PharmaceuticalOutsourcingQ42020 - 36


Safe Transportation of
COVID-19 Vaccines:
Challenges and Solutions
Gary Hutchinson, President and
Daniel Littlefield, Principal
Modality Solutions

The race for safe, efficacious COVID-19 vaccines is on, with an estimated
66 vaccine candidates in the clinical trial phase and many more in the
preclinical drug development phase worldwide.1 While there is great
urgency to find effective preventative measures and therapeutics for
SARS-CoV-2, the virus that causes COVID-19, the drug discovery and
manufacturing development process is just one piece of the puzzle.
Once a vaccine candidate has been deemed efficacious and safe,
has received regulatory approval, and has been manufactured in the
significant quantities needed, another hurdle remains: Transporting
the vaccine in a manner that preserves its integrity.
The cold chain requirements for COVID-19 vaccines will present a
myriad of challenges. Fortunately, the industry's experience with
other modern vaccines, combined with technology-based transport
validation solutions, provides a roadmap for successfully transporting
these vital drugs.

Understanding the Obstacles

impact) can serve as an energy input into a large, three-dimensional
molecule, with the potential to alter it chemically. Shock (which
involves short-duration, high-amplitude impact) can shear off part
of the molecule, reducing its efficacy or introducing particulates that
can cause adverse events.
In addition to the complexities of any large molecule drug, COVID-19
vaccines will pose other logistical issues. Given the urgent need
to stem the pandemic's tide, these vaccines are being developed
under the Coronavirus Treatment Acceleration Program (CTAP)
specially created by the US Food & Drug Administration (FDA) to
move new treatments to patients as quickly as possible. When
vaccines and therapeutics move through the drug development
and regulatory processes on an accelerated timeline, researchers
tend to take a conservative approach, particularly when it comes
to temperature tolerance.

Figure 1. Large Molecule mAb

The complexities of transporting a COVID-19 vaccine begin from the
nature of these therapies and the challenges associated with any
therapy developed on an accelerated timeline.
Traditional vaccines - like those designed to eradicate childhood
diseases - use either an inactivated virus (as with polio, influenza,
hepatitis A, and rabies) or an attenuated virus (as with measles,
mumps, and chickenpox) to spur antibody development. Modern
vaccines take a more sophisticated approach, using large, complex,
fragile molecules to power the immune system to target and thwart a
virus or other disease. The larger the molecule, the more susceptible
it is to damage, notwithstanding the limited protection provided by
the molecule's lipid proteins.
As with other large molecules, a vaccine is particularly sensitive to
shock and vibration - two hazards that can jeopardize drug safety
and efficacy. Vibration (which involves repetitive, low-amplitude
Pharmaceutical Outsourcing |


| October/November/December 2020



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
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
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PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
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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