Medical Manufacturing & Outsourcing - Version A. April 2021 - 16

Diagnosing COVID-19

Process Verification and Validation.
Throughout COVID-19 antigen test
production, it's crucial to verify
quality, performance, and consistency
at regular intervals. As it scales up
manufacturing, the CMO will validate
that the test is still performing
properly lot-to-lot, device-to-device.
This ensures diagnostic accuracy
and reliability, regardless of whether
it's the five-thousandth test to be
produced or the five-millionth.

Conclusion
A COVID-19 antigen test typically includes multiple layers of materials that must be laminated
together before they are inserted into the test cartridge. Reel-to-reel laminating equipment enables
precise alignment, which is necessary for predictable results. (Credit: Web Industries Inc.)
The fluid then flows across the device's
sample pad, which has been treated
with conjugate and reagent chemistries.
This prompts a chemical response to
the test specimen. The test is then
inserted into a small, portable testreading device to obtain the results.
The following step-by-step overview
of the LFI test manufacturing process
is an example of the process flow when
a CMO engages with an OEM or other
device developer to take a COVID-19 test
to commercial-scale production volumes.
Pre-Process Activities and Process
Development. First, the CMO and OEM
embark on their technology transfer
process.3 The CMO will perform supplier
assessments, confirming that the right
materials are available in the right
format to run optimally on high-speed
automated manufacturing lines. The
CMO will develop standard operating
procedures for how to mass produce
the test. Materials will be procured
and inspected, and manufacturing
process trials and testing will begin.
Biochemistry Lab. In an on-site
laboratory, the CMO takes the device
developer's proprietary test recipe -
the conjugate and reagent chemistries
- and prepares them in the quantities
needed for large manufacturing batches.
The reagent is one of the substances
on the test strip that causes a chemical
reaction when it comes in contact with
16 APRIL 2021

the test specimen. In some LFI tests, the
specimen might be blood or urine. For
COVID-19 tests, the specimen is usually
extracted from nose or throat mucous.
Reagent Deposition. At this stage,
the reagent is striped, or coated,
onto the test strip materials. The
deposition may involve precision
spraying or dip coating of blocking
agents, conjugates and other sample
pad treatments. Auto-mated reel-toreel (R2R) equipment enables efficient
processing, in-line inspection, and
reject marking. Reagent deposition
is performed in an environment with
controlled temperature and humidity.
Lamination. Next, the treated
materials must be laminated together
and slit into individual test strips. Here
again, R2R automation allows for
computerized vision inspection at high
speeds while the materials are laminated
and slit. This step must be performed
in a low-humidity environment.
Assembly and Packaging. Finally,
the test strips are placed into
cassettes, or housings. For optimal
manufacturing speed, efficiency, and
consistency, this step ideally should
be performed on robotic lines with
automated reject management.
The manufacturing configuration
can include automatic pouching so
that tests are ready for shipment as
they come off the assembly line.

Testing is crucial in the fight to
control COVID-19 and keep people safe
as this pandemic runs its course. With
the right supply chain alliances and
automation, COVID-19 antigen tests can
be manufactured in the large quantities
required by the United States. LFI
antigen tests provide results rapidly, at
or near the point-of-care. These test
results help individuals, businesses,
and governments make important
decisions that affect not only personal
health and employment but also the
well-being of entire communities,
companies, and the national economy.
References
1. Tromberg BJ, Schwetz TA, Pérez-Stable
EJ et al., " Rapid Scaling Up of Covid-19
Diagnostic Testing in the United States -
The NIH RADx Initiative, " N Engl J Med,
Special Report, July 2020. Accessed
July 28, 2020, from https://www.nejm.
org/doi/full/10.1056/NEJMsr2022263.
2. Coronavirus Testing Basics. FDA. Updated
July 16, 2020. Accessed August 12, 2020,
https://www.fda.gov/consumers/consumerupdates/coronavirus-testing-basics#.
3. C. Hanna, M. Conary, " Demystifying
Technology Transfer in Medical Device
Contact Manufacturing, " Medical Design
Briefs, Vol. 9, No. 3, March 2019, https://
www.medicaldesignbriefs.com/component/
content/article/mdb/supplements/
mmm/features/articles/34023.

This article was written by
Claudio Hanna and Jennifer Ponti,
business development managers for
Web Industries Inc., Marl-borough, MA.
They can be reached at
channa@webindustries.com and
jponti@webindustries.com.
For more information, visit
http://info.hotims.com/76508-347.

MEDICAL MANUFACTURING AND OUTSOURCING SPECIAL REPORT

http://info.hotims.com/79412-1004 http://info.hotims.com/79412-1005 http://info.hotims.com/79412-1006 http://info.hotims.com/76508-347

Medical Manufacturing & Outsourcing - Version A. April 2021

Table of Contents for the Digital Edition of Medical Manufacturing & Outsourcing - Version A. April 2021