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

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Temperature data loggers have been around for decades and were one of the first...

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

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Navigating the Immunotherapy Supply Chain: Advances in Transport Validation

Immunotherapies are an increasingly complex set of treatments for a wide variety of diseases...

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Cell & Gene Transport Sim Transport Simulation

Navigating the Immunotherapy Supply Chain: Advances in Transport Validation

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

Immunotherapy, the process of strengthening a patient’s own immune system using pharmaceuticals, is rapidly...

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Cell & Gene Cold Chain Engineering Regulatory Filing

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

Blockchain Applications in Pharmaceutical Serialization

While blockchain is typically associated with bitcoin or other cryptocurrencies, it is actually a...

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

Blockchain Applications in Pharmaceutical Serialization

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

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

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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Biologic Cell & Gene Drug-Device Combo Products Emergency Response Emerging BioPharma Pharmaceutical Public Health CROs Regulatory Filing Service Providers

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