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.

Emergency Response

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

Radiopharmaceutical Logistics: Managing Decay, Timing, and Precision in Advanced Therapies

Radiopharmaceuticals operate under one defining constraint: time is a non-negotiable asset. Unlike traditional biopharmaceuticals,...

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Radiopharmaceutical Logistics: Managing Decay, Timing, and Precision in Advanced Therapies

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

How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

At a Glance Why IRs Happen: The FDA often requests additional information during NDA/BLA...

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Emergency Response Regulatory Filing

How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

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

Modality Solutions Focuses on Supply Chain Validation and Cell Therapy Clinical Trials at SBE Conference

Modality Solutions presented at the Society of Biological Engineers (SBE), part of AICHE (American...

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Cell & Gene Emergency Response Regulatory Filing

Modality Solutions Focuses on Supply Chain Validation and Cell Therapy Clinical Trials at SBE Conference

COVID-19 and the Race to Get a Vaccine Through FDA’s Supercharged Fast Track Approval Named Coronavirus Treatment Acceleration Program (CTAP)

The Coronavirus Treatment Acceleration Program launched by the FDA in response to COVID-19, is...

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COVID-19 and the Race to Get a Vaccine Through FDA’s Supercharged Fast Track Approval Named Coronavirus Treatment Acceleration Program (CTAP)

How Biosimilars’ Early Stability Testing Can Accelerate FDA Approval and Commercialization

Biosimilars have been a point of contention within the pharmaceutical industry for the past...

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Biologic Emergency Response Regulatory Filing

How Biosimilars’ Early Stability Testing Can Accelerate FDA Approval and Commercialization

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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