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.

Featured Resources

White Paper:
Simulated Transport Methodologies

Learn more about transport simulation - a highly effective methodology that can test your drug product formulation better than any “real-world” shipping study possibly can.

Download white paper

Blogs

Elevating Local Expertise & Trial Infrastructure in Remote Locations – Ensuring Cold Chain Success

Executive Summary Conducting clinical trials in remote locations poses additional vulnerabilities. A “Boots on...

Biopharma Cold Chain Resources

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White Paper: Simulated Transport Methodologies

Blogs

Elevating Local Expertise & Trial Infrastructure in Remote Locations – Ensuring Cold Chain Success

10 Years of Modality Solutions: What We’ve Learned, Part 2

10 Years of Modality Solutions: What We’ve Learned, Part 1

How to Successfully Respond to an FDA Information Request (IR)

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

Why Cold Chain Engineering is Vital to Transporting Monoclonal Antibodies (mAbs) and Other Biologics

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

Monjuvi® Brings New Optimism for Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Patients Worldwide

Is Your Supply Chain Prepared for the Coronavirus Vaccine?

How Transport Simulation Testing Benefits Fast-Track Approval Timeline

Prepare Your Post COVID-19 Clinical Trials in Four Steps

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

How Artificial Intelligence Is Improving the Pharma Supply Chain

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

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

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

Drones in Your Biopharmaceutical Supply Chain– Are You Ready?

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

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Navigating the Immunotherapy Supply Chain: Advances in Transport Validation

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

The Design of Clinical Trials in Pharmaceutical Development

Blockchain Applications in Pharmaceutical Serialization

The Impact of Setting the Temperature Control Unit (TCU) to a Cycled Setting

The Challenge of Developing a Clinical Trial for an Ebola Vaccine

Case Study: Meeting Cold Chain Logistics Challenges In Global Clinical Trials

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

A Potential Revolution For Passive Shipper Selection

Forecasted Cold Chain Trends for 2016

A Process Validation Guide for Cold Chain Logistics

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

Why Is Pharmaceutical Transportation a Major Concern?

Pharmaceutical Cold Chain Is Complex

The New and Improved ISTA Standard 20 v2

How to Use USP and ASTM to Evaluate Thermal Test Results

Define Your User Requirements Specifications Upfront to Ensure Success!

From the Mailbox…When is good enough, good enough?

Cold Chain Integrity Challenges Biopharmaceutical Industry

What Are the Correct Cold Chain Testing Standards for Your Biologic Packaging and Product Formulation?

Three Departments Working Together for Cold Chain Success

Solid User Requirements Is First Step in Supplier Selection

Deviation Torture; Part 2.

Deviation Torture; Part 1

User Requirements Specification (URS) Matrix Tool

The ISTA 7E Thermal Profiles and How to Make Them Work Regionally

Does ISTA 3A Really Simulate Transport?

How old is that trailer?

Trailer Definition

Every Quality Agreement Needs A Great Investigative Reporter

Integrate cold chain management systems?

Case Studies

Testing Performance and Assessing Cost-Effectiveness for a Pallet Shipper Provider

Modeling a Thermal Shipper to Optimize a Global Pharmaceutical Cold Chain

Cold Chain Challenges for Combination Device Product

Standardized Temperature Excursion Reporting Speeds Decision Making and Remediation

“First Principles” Thermal Modeling Improved Freeze/Thaw Operations

Packaging and Label Testing for NDA Application Support

New Drug Application (NDA) Support for a Temperature-Sensitive Drug

Establish Standard Operating Procedures To Ensure Compliance For A Refrigerated Mixed Load Trailer During Cold Chain Transport

Transport Validation Helps Ensure Drug Stability for Ocean Container Shipments

Case Study: How Transport Simulation Helped This ADC Therapy Achieve Fast-Track Approval

Robust Validation Planning and Transport Simulation Testing Support Accelerated Approval of an Innovative Monoclonal Antibody Cancer Therapy

Mitigating Biopharma Cold Chain Storage and Transport Risks for Ebola Virus Studies in Liberia, Africa

Environmental Sustainability for the Cold Chain

Creating a Cost-Effective, Regulatory Compliant CRT Cold Chain

Improve Passive Thermal Shipper Qualification Compliance

Expertise in Simulation Testing and Thermal Packaging Qualification Prepares Biosimilar for FDA Review Meeting

Addressing Temperature Excursions and Reducing Total Delivered Cost for an Innovative Combination Therapeutic

Creating a Comprehensive Cold Chain Strategy for EBOLA Vaccines in Sierra Leone

Shipping Lane Validation and Transport Simulation for Biosimilars Increases Confidence in BLA Filing

Plunger Movement Studies Helped Regeneron Confirm Drug Sterility and Meet Tight BLA Filing Timelines

A Comprehensive Look at Cold Chain Challenges and Solutions in a Global, Multimodal Logistics Network

White Paper:
Simulated Transport Methodologies

Drones in Your Biopharmaceutical Supply Chain– Are You Ready? 