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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The True Cost of Advanced Therapy Logistics

Cost conversations in biopharma cold chain often start in the wrong place. Teams focus...

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The True Cost of Advanced Therapy Logistics

Why Advanced Therapy Supply Chains Are So Complex

Advanced therapies do not move through the supply chain the way traditional drugs do....

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Why Advanced Therapy Supply Chains Are So Complex

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

Lifting the Weight of Development: The Project Management Support That Helps Functional VPs Sleep Better

In the highly regulated and fast-moving world of biopharmaceutical drug development, cold chain logistics...

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Lifting the Weight of Development: The Project Management Support That Helps Functional VPs Sleep Better

How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic

When your mAb or other biologic is moving through the Biologics License Application (BLA)...

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How to Avoid an FDA Form 483 or a Warning Letter for Your mAb or Other Biologic

Ship, Quarantine, or Discard: A Streamlined Process and Analytical Tool Yields Better Decisions on Resolving Temperature Excursions

It’s estimated that seven out of ten pharmaceutical products in the US require temperature...

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Ship, Quarantine, or Discard: A Streamlined Process and Analytical Tool Yields Better Decisions on Resolving Temperature Excursions

How Artificial Intelligence Is Improving the Pharma Supply Chain

Artificial intelligence (AI) will transform the pharmaceutical cold chain — not in the distant,...

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How Artificial Intelligence Is Improving the Pharma Supply Chain

The New Reality of Accelerated Paths to Commercialization and Its Impact on Cold Chain Supply

With five FDA programs speeding drugs through approval to commercialization, the pace of scale-up is accelerating, shortening time to market by months...

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The New Reality of Accelerated Paths to Commercialization and Its Impact on Cold Chain Supply

Orphan Drugs: A Lifeline for Patients with Rare Diseases Can Bring Cold Chain Challenges

The Orphan Drug Act of 1983 (ODA) defined orphan drugs as a drug intended...

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Orphan Drugs: A Lifeline for Patients with Rare Diseases Can Bring Cold Chain Challenges

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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