PharmaceuticalOutsourcingQ42020 - 38

SUPPLY CHAIN

Table 1. Sample Cold Chain Testing Plan
Location
Lane

From

Simulated Transport Study Exposure Targets
To

Vibration

1

Fill/Finish CMO

Packaging CMO

Truck Profile (Non-Accelerated)

2

Packaging CMO

3PL

Truck Profile (Non-Accelerated)

3

3PL

Affiliate

Air Profile (Non-Accelerated)

Temperature
15° C
-4° C

Pressure

Time

Shock

Custom Ground Pressure Profile

10 hours

ISTA 3A Drop Cycles

Custom Ground Pressure Profile

22 hours

N/A

Custom Air Pressure Profile

Truck Profile (Non-Accelerated)

15° C

Custom Ground Pressure Profile

12 hours
8 hours

N/A

20 hours

4

Affiliate

Distributor

Truck Profile (Non-Accelerated)

-4° C

Custom Ground Pressure Profile

8 hours

N/A

5

Distributor

Hospital, Pharmacy

Truck Profile (Non-Accelerated)

15° C

Custom Ground Pressure Profile

20 hours

ISTA 3A Drop Cycles

Totals

100 hours

demonstrating to regulators that the drug can be transported to the
point of use on a large scale, while maintaining its safety and efficacy.

is unlikely for real-world testing to simulate the many scenarios a drug
might encounter in transit.

While the regulations vary by country, any developer of a COVID-19
vaccine or therapy will be required to demonstrate that it will maintain
a chain of custody throughout the supply chain by employing
consistent, repeatable processes that preserve the vaccine's integrity.
Transport validation is the critical part of that requirement.

Transport Validation Goes High-Tech

Historically, transport validation for vaccines and other therapies
was done in real-world settings - placing packages filled with a drug
product on trucks and planes and sending them across the globe.
Over time, the industry discovered that real-world shipments testing
has inherent limitations.

*	 A real-world shipping test does not allow for testing multiple
concurrent hazards. Yet, in the real world, each potential hazard
does not occur in isolation.

*	 In a real-world shipping test, the worst-case scenario will not
occur. However, a valid assessment should test the " worst-case "
edges of the intended operating space.

*	 A real-world shipping test does not allow for controlling

Critical feedback from the FDA and other regulators has created an
incentive for pharmaceutical and biotech companies to overcome
these limitations by conducting transport validation using more
rigorous methodologies. Over time, transport validation testing has
evolved and advanced significantly with the help of technology.
Today, the makers of COVID-19 vaccines and other biologics can use
technology-based simulation approaches to test the drug's physical
and chemical integrity, based on the actual hazards that will occur in
the field, to ensure there will be no risk of degradation during transit.
Degradation of a COVID-19 vaccine can result from two primary
causes: A change in chemical stability (e.g., the chemical properties
of the molecule are altered) or a change in physical stability (e.g., a
portion of the molecule breaks off and turns into particulates, or the
vaccine's lipid protein " unravels " too much while deep-frozen and
does not return to its original state once thawed for dosing).
A transport simulation study can determine if degradation occurs
after concurrent exposure to the five potential hazards drugs may

multiple variables in a way that makes the test both realistic
and repeatable.
Due to such limitations, a real-world shipping test on a COVID-19
vaccine will not be able to guarantee that the drug will experience all
possible hazards, at their peak, at the same time, or that the testing
experience can be repeated under identical conditions.

Figure 2. Controlled Transport Simulation and Validation
Using Cold Chain Engineering

Consider this example: A COVID-19 vaccine is driven by truck to an
airport in Los Angeles, California, then flown from Los Angeles to
Sydney, Australia, then driven to a clinic 15 miles away. That vaccine
has endured a long flight, but it probably has not been subject to
significant shock events since it was only dropped off and picked up a
couple of times. If the same vaccine is driven by truck from Temecula,
California to San Diego, then flown to Louisville, Kentucky, where it
takes a connecting flight to Columbus, Ohio and is then driven by
truck to Marietta, Ohio, it has a greater chance of enduring shock
because it has been picked up and dropped off more often. These
two scenarios present very different risks, underscoring the fact that it
Pharmaceutical Outsourcing |

38

| October/November/December 2020



PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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