flow and on time
manufacturing of product.

The term IoT suffixed with PM, Internet of Things for Pharmaceutical Manufacturing, IoT-
PM, has the power to radically change how pharmaceutical manufacturing plant operates. It
gives access the manufacturing activities be monitored from any remote location at any given
point of time. Thus the real time monitoring enables minimizing waste, increasing equipment
utilization, and lowering production costs. Connecting the process, product and people is said
to be Industrial IoT, undoubtedly manufacturing sector is the biggest beneficiary. Equipments
might have connected already, IoT is an added perk which uses the power of data and
computation prowess (3). This generates valuable insights of the plant workflow, keeps tracks
and manages the equipment performance much ahead of breakdown.

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IoT steer the pharmaceutical manufacturing sector towards a paperless environment with
lesser manpower (4). IoT implementation would make a fundamental shift towards outcome
based targeted therapies which to be performed by individualized production methods. Thirty
percent of the top 20 pharma companies have adopted IoT technologies in their
manufacturing process wherever possible. IoT-PM is recently implemented in a Canadian
based pharmaceutical manufacturer, Apotex, improved its manufacturing processes through
automation. They implemented tools such as automated guided vehicles, RFID tracking,
sorting and process flow tracking enabled the company which ensures consistent batch
production. To survive and grow in this competitive business the chemical and
pharmaceutical companies need to make product development and production more
efficiently using IoT-PM. Equipment and machines are becoming more digitalized with
ability to connect over the internet (5). Manufacturers are looking forward to advance
operational efficiency and to withstand competitive markets to lead the business as well as
provide services at competitive costs.

New environment are created establishing networks between machines, humans, and the
Internet. The major uses of IoT in the manufacturing plant covers the following points.

 Predictive maintenance: It covers all connected assets in manufacturing plants. It is

possible to anticipate machine failures and respond quickly to critical situations.
Algorithms can be developed with machine learning process by analyzing the data
gathered over a period of time. These helps to take decision on timely manner.
 Connected Factory: It says that the entire factory network is connected to the Internet
with the ability of full monitoring and controlling the situation.
 Connected Mine: In this all the mining operation, vehicles and personal safety
equipment are connected.
 Supply Chain Control: This part monitors the storage conditions, and tracks the
supply chain of resource materials to feed the machine and product tracking for
traceability purposes.

Fewer applications of IoT in the pharmaceutical manufacturing and supply chains are listed
below (6)

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  Smart serialization which automatically identifies objects, collects information and
feed it into the system.
 Forecasting maintenance of machines & equipment.
 Individualized Medicine.
 3D Printed Drugs.
 Real-time logistics visibility using RFID & sensors to capture and report parameters.
 Smart warehousing and routing.

IoT technologies implemented in pharmaceutical manufacturing plant to achieve optimization

and improve efficiency of their machines and processes. Thus reduces time and human error
and produces huge data during the process which shall be scrutinized for analysis. IoT
adopted systems share information across the plant floor, facilitate standardization by
connecting equipment, networks, and systems.

IoT was successfully implemented in top companies(7) such as Johnson & Johnson whereby
they able to obtain FDA approval for an HIV medication Prezista, shifting from batch to
continuous manufacturing. They eliminate the need for separate testing and sampling steps in
the manufacturing process using the sensor technology. IoT enabled those separate processes
to be interlinked, thereby ensuring data integrity. Pfizer is continuously adopting IoT thus
establishes an integrated manufacturing process across majority of its major manufacturing
plants. Another mojor company Merck uses IoT techniques to analyze biologic process data,
leading to successful discovery of a setback in the manufacturing plant, which was causing
very high discard rates of a particular vaccine.

IoT facilitates and allows for modular automation in a manufacturing plant and production
shall be done as per the needs of market demands. Bottlenecks of several processes within a
plant shall be identified with the help of IoT. Equipments are used wisely and in routine
manner without keeping it dormant for longer period of time. Pharma major GSK’s
(8).adopting IoT and cloud computing technologies on their manufacturing sites, they are
switching from batch manufacturing to continuous flow processing wherever possible. The

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prime important goal is to gain advantage of technology to cutting cost and time in
manufacturing, increasing quality, and reducing plant size. The technologists are designing
engines to gather, store, and analyze huge amounts of data and mobilize those data in process
design and control efforts.

Pharmaceutical site managers are in line with learning manufacturing data, to ensure that
factories operate within validated performance parameters, can be used to support continuous
improvement of processes. These process leads to shift in the focus of data informatics from
compliance to competitiveness.

Outsourcing the work helps the pharma companies to expedite and personalize the work flow
as per their requirements without having difficulty in marinating the huge data, but data
integrity is still under questionable. IoT based MES(manufacturing execution systems)
adopted by Atachi Systems /4/, for pharmaceutical manufacturing which keeps the electronic
batch manufacturing record for various pharma companies without compromising data
integrity. IoT firm Tetra Science has initiated an IoT platform whereby all data from different
processes and equipment are stored into one single location. These accumulated data can then
be evaluated directly for analysis and decision-making which reduces upto 40% time for the
entire process. Unkonwn minor change in the pharma manufacturing process will lead to
drastic failure of the batch process which needs to face the stringent regulation of FDA. IoT
enabled process facilitates faster, data collection from various steps in a manufacturing plant,
required for the FDA for the purpose of continuous process verification

Implementing IoT technologies attain standardization, reduced cycle time and data integrity
within manufacturing plants, thereby facilitating the process of continuous manufacturing for
pharma companies Pharmaceutical companies utilizes IoT technologies in their
manufacturing plants to facilitate routine manufacturing. This technique helps Pharma
companines to significantly cut cost and time in manufacturing and enhance product quality.
IoT helps in the process of standardization of the manufacturing process along with data
integrity. IoT technologies provides visibility from production to distribution in a
manufacturing plant leading to increasing operational efficiency (9).

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Major Benefits of Internet of Things in pharmaceutical manufacturing are as follows:

 IoT acts as a catalyst for paperless production, as equipment and recipe parameters
become more closely connected and available, which needs less manual interventions.
 As the health care industry grows to diagnostic based therapies which necessitates
individualized production of medicine for smaller scale manufacturing using IoT.
 IoT able to acquire the data from various processes and connect complex equipment
which visualizes the insight of the process beyond performance and efficiency.
 Connects various equipments working on various plant floors, communicates with
each other and share information across the plant and upto top level management.
These offers opportunity to standardize the process easily.
 IoT enabled smarter plant offers solution to manufacturers, they can access the data in
real time for better monitor of the production and gain visibility for the point of
production to market reach.
 Manufacturers pull the data as and when necessary to track and trace process when an
issue occurs which cautions and speedy recall of the products from the market quickly
and efficiently.
 Quality by Design shall be successfully implemented and monitored using IoT and
gain clear understanding of the process which helps to improve safety and protect the
market value of the brand.
 Electronic batch records enable cheaper and quicker data interpretation without
affecting the routine process.
 Modularization of pharmaceutical production plant with IoT is the need of the hour.
IoT facility allows automation and scale production up or down according to the
market trends. This enables quicker production in obedience with the regulatory
guidelines for particular markets and regions.

Better understanding of IoT is required for both manufacturers and suppliers to use it
optimally. IoT is more often used for small solutions required for a particular point of
process, still its true potential is not fully realized.

Research and development scientist and process engineers are need to collaborate well to
understand the advances in manufacturing technology. They need to implement IoT when
deciding on new formulations or therapeutic delivery methods.

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Important aspect of IoT and automated system is how the people handles and interact with
the data generated during the process. These data types need to be segregated and to be
supplied to the concerned people only not to reveal to all the handlers to avoid over confusion
or misuse. Timely supplying of the data in innovative and effective ways to the concerned
people will be the key issues in handling the IoT enabled process and analytics. The
challenge of IoT implementation depends on forecasting the future manufacturing with
highly flexible with adaptable automated production.

IoT sensors have been increasingly installed in the various departments of the pharmaceutical
plant. These IoT sensors in pharmaceutical companies have been used successfully in
integrating data across various departments, including manufacturing units spread across
various locations. Thus with IoT sensors the companies are able to control everything that
occurs over the production unit, in real time and remotely. With continuous efforts of
companies to bring better efficiency and control, IoT leads to reduce the cost of production,
augment the uses of equipment and minimize the wastage.

Materials used in pharma industry are highly sensitive and to be handled in a controlled
environmental conditions. IoT sensors and trackers be used and for such instances and said to
track and control optimal conditions for handling biomaterials and chemicals also ensures
flawless equipment operation. Pharmaceutical industries not interested to shutdown
equipment in unplanned manner(10). They monitor round the clock real-time status to wisely
uses every segment of the industry to fulfill the market needs.

The internet of things does precisely that each machinery pieces across the plant facilities and
continuously updating their status information of components in all the equipment such as:

 Pressure gauges
 pH probes
 Air compressors
 Sterilizers
 Heat exchangers
 Multi-media filters
 Vacuum pumps

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The information provided by the IoT sensors be used for equipment maintenance and repair,
avoiding critical issues, minimizing downtime, and also ensuring workplace safety. This
gives a full view of the equipment utilization. IoT sensors installed on the environment of the
manufacturing plant are vital part while handling the biomaterials. Thus enables the
monitoring of environmental indicators such as

 Temperature
 Humidity
 Light
 Radiation
 CO2 level

Plant incharges continuously monitors the information and take appropriate measures as and
when necessary. Pharma companies neither realized just selling traditional medicines alone
neither support the growth of the company nor even sustain competitiveness. Thus they start
to move the concept of beyond pill(11). This created interest in utilizing new technologies
and business strategies leading to Pharma IoT. Nowadays pharmaceutical manufacturers
make sense of big data which is in the cloud thereby taking a timely decisions based on
information.

Privacy and Data Security are major threat to use IoT in Pharma industries. Quality and
safety of their products are the prime importance of every pharmaceutical manufacturer.
Substandard product shall have definite impact on consumer health and pull down the
manufacturer image to bottom line. Manufacturers are more concerned about their data
security that generated during the process and intellectual properties. Upgraded security
protocols are needed to be applied in every stage of data retrieval and storage and reduce the
visibility to all expect the concerned executives. In spite of these complexities companies
which confidently deploy systems will get the most benefits. Pharmaceutical industry should
practice more advanced cyber security protocols.

IOT IN DRUG DISCOVERY

The Internet of Things is not only about the gadgets, it is about the way they communicate to
one another and feel the real time connected experience(12). Artificial intelligence market of

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Health care in U.S estimated to be over USD 320 million in 2016 expected to grow 38%
more over the years(13). Among these values 35% investments accounts for Drug discovery
applications using artificial intelligence market. Now a days early stage of Drug development
are driven by Machine learning and artificial intelligence. Researchers are using machine
learning algorithms to reduce development time and build a strong and sustainable drugs
pipeline. With the advancement of Cloud computing, machine-learning algorithms have
already gained momentum in pharmaceutical labs. This forecasts the vision of the lab of the
future based on digital connectivity and focusing on bringing new drugs to the health care
markets (14).

Bringing new drugs to market takes around 12-14 years and requires huge investments.
Automating the process of drug discovery cut down the costs upto 70%(15). With the use of
artificial intelligencea London based Benevolent company identified two potential drug
targets for Alzheimer’s disease which attracted the pharmaceutical companies to look
forward their R&D to work on these methods. Drug design company Exscientia utilizes AI
platform for design and screening the compound to help drug discovery(16). They rapidly
synthesize and assay small volume of compounds which may assist to refine the models
developed and helps in newer designs. While hunting for new drugs IoT, cloud computing,
machine learning and other technologies helpful to give a solution quicker, cheaper and more
effective(17).

Rapid growth of data processing segments over last two decades the large data sets
availability leads to produce advanced algorithms through machine learning process which
facilitates drug discovery by collecting information from the equipments, clinical trials and
patients and converting them into categorically store over the cloud. These were analysed and
used in every steps of drug discovery process and the lead time, costs involved in drug
discovery process shall be drastically brought down. Traditional trial and error approach of
drug discovery process were shifted upside down, now companies are following patient
driven biology and data gathered from them to derive more-predictive hypotheses. The large
volume of data processed thorough artificial intelligence to find the patterns hidden in the
data sets.

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During drug discovery process using data sets, various information is interlinked to recognize
the behavior pattern of compound under scrutiny. It visualizes how it behaves for the medical
outcome of the patient for the compound under scrutiny for the already stored data. It is
expected that one out of thousand compounds initially found to be safe drug which becomes
an FDA-approved drug(18). Traditional method of drug discovery costs more and time
consuming. Convergence of newer technologies will lead the future of drug discovery.

Advanced intelligent hardware systems steers the drug discovery process and moving to
clinical trials.Internet of Things connects people, processes, data, and things over the internet.
Digital transformation comprises integrating information technology, operational technology
and data to enable better insights, optimize processes, and create productivities(19).
Researchers still struggle to exploit the full potential of digitalization cultural inertia rather
than technology holds them back. Along with inventing newer therapeutics and personalized
medicine, the companies are evolving and adapting for the digital transformation. IoT
implemented technologies enables to manufacture conventional and new drugs more
economically and triggers investments in more innovative methods for making drugs.

IoT based data analysis of drug discovery systems environment makes the repeatability of
studies smoother and reduces the human involvement and human error in the process and
tests(20). They increase the quality of the products through standardized systems.
Technologies facilitates the researchers working in drug development process to eliminate a
drug fails in early stages before getting into the process of clinical trial. They can either
modify the compound of interest to address the issues or discard the process; store the data
for future research works. The process of drug discovery not straight forward, it has to pass
through various stringent regulations to reach the market. As an average one out of ten
thousand compounds hits the market hence companies concerned about spending huge
investments on traditional method of drug development(21). Though the IoT has huge
potential in life science discipline, still many scientists are under incumbent level to use IoT
for their routine research work.

IOT IN CLINICAL TRIAL

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IoT allows manufacturers, marketers retailers to integrate data to optimize the clinical
outcomes of the patient which is great challenge. IoT is is becoming just as pervasive in the
field of clinical trials(22). Almost all the pharmaceutical companies, contract research
organizations , and service providers plan to increase their use of IoT to bring out the newer
drugs and biologics to the market in a shorter period of time and cut downs the huge
investments. Collecting data in novel ways with IoT and storing in the cloud provides better
understanding the safety and efficacy of investigational drugs under clinical trials. Site less
trials and monitoring patient in their home or at local clinic where data captured via devices
could be sent to cloud and accessed by clinical coordinators in real time. Number of patients
can be increased along with more geographic regions organisations can increase the number
of trials therefore the possibility of bringing new drugs to the market in faster manner.

The IoT based revolution in Life Sciences segment is in budding stages. Pharmaceutical and
biotechnology firms are in a situation to reach the clinical outcomes in a faster manner where
they spend millions of dollars and to harvest the benefits quickly. The concept of Ingestible
pills equipped with micro cameras are under trial, which monitors the dosage management
for the chronic diseases conditions(23). Whereby patient data continuously monitored and
tracked.

Clinical trials require complex designs and support of healthcare staff is prime requirements.
This is part of continuous monitoring and passing information during clinical trials.
Traditional method involves direct contact of the patient with healthcare staff to collect data
and other clinical outcome parameters. The involvement of IoT reduces these hurdles and it is
a boon to the firms involving in clinical trials. IoT in clinical trials has the ability to harvest
data in an efficient and effective way and able to analysis in a secure and timely manner. By
converging medical devices with IoT networks, clinical trial firms have the ability to watch
patients remotely. Parameters such as body temperature, hydration levels, sleep cycles, and
other daily activities are collected from the subjects passively and in real time. This method
of data capture ensures efficient and effective information transfer. This method of collection
of data using IoT possesses patients experience the clinical trial in friendly manner so that
they can do their routine work.

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IoT has transformative potential across the various life science disciplines (24). Adding
geolocation tag, micro environmental information to data sets, connects facilities across
research sites. The term internet of things is insufficient for which it is geotagged, remotely
monitored and interconnected which encompass instruments, animals, data and laboratory
workers. IoT have emerged for laboratory animal care as well which is under drug
development process. These animals are monitored using radiofrequency identification
platforms for tracking cage census. Newer type of cages issue alerts if any housing
parameters get worsen and put animals at risk. IoT offers to access environmental sensors and
data entry forms to monitor the animal wellbeing in real time. The parameters shall be
adjusted remotely across sites. During the animal study there is need to transport animal
between parties of research groups the benefit of IoT could be utilized for this transportation
systems which monitors the containers and track the data in real time. Animal study
informations are shared among the research groups on real time to work on their part of study
to bring out the speedy drug development process avoids the wastage of time and money. In
addition to animal husbandry and transportation IoT applications shall be extended to quality
assurance and compliance for animal experimentation. Clinical trials usesIoT devices which
are digital gadgets that collects and analyse digital biomarkers from patients(25).With the
advent of IoT Clinical trials to be more cost effective and efficient and patient friendly.

CONLUSION

IoT technologies are in its nascent stages of development in pharmaceutical industries, but its
impact across the global healthcare space is unquestionable. The companies those adopt IoT
technology will reap the benefits of the IoT. In reality low energy, low cost IoT networks and
solutions are still in early stages. This chapter outlined the IoT in pharmaceutical
manufacturing sector, drug discovery process and clinical trials.

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