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

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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Cell & Gene Cold Chain Optimization Transport Sim Transport Simulation

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

Executive Insights with Rob Battista

We sat down with Rob Battista, Engineering Manager, to dive into his insights on...

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Cell & Gene Cold Chain Optimization Engineering Consulting

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

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

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

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

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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AI-Driven Biologic Cell & Gene Cold Chain Optimization Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

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

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

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

Apheresis Collection for CAR T-Cell Therapy Requires Agility in the Cold Chain

Innovations in Cancer Immunotherapy Autologous cell therapy (ACT) is a therapeutic intervention that uses...

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Cell & Gene Cold Chain Engineering Engineering Consulting Transport Simulation

Apheresis Collection for CAR T-Cell Therapy Requires Agility in the Cold Chain

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

For thousands of years, tissue regeneration has been a topic of interest among the...

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Cell & Gene Emergency Response Regulatory Filing