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

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

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

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