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.

Regulatory Filing

A history of regulatory expertise at Modality Solutions

Prior to the start of Modality Solutions, the co-founders collaborated with their biopharmaceutical manufacturing...

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Regulatory Filing

A history of regulatory expertise at Modality Solutions

Modality Solutions provides advanced Cold Chain Regulatory Expertise

Regulatory Expertise – A Q&A with Gary Hutchinson From transport simulation expertise to regulatory...

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Cold Chain Engineering Regulatory Filing

Modality Solutions provides advanced Cold Chain Regulatory Expertise

EUA Risks for Pharmaceutical Companies

How FDA processes have adapted from questionable EUA approvals to more stringent follow-up processes...

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Emerging BioPharma Pharmaceutical Regulatory Filing

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

Agency Feedback Integrates Regulations, Industry Guidance, and Best Practices Across Global Cold Chain Jurisdictions

By Gary Hutchinson, President, Modality Solutions In 2021, Modality Solutions will be facilitating...

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Biologic Cold Chain Engineering Pharmaceutical Regulatory Filing

Agency Feedback Integrates Regulations, Industry Guidance, and Best Practices Across Global Cold Chain Jurisdictions

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 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 Promise of Antibody-Drug Conjugates (ADC) Comes with Additional Cold Chain Challenges

2020 saw a resurgence of antibody-drug conjugates (ADCs) with seven new approvals and close...

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Biologic Cold Chain Engineering Regulatory Filing

The Promise of Antibody-Drug Conjugates (ADC) Comes with Additional Cold Chain Challenges

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