PharmaceuticalOutsourcingQ42020 - 37

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Any biologic is sensitive to temperature, so tight temperature
controls are always necessary to maintain their integrity. Because the
first-round COVID-19 vaccine candidates were developed on a fast
track, employing conservative formulation stability strategies, they
will likely need to be stored in a deep-frozen state, typically defined
as below -60°C. From a transportation standpoint, that usually
means packing and shipping the vaccine in dry ice. By comparison,
many established vaccines can be safely stored and transported at
refrigerated temperatures of 2-8° C.
Another important consideration in transportation is a good
understanding of the interaction of temperature, vibration, and
shock. While any of these individually can cause product damage,
they do not necessarily work independently of each other. This
possible interaction emphasizes the importance of concurrent
testing to investigate those transport activities which can result in any
combination of significant vibration activity (e.g., long transportation
lanes), temperature excursions, and multiple shock events (e.g.,
frequent manual handling or mode changes).
Controlling temperature and reducing the risk of vibration and
shock throughout the cold chain is of the utmost importance when
transporting modern vaccines and other therapeutics. While the safe
transportation of COVID-19 vaccines will prove difficult, the industry's
experience with the Ebola outbreak in sub-Saharan Africa in 2015
demonstrates that it can be done effectively.
Much like COVID-19, the Ebola vaccine required storage in a deepfrozen state to avoid damage and preserve integrity. Once properly
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37

thawed and reconstituted, it could only be refrigerated for up to 12
hours prior to dosing. The associated transportation and distribution
problems were successfully solved, demonstrating that supply chain
networks can be designed, executed, and monitored amidst very
formidable logistical obstacles. Though the COVID-19 pandemic
is occurring on a much larger scale than the Ebola outbreak, the
blueprint for its safe transport exists.

Testing the Cold Chain Strategy
Safe and rapid distribution of a vaccine is critical to stemming the
tide of the coronavirus pandemic. But before an approved COVID-19
vaccine can be shipped to healthcare providers, regulators must be
assured that the pharmaceutical company's cold chain plan is sound
and feasible. Among their requirements, regulators such as the
FDA require pharmaceutical companies and other drug makers to
perform transport validation studies on the final formulation of the
drug, which typically happens concurrent with phase III clinical trials.
Additionally, initial transport validation may be done on engineering
batches or before a final formulation decision is made, enabling the
company to appraise multiple candidate formulations early in the
drug development process.
This is the point at which the scientists' drug discovery and
development work is handed off to engineers and logisticians to
determine how to protect the drug throughout the cold chain.
Through rigorous risk assessments, these professionals work to find
the optimum intersection of the drug product and the supply chain,
| October/November/December 2020


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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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