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.

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Unlocking FDA Insights: Exploring Open Data Files for Shipping Validation

Are you aware of the open data files published online by the FDA? This...

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Unlocking FDA Insights: Exploring Open Data Files for Shipping Validation

A Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain Management Systems

Biopharma supply chain excellence starts by integrating your cold chain. By integrating your cold...

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A Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain Management Systems

A Cold Chain Process Validation Guide: Part 1: Introduction to Cold Chain Process Validation

Introduction The integrity of cold chain management is pivotal in the demanding realm of...

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A Cold Chain Process Validation Guide: Part 1: Introduction to Cold Chain Process Validation

Is it Necessary to Perform Analytical Testing After PQs?

Executive Summary: As clients choose Modality Solutions as their trusted cold chain consultants and...

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Is it Necessary to Perform Analytical Testing After PQs?

The Negatives of Real-World Shipping Studies for the Biopharma Cold Chain

Executive Summary: There’s a time and a place for Real-World Shipping studies, but when...

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The Negatives of Real-World Shipping Studies for the Biopharma Cold Chain

The Importance of Evaluating the Impact of Distribution for mRNA Therapies

by Carson Dickey, Senior Consulting Engineer and Sarah Williamson, Consulting Engineer mRNA therapies are...

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The Importance of Evaluating the Impact of Distribution for mRNA Therapies

The No-Brainer Alternative to Real-World Shipping Tests

“You don’t know what you don’t know.” Why outsource your cold chain validation? Modality...

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The No-Brainer Alternative to Real-World Shipping Tests

Non-Standard Modes of Transportation for Cell & Gene Therapies | Executive Insights with Carson Dickey

Recently, while attending the Allogenic Cell Therapy Summit in Boston, MA, Carson was at...

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Non-Standard Modes of Transportation for Cell & Gene Therapies | Executive Insights with Carson Dickey

Modality Solutions: Regulatory & Transport Simulation Insights with Andrew Larrigan

We sat down with Andrew Larrigan, Technical Operations Manager, to dive into his insights...

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Modality Solutions: Regulatory & Transport Simulation Insights with Andrew Larrigan

Monjuvi® Brings New Optimism for Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Patients Worldwide

On July 31st, 2020 the FDA has approved tafasitamab-cxix, officially named Monjuvi®, in combination...

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