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

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

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

Three Departments Working Together for Cold Chain Success

How do you go about integrating your cold chain and what is involved? To...

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

Three Departments Working Together for Cold Chain Success

Solid User Requirements Is First Step in Supplier Selection

Did you know there are at least 30 different suppliers of thermal packaging and...

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

Solid User Requirements Is First Step in Supplier Selection

Deviation Torture; Part 2.

Okay, if you’ve read part one of deviation torture, you know the terror of...

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

Deviation Torture; Part 1

January and August were busy months when I worked in a large pharma company...

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

User Requirements Specification (URS) Matrix Tool

The beginning of any good engineering project — be it an insulated shipper, designing...

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

User Requirements Specification (URS) Matrix Tool

The ISTA 7E Thermal Profiles and How to Make Them Work Regionally

The ISTA established a set of standard thermal profiles known as 7E using sound...

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