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.

ASTM/ISTA

Advanced Therapy Logistics: Managing Temperature, Shelf Life & Time Sensitivity

Logistics is where advanced therapy programs meet reality. You can have the most precisely...

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Advanced Therapy Logistics: Managing Temperature, Shelf Life & Time Sensitivity

Pioneering Excellence in CMC Services for the Biopharmaceutical Cold Chain

In the ever-evolving landscape of the biopharmaceutical industry, Chemistry, Manufacturing, and Controls (CMC) services...

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ASTM/ISTA Cold Chain Engineering Emerging BioPharma Engineering Consulting Regulatory Filing

Pioneering Excellence in CMC Services for the Biopharmaceutical Cold Chain

Management: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

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ASTM/ISTA Cold Chain Engineering

Management: How to Implement ISTA’s PCG-03 Recommendations

Monitoring: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

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ASTM/ISTA Cold Chain Engineering Emerging BioPharma Pharmaceutical

Monitoring: How to Implement ISTA’s PCG-03 Recommendations

Scope & Timing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

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ASTM/ISTA

Scope & Timing: How to Implement ISTA’s PCG-03 Recommendations

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

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