Biopharma Cold Chain Resources

Whether you’re new to cold chain regulatory requirements or a seasoned expert in shipping validations, Modality Solutions offers expert perspectives on the biopharmaceutical cold chain industry.

Cell & Gene

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

Documentation strategy for your cold chain management validation practices has evolved over the last...

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It Is Never Too Late to Document Your Cold Chain Process Validation Approach

A Potential Revolution For Passive Shipper Selection

First published on April 20, 2015 on Cold Chain IQ – as a contributor,...

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A Potential Revolution For Passive Shipper Selection

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

First published on June 15, 2015 on Cold Chain IQ – as a contributor,...

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Biologic Cell & Gene Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers Transport Sim Transport Simulation

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

Why Is Pharmaceutical Transportation a Major Concern?

First published on May 11, 2015 on Cold Chain IQ – as a contributor,...

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Why Is Pharmaceutical Transportation a Major Concern?

Pharmaceutical Cold Chain Is Complex

First published on April 9, 2015 on Cold Chain IQ – as a contributor,...

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Biologic Cell & Gene Cold Chain Engineering Cold Chain Optimization Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

The New and Improved ISTA Standard 20 v2

The International Safe Transit Association (ISTA) is a member-driven standards organization. A revised version...

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ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

The New and Improved ISTA Standard 20 v2

How to Use USP and ASTM to Evaluate Thermal Test Results

To set the stage for this blog post, a thermometer is a device that...

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ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

How to Use USP and ASTM to Evaluate Thermal Test Results

Define Your User Requirements Specifications Upfront to Ensure Success!

Different people have different expectations while developing a drug product shipping solution – for...

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ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Define Your User Requirements Specifications Upfront to Ensure Success!

From the Mailbox…When is good enough, good enough?

Note to readers: I wanted to share the following email and reply, since it...

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ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

From the Mailbox…When is good enough, good enough?

What Are the Correct Cold Chain Testing Standards for Your Biologic Packaging and Product Formulation?

Many of the projects Modality Solutions work on for clients require thermal qualification for...

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Biologic Cell & Gene Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers Transport Sim Transport Simulation