Supply Chain

Advances in Real-Time Supply Chain

Operation Technology Can Address
Drug Product Security Challenges
Technological developments in real-time supply chain operations
provide biologics manufacturers with capabilities that go beyond supply
chain visibility to tangibly address security and quality challenges.
MAHESH VEERINA

T
he COVID-19 pandemic saw the global biopharma Security Act (DSCSA) and greater assurance that drug
supply chain thrust into center stage amid a perfect quality and security are safeguarded.
storm of high-profile disruptions, logistical challenges,
labor shortages, geopolitical instability, and shortages of cer- THE SIZE OF THE CHALLENGE
tain key ingredients, drugs, and equipment. These challenges According to the International Air Transport Association’s
compounded the legacy supply chain challenges biopharma- (IATA’s) Center of Excellence for Independent Validators in
ceutical manufacturers were already facing, such as tempera- Pharmaceutical Logistics, losses from the deliveries of vaccines
ture control failures resulting in spoilage, counterfeit drugs, exposed to temperatures outside their recommended range
and the black and gray markets for therapeutics. cost the industry approximately $34 billion annually (1). That’s
This paper seeks to quantify some of the major only one example of the significant waste stemming from
biologics supply chain challenges and how they can be misaligned logistics networks and limited visibility, automation,
resolved by resilient digital operations. When properly and control in pharmaceutical supply chain networks.
splitov27/Stock.Adobe.com

deployed, such an approach will improve overall supply Another study published in July 2022 by Forrester
chain visibility, enhance security, and assist with the fore- Consulting (2) on behalf of Rockwell Automation surveyed
casting and planning around problematic scenarios. These
improvements translate to greater ease in reporting the MAHESH VEERINA is the president and CEO of ParkourSC.
information demanded under the Drug Supply Chain

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Supply Chain

more than 300 global supply chain issue, regulatory agencies are demand- the legacy issues relating to therapeutics.
decision makers across a variety of ing more accountability. The DSCSA, Advances in supply chain technology
industries. The report found that of the for instance—first introduced by FDA can help biopharmaceutical companies
companies polled, “87% said counter- in 2013—is being updated to add meet these expanded requirements. The
feiting is problematic for their company, more stringent requirements related introduction of ‘big data,’ more robust
and nearly half (47%) said their com- to drug delivery, distribution, and dis- and secure instantaneous communica-
pany loses between 11% and 60% posal. Large-molecule drugs/biologics tion, the industrial internet of things
of sales income each year to coun- have specific parameters around man- (IIoT), artificial intelligence (AI), and
terfeiting” (2). Furthermore, “89% ufacturing, storage, and transportation. machine learning (ML)—allied to
said gray-market diversion is prob- Any deviation from those parameters advances in logistics, sensor technolo-
lematic for their company with 56% can result in adverse impacts, such as gies, and private secure networks—have
reporting that their company loses up significant batch loss due to tempera- spurred a number of important tech-
to 60% of sales income each year to ture control problems, and so forth. nological advances relating to real-time
gray-market diversion” (2). To protect patients, the DSCSA sets supply chain visibility.
Looking at the development and out the critical requirements needed to While having real-time visibility was
distribution of COVID-19 vaccines as build a comprehensive digitized system a significant step forward in the abil-
one example, the problems have been for tracking and identifying prescrip- ity to better secure drugs in the supply
persistent and significant. On a global tion drugs on sale in the United States, chain, technological innovations can be
scale, the World Health Organization phased in over a 10-year period. deployed that further minimize the risk
estimates that up to 50% (3) of vac- of losses and maximize the return on
cines are wasted every year. What’s Large-molecule investment of supply chain investments.
more, the Centers for Disease Control Developing and deploying a ‘real-time-
and Prevention reported that at least drugs/biologics all-the-time’ model to the supply chain
15 million doses (4) of the COVID-19 has been a priority that enables bio-
vaccine were wasted in just a six-month have specific pharmaceutical manufacturers to go
period in 2021. That’s a conservative beyond visibility, fully remove historic
estimate that doesn’t even cover all parameters around data silos, and create completely digi-
places that handle, store, and admin- tized end-to-end supply chain ecosys-
ister vaccines. In addition, there are manufacturing, tems that can meaningfully tackle both
cases where vaccines don’t pass quality new and legacy challenges.
inspection to begin with—including storage, and How does all of this translate on a
an account in The New York Times (5) practical level? Across the whole ecosys-
of nearly 400 million doses scrapped transportation. tem of customers, suppliers, and trans-
by a manufacturer due to poor qual- portation modalities, three fundamental
ity control. Much of this waste can be SUPPLY CHAIN TECHNOLOGY actions have been identified that can go
attributed to shortcomings in logis- INNOVATIONS PROVIDE a long way toward maintaining drug sub-
tics to support an unbroken cold chain. TANGIBLE SOLUTIONS stance and drug product integrity and
Finally, data published by McKinsey Historically, bio/pharmaceutical supply security, supporting current good manu-
(6) suggests that the pharmaceutical chains, like those of other industries, facturing practice compliance throughout
industry stands to lose an average of were somewhat siloed, which resulted the supply chain, and helping to meet
24% of one year’s EBITDA (earnings in a lack of visibility across the full sup- regulatory standards. Together, these
before interest, taxes, depreciation, and ply chain journey of drugs and thera- actions combine AI and ML with big
amortization) every 10 years due to peutics—from development to patient data monitoring and analysis and deploy
supply chain disruptions. and every step in between. This lack of across entire supply chains like a net. This
Clearly, none of this is good busi- visibility manifested in poor planning, produces actionable intelligence to drive
ness, nor is it sustainable in the long inaccurate predictions, and delayed tangible improvements in real-time sup-
term. The supply chain challenges decision-making, all of which increased ply operations and help minimize the
for biopharmaceutical manufacturers risk, led to waste, and eroded value for effect of disruption. The three actions are:
cost a great deal of pain, both finan- the organization (as detailed above). • The creation of ‘digital twin’ mod-
cially and in terms of reputation. Regulations in the biopharmaceuti- els of supply chain networks,
Therein lies the urgency to solve them. cal industry, such as the DSCSA, are enabling real-time operational
Recognizing the magnitude of the becoming more stringent to address modeling and monitoring.

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• Leveraging actionable intelligence which means that data can be taken supplier is one or more levels removed
to anticipate problem scenar- without problem from any connected from the core. With a network of dig-
ios, incorporate ground truth into device. The resulting ‘digital thread’ of ital twins, there is a common node
operations, and automate response connected data allows organizations to where the risk of duplication of effort
to potential disruptions. overcome data and organizational silos, can be identified and removed. This
• Empowering partners and sup- within their own company and across extendibility is important, especially
pliers to collaborate and optimize every other organization involved in the as it pertains to the ability to build a
the ecosystem to coordinate supply supply chain, and truly understand how network of digital twins across key sup-
chain operations at all stages; this well the entire supply chain is perform- pliers, map all the various dependen-
includes monitoring all assets and ing on a minute-to-minute basis. cies and relationships in their supply
inventory throughout the supply chain, and pull everything into a single
chain to continuously align plan- EMBEDDING real-time, collaborative supply chain
ning and execution with ground COLLABORATIVE SMARTS operational source. Production can be
truths to improve service levels. Embedding deep data and actionable modeled, managed, and mitigated, both
intelligence into digital twin models from a visibility perspective as well as
INTRODUCING DIGITAL TWINS further builds transparency and facil- extrapolating and predicting problems
A digital twin is a virtual representation itates approved cross-organizational and challenges that can occur.
of the entire supply chain ecosystem—a collaboration across all partners in the Moving forward, complete visibility
virtual map of assets across operations ecosystem. Any variance to set parame- and collaboration across supply chain
and business processes constructed from ters or disruptions to plans can be iden- partners and enterprises will be an
vast amounts of accessible, real-time, tified and flagged quickly. Deviances absolute requirement, as it enables the
ground truth data flowing across con- can be proactively triaged to give the identification and prevention of any
nected systems. Historically, digital twins best possible chance to prevent escala- potential problems that exist in several
were associated more with static analysis, tion, thereby improving resilience. nodes out of the extended ecosystem.
but now the concept has been success- The virtual nature of digital twins For example, the recent pandemic-gen-
fully operationalized to track many sup- also empowers supply chain ecosystem erated bottlenecks in the port of
ply chain dependencies to mitigate risks, partners to develop and run advanced, Shanghai. It’s possible that some of
automate workflows and corrective action, predictive scenario modeling. What this the materials that a biopharmaceutical
and drive better supply chain resilience. means is that organizations can virtu- company might purchase could even-
Mapping the entire biopharma supply ally model and test ‘what-if ’ scenar- tually pass through that port through
chain ecosystem in this way (i.e., every ios where disruptions may occur with a third-party logistics company that
component within the journey of a prod- potential actions and outcomes outlined. is several layers deep in the supply
uct) is the starting point of the ‘real-time- As these are virtual simulations, they chain network. If that port is backed
all-the-time’ supply chain model. Every are cost-effective and safe and provide up, the supply chain becomes disrupted.
constituent, regardless of which enter- invaluable intelligence. Organizations Having visibility into that issue to
prise they reside in, can be added digitally. can now prepare contingency plans for drive contingency plans is operation-
This digitization of the entire end-to-end supply chain failures, disruptions, and ally vital so that any disruption can be
supply chain means that organizations supply-demand fluctuations to model best managed and minimized.
can see where inventory is at any point and optimize operations. The digital twin mode can also be
in its journey, whether that be at the con- deployed at small scale to meet new
tainer, pallet, box, or individual package SUPPLY CHAIN EXTENSIBILITY challenges related to transitioning very
or vial level, from manufacturer to the AND FLEXIBILITY expensive specialized therapies from
patient if necessary. Once a supply chain ecosystem is fully low-volume, white-glove products and
Deploying digital twins, all con- digitized through digital twin technol- services to high-volume supply chain
stituents can be constantly monitored ogy, that ecosystem can be scaled and operations. Biopharmaceutical compa-
at multiple levels via any number of extended as needed. Building a network nies often acquire smaller companies
agreed parameters specific to opera- of digital twins that is extensible as that deliver specialized therapies such
tions. Deep signal and data intelligence more components are added to the sup- as cell and gene therapies, so creating
can be generated from any entity, sys- ply chain infrastructure can provide the a digital representation of that compa-
tem, or device and shared via interactive visibility required to highlight dupli- ny’s existing supply chain operations
dashboards in real time. The systems cate dependencies and sources for any
used are designed to be data-agnostic, given element, regardless of whether a Contin. on page 52

www.biopharminternational.com October 2022 BioPharm International 33

Ask the Expert

Ask the Expert — Contin. from page 54 Supply Chain — Contin. from page 33

difference between regulatory compliance and real com- and then faithfully transitioning that to the acquiring organiza-
pliance is having an organization chart that separates tion (and usually eventually to higher-volume operations) using
quality and operations vs. having that same organization digital twins can ensure quality, compliance, assurance, and
chart supported by SOPs that demonstrate quality has the continued on-time delivery. Companies can even gain visibility
responsibility and authority to operate independently. into the ‘last mile’ to ensure that the therapies are delivered and
Here’s a more practical example of regulatory compli- used as prescribed.
ance vs. real compliance. US 21 CFR 211.25(a) requires Lastly, when there are biopharmaceutical mergers, acquisi-
“Each person engaged in the manufacture, processing, tions, and spin-out companies—and if an enterprise has its
packing, or holding of a drug product shall have edu- existing supply chain ecosystems digitized—those functions
cation, training, and experience or any combination are much easier to transfer ownership. As each relationship is
thereof, to enable that person to perform the assigned mapped, every aspect of the supply chain is cataloged, and a
functions” (2). A regulatory compliance approach would record of the activities throughout the supply chain is main-
be to offer every employee annual GMP training and tained; thus, another entity can take over and integrate opera-
document their attendance. A real compliance approach tions quickly and easily.
would be to provide effective training to the employees by ‘Black swan’ events are unpredictable, and the biophar-
assessing their comprehension of the material and offer- maceutical supply chain challenges are a fact of business life.
ing follow-up training as necessary. However, technological developments are finally enabling
Another practical example of regulatory compli- manufacturers to tackle drug security and inventory losses
ance vs. real compliance is examining how a company while optimizing operations through the complete digitiza-
approaches investigations. A strictly regulatory compli- tion of the supply chain. Building digital twin ecosystems
ance approach to an investigation results in a firm not enable predictive modeling, real-time alerts, and the ability to
determining the true root cause of an issue because convene stakeholders across enterprises in a collective effort to
the focus is on completing the investigation in a self- safeguard drug quality, integrity, and security and enable bio-
imposed time frame instead of focusing on the quality pharma manufacturers to meet the stringent demands laid out
of the investigation. Real compliance organizations focus by measures, such as the DSCSA.
on determining the true root cause(s) and using that
information across their manufacturing facility to drive REFERENCES
continuous improvements and prevent recurrence of the 1. IATA, How to Become IATA Certified, International
Air Transport Association, Q4 2020.
deviation that prompted the investigation. 2. Rockwell Automation, The ROI of Increased
Taking a regulatory compliance only approach to opera- Traceability Automation, Rockwell Automation/
tions may be less expensive in the short term, but in the Forrester Consulting, accessed Sept. 8, 2022.
long term it will most likely result in more expenditure 3. WHO, Monitoring Vaccine Waste at Country Level, Guidelines
for Programme Managers, WHO/V&B/03.18 Rev.1.
to fix the problems that could have been avoided if a 4. J. Eaton and J. Murphy, “15 Million Covid Vaccine
real compliance approach was implemented throughout Doses Thrown Away in the U.S. Since March, New
the organization. Data Shows,” NBC News, Sept. 1, 2021.
5. S. G. Stolberg, C. Hamby, and S. LaFraniere, “Emergent
Hid Evidence of Covid Vaccine Problems at Plant,
REFERENCES Report Says,” The New York Times, May 10, 2022.
1. US Code, Federal Food, Drug, and Cosmetic Act, 6. McKinsey and Company, “Four Ways Pharma
Section 501(a)(2)(B). Companies Can Make Their Supply Chains More
2. US 21 CFR 211 ◆ Resilient,” McKinsey.com, Sept. 21, 2021. ◆

Ad Index
COMPANY PAGE COMPANY PAGE

Actylis..................................................................................................................7 Irvine Scientific.................................................................................................11

Catalent Pharma Solutions, Inc.....................................................................56 Mettler-Toledo Ingold, Inc...............................................................................35
Cygnus Technology, Inc...................................................................................2 Nova Biomedical.............................................................................................25
Emergent BioSolutions...................................................................................31 Spectrum Chemical Mfg Corp.......................................................................55
Entegris.............................................................................................................23 Tosoh Bioscience............................................................................................15
Eurofins Lancaster Laboratories...................................................................19 WuXi Biologics...................................................................................................5

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