Biopharma Cold Chain Resources

Antibody-Drug Conjugate (ADC) Logistics: Managing Potency, Stability, and Safe Handling

Antibody-drug conjugates (ADCs) are a revolutionary class of biopharmaceuticals that combine the precision of...

CMC and Quality in Advanced Therapy Supply Chains: Where Compliance Meets the Clock

There is a particular kind of pressure that comes with managing Chemistry, Manufacturing, and...

Cell and Gene Therapy Logistics: Managing Chain of Identity, Viability, and Coordination

Cell and gene therapies (CGTs) introduce a fundamentally different supply chain model, where every...

Stability in Advanced Therapies: Why It Drives Every Downstream Decision

Stability in Advanced Therapies: Why It Drives Every Downstream Decision In the world of...

Why Advanced Therapy Supply Chains Are So Complex

Advanced therapies do not move through the supply chain the way traditional drugs do....

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,...

Advanced Therapy Logistics: Managing Temperature, Shelf Life & Time Sensitivity

Logistics is where advanced therapy programs meet reality. You can have the most precisely...

Shipping ADCs with Confidence: Eliminating the Risks That Keep Program Leaders Up at Night

Antibody-drug conjugates (ADCs) represent some of the most promising, and most complex, therapies in...

Misalignment Is a Silent Killer—And the FDA Is Looking for Cracks

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

In This New Regulatory Landscape, You’re Either Ready—or at Risk

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

Cell & Gene Therapies Are Under the Microscope—And Few Are Passing

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

Simulation Data Is Still Accepted—But Now It Has to Be Flawless

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

Regulatory Shifts and Reviewer Turnover: What You’re Not Being Told

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

Zero-Defect Submissions: Securing First-Cycle Approval

FDA Uncertainty: Why First-Cycle Approval Is Now a Matter of Survival Leadership shake-ups, budget...

Part 2: Expanding Shipping Temperatures Without Sacrificing Quality: A Guide to Transport Validation and PQ

Demonstrating Product Quality All pharmaceutical manufacturers must ensure that the safety and efficacy of...

Part 1: The Foundation of Pharma Supply Chain Integrity

Introduction The integrity of supply chain management is pivotal in the demanding realm of...

No Temperature Controls Necessary For Small Molecules? Are You Sure?

Ensuring Quality for Small Molecule Therapy Supply Chains in a Growing Market Managing the...

More Than Cold Chain: How Modality Solutions Engineers a Full Spectrum of Supply Chain Success

At a Glance: Cold Chain Engineering: Modality Solutions focuses on enhancing drug delivery through...

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...

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...

Eliminating Logistics and Compliance Stress: How Reliable Cold Chain Partnerships Deliver a Good Night’s Sleep

In the tightly regulated and increasingly complex world of biopharmaceuticals, cold chain logistics represent...

What Keeps Functional VPs Up at Night? Strategic Cold Chain Guidance for a Good Night’s Sleep

In the highly regulated and complex world of biopharmaceutical drug products, ensuring cold chain...

Unlocking FDA Insights: Key Takeaways for Shipping Validation of Pre-Filled Syringes

Are you aware of the open data files published online by the FDA? This...

AI vs. Humans: Can Artificial Intelligence Outsmart Cold Chain Experts?

10 Common Misconceptions of Cold Chain Validation, as Explained by AI, commentary by Gary...

A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

Unlocking FDA Insights: Open Data Files for Successful BLA Submissions

Are you aware of the open data files published online by the FDA? This...

A Cold Chain Process Validation Guide: Part 5: Operational Qualification (OQ) for Drug Products

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

A Cold Chain Process Validation Guide: Part 4: Component Qualification / Installment Qualification (CQ/IQ)

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

A Cold Chain Process Validation Guide: Part 3: Developing Mature Quality Systems

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

Unlocking FDA Insights: Exploring Open Data Files for Shipping Validation

Are you aware of the open data files published online by the FDA? This...

A Cold Chain Process Validation Guide: Part 2: Integrating your Cold Chain Management Systems

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...

A Cold Chain Process Validation Guide: Part 1: Introduction to Cold Chain Process Validation

Introduction The integrity of cold chain management is pivotal in the demanding realm of...

Navigating New Regulatory Seas: Biopharma’s Critical Shift in Biologic Drug Production and Distribution for Rare Diseases

The biopharmaceutical industry is at a pivotal moment, particularly those involved in developing drugs...

Cold Chain Executive: How to be a Leader Instead of a Follower

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

The Importance of a Strategic Cold Chain Executive in your BioPharma Company

The biopharmaceutical industry faces a myriad of complex challenges in the delivery of life-saving...

Revolutionary Cold Chain Management built on Global Reach and Multidisciplinary Expertise

Reliable cold chain management is more critical than ever in today’s fast-paced and interconnected...

Pioneering Excellence in CMC Services for the Biopharmaceutical Cold Chain

In the ever-evolving landscape of the biopharmaceutical industry, Chemistry, Manufacturing, and Controls (CMC) services...

Supply Chain Optimization in the Biopharmaceutical Industry: A Strategic Imperative for Success

In today’s fast-paced and ever-evolving biopharmaceutical industry, optimizing the supply chain is not just...

Cold Chain Executive: Metrics and Network around a Biopharmaceutical Cold Chain Strategy

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

Elevating Cold Chain Excellence: Modality Solutions’ Consultative Expertise

Maintaining the integrity and quality of temperature-sensitive products has become an unyielding necessity in...

You Think You Know Modality Solutions? Think Again.

Modality Solutions is the leading engineering company that specializes in providing innovative and comprehensive...

Cold Chain Executive: Temperature Is Not The Only Concern

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

The Cold Chain Executive: Temperature Strategies

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

The Importance of Plunger Movement Studies in Biopharmaceutical Cold Chain Validation Process

In the realm of biopharmaceuticals, ensuring the safety and integrity of sterile injectables is...

Enhancing Thermal Packaging Performance: Evaluating Pre-Qualified Shippers for the Biopharmaceutical Industry

Executive Summary In today’s blog post, we will explore how heat transfer concepts can...

Cold Chain Executive: The Difference Between Biopharmaceutical Cold Chain + Supply Chain Strategy

The Cold Chain Executive: The reality of being a C-Suite or senior executive Biopharmaceutical...

Building Resilience in Cell Therapy Supply Chains: Ensuring Timely and Safe Delivery

Executive Summary In the fast-paced world of cell and gene therapies, building a resilient...

Cold Chain Tech Spotlight: SnowSHIP: Revolutionizing Cold Chain Technology

Welcome to Cold Chain Tech Spotlight, our blog series dedicated to unveiling the latest...

Management: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

3 Benefits of Modality Solutions Supporting Clinical Trials in Sub-Saharan Africa

Executive Summary: Modality Solutions’ involvement in sub-Saharan clinical trials brings the additional value of...

Is it Necessary to Perform Analytical Testing After PQs?

Executive Summary: As clients choose Modality Solutions as their trusted cold chain consultants and...

The Negatives of Real-World Shipping Studies for the Biopharma Cold Chain

Executive Summary: There’s a time and a place for Real-World Shipping studies, but when...

Acceptance Criteria: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

The Importance of Evaluating the Impact of Distribution for mRNA Therapies

by Carson Dickey, Senior Consulting Engineer and Sarah Williamson, Consulting Engineer mRNA therapies are...

Monitoring: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

5 Things to Expect from Your Cold Chain Consultant

A cold chain consultant is a critical element of any pharmaceutical filing and approval...

Shipper & Payload Bracketing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

Specialized Global Regulatory Expertise

Read the rest of our regulatory expertise series below: Part I: A History of...

Lane Bracketing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

Scope & Timing: How to Implement ISTA’s PCG-03 Recommendations

On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV)...

What Makes Modality Solutions Your Cold Chain Regulatory Experts?

Staying on Top of Regulatory Trends Modality Solutions is constantly scanning the environment for...

What is a Cold Chain Consultant?

Because the pharmaceutical cold chain is a specialized area of the pharmaceutical development process,...

Why outsource regulatory expertise?

As a pharmaceutical manufacturer, your in-house experts can only get you so far during...

A history of regulatory expertise at Modality Solutions

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

A New Class of Therapy: Monoclonal Antibody Fragments

Monoclonal Antibodies: Monoclonal antibodies (mAbs) are clones of the antibodies that our body secretes...

The Basics of Oligonucleotides

New classes Therapeutic Regulatory How our methodology works There are several exciting new classes...

C&GT is vulnerable to violent shock during transportation.

Modality Solutions is paving the way for the future of pharmaceutical transportation testing. The...

Modality Solutions provides advanced Cold Chain Regulatory Expertise

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

The No-Brainer Alternative to Real-World Shipping Tests

“You don’t know what you don’t know.” Why outsource your cold chain validation? Modality...

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...

Infographic: Checklist for Remote Trial Locations

How to prepare for remote trials when engineering knowledge isn’t enough.  What sets our...

Guns, Kidnapping, Ebola, and Vials: What it’s REALLY like to run a Clinical Trial in Remote Africa

WRITTEN BY KIMBERLY BRUE AN INTERVIEW WITH DAN LITTLEFIELD, MODALITY SOLUTIONS Recently, I sat...

Executive Insights with Rob Battista

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

Modality Solutions: Regulatory & Transport Simulation Insights with Andrew Larrigan

We sat down with Andrew Larrigan, Technical Operations Manager, to dive into his insights...

5 Common Oversights in Cold Chain Validation

Download the infographic here.

EUA Risks for Pharmaceutical Companies

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

Q&A: Regulatory Shifts in the Pharmaceutical Cold Chain

We sat down with Gary Hutchinson, President of Modality Solutions, to gather his perspective...

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...

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

In our previous post, we looked at some of the ways the biopharmaceutical industry...

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

Recently, we worked on a project for an advanced CAR T-cell therapy developed by...

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)...

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...

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

The global biologics market is forecast to reach $625 million by 20261, fueled by...

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...

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...

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

On July 31st, 2020 the FDA has approved tafasitamab-cxix, officially named Monjuvi®, in combination...

Is Your Supply Chain Prepared for the Coronavirus Vaccine?

You need a strategy to address the inevitable cold chain challenges caused by worldwide...

How Transport Simulation Testing Benefits Fast-Track Approval Timeline

Abstract: FDA Fast-Track designation compresses approximately eight years of development and validation activities into...

Prepare Your Post COVID-19 Clinical Trials in Four Steps  

Clinical trials around the world are being disrupted by the COVID-19 pandemic, leaving sponsors...

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...

How Artificial Intelligence Is Improving the Pharma Supply Chain

Artificial intelligence (AI) will transform the pharmaceutical cold chain — not in the distant,...

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...

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...

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...

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...

Drones in Your Biopharmaceutical Supply Chain– Are You Ready? 

Today drug product delivery via drone is no longer a fringe technology – it’s here to...

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...

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

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

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...

Navigating the Immunotherapy Supply Chain: Advances in Transport Validation

Immunotherapies are an increasingly complex set of treatments for a wide variety of diseases...

4 Challenges in Immunotherapy Drug Supply Chains and Logistics

Immunotherapy, the process of strengthening a patient’s own immune system using pharmaceuticals, is rapidly...

The Design of Clinical Trials in Pharmaceutical Development

Explore the Clinical Trial Design Including the Unique Cold Chain Logistics Challenges for Clinical...

Blockchain Applications in Pharmaceutical Serialization

While blockchain is typically associated with bitcoin or other cryptocurrencies, it is actually a...

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

The growing importance of refrigerated trailers in the pharmaceutical industry Refrigerated trailers in the...

The Challenge of Developing a Clinical Trial for an Ebola Vaccine

FHI 360 October 9, 2017 Feature Podcast On March 4, 2015, FHI 360 contacted...

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

First published on June 29, 2016 on Cold Chain IQ – as a contributor,...

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

Documentation strategy for your cold chain management validation practices has evolved over the last...

A Potential Revolution For Passive Shipper Selection

First published on April 20, 2015 on Cold Chain IQ – as a contributor,...

Forecasted Cold Chain Trends for 2016

First published on January 5, 2016 on Cold Chain IQ – as a contributor,...

A Process Validation Guide for Cold Chain Logistics

First published on September 16, 2015 on Cold Chain IQ – as a contributor,...

Dynamic Stability Testing Saves Time and Money in Your Cold Chain

First published on June 15, 2015 on Cold Chain IQ – as a contributor,...

Why Is Pharmaceutical Transportation a Major Concern?

First published on May 11, 2015 on Cold Chain IQ – as a contributor,...

Pharmaceutical Cold Chain Is Complex

First published on April 9, 2015 on Cold Chain IQ – as a contributor,...

The New and Improved ISTA Standard 20 v2

The International Safe Transit Association (ISTA) is a member-driven standards organization. A revised version...

How to Use USP and ASTM to Evaluate Thermal Test Results

To set the stage for this blog post, a thermometer is a device that...

Define Your User Requirements Specifications Upfront to Ensure Success!

Different people have different expectations while developing a drug product shipping solution – for...

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

Note to readers: I wanted to share the following email and reply, since it...

Cold Chain Integrity Challenges Biopharmaceutical Industry

Cold chain integrity is a growing concern in the biopharmaceutical industry. High value cargos...

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

Many of the projects Modality Solutions work on for clients require thermal qualification for...

Three Departments Working Together for Cold Chain Success

How do you go about integrating your cold chain and what is involved? To...

Solid User Requirements Is First Step in Supplier Selection

Did you know there are at least 30 different suppliers of thermal packaging and...

Deviation Torture; Part 2.

Okay, if you’ve read part one of deviation torture, you know the terror of...

Deviation Torture; Part 1

January and August were busy months when I worked in a large pharma company...

User Requirements Specification (URS) Matrix Tool

The beginning of any good engineering project — be it an insulated shipper, designing...

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

The ISTA established a set of standard thermal profiles known as 7E using sound...

Does ISTA 3A Really Simulate Transport?

There were concerns voiced over whether ISTA 3A is working for our industry at...

How old is that trailer?

That’s a question that needs to be known before you load it with temperature...

Trailer Definition

First steps to Trailer Qualification…know what you’re using! It sounds simple, maybe even trite,...

Every Quality Agreement Needs A Great Investigative Reporter

Admit it – We all wanted to be great investigative reporters like Bob Woodward...

Integrate cold chain management systems?

“We integrate cold chain management systems.” I was struggling for a ‘tag line’ for...

Root Cause Analysis for Cell Therapy Primary Packaging Damaged in Transportation

Cold Chain Confidence: A Leading Gene Therapy Company’s Transport Validation Journey

Third-Party Assessment and Verification of Shipment Qualification for a Nationwide Specialty Pharmacy Network

Establishing a Transport Validation Strategy for a Commercial-Ready Biologic Product

Validating Small Molecule Ophthalmics: Transport Expertise Driving NDA Approval

Enabling Ambient Shipping with Stability Data: A Case Study in Global Small Molecule Distribution

Conquering Uncharted Territory: Supply Chain Validation for Cutting-Edge Cell Therapies

Modality Solutions’ Full Cold Chain Transport Validation Package Leads to Successful Filing

Thermal Shipping Strategy and Design to Validate Supply Chain and Save Significant Freight Cost

Standardized Temperature Excursion Reporting Speeds Decision Making and Remediation

Transport Validation Helps Ensure Drug Stability for Ocean Container Shipments

Modeling a Thermal Shipper to Optimize a Global Pharmaceutical Cold Chain

“First Principles” Thermal Modeling Improved Freeze/Thaw Operations

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

Cold Chain Challenges for Combination Device Product

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

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

Transport Simulation, Shipper Qualification, and a Comprehensive Validation Plan Support Multi-Country Filings for a Biotherapeutic Protein

Qualifying frozen, deep-frozen, and cryogenic thermal shippers using a dry ice sublimation rate study.

Advanced Therapies in the Cold Chain

Advanced therapies do not operate within traditional cold chain systems. Temperature control, timelines, and...

First-Cycle Approval in the Biologics and Advanced Therapeutics Guide

Competing in today’s biopharma environment means facing an FDA that no longer plays defense....

Supply Chain Process Validation Guide

Competing priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets are some of...

More Than Just Cold Chain: A Full Spectrum of Supply Chain Success

Ensuring the safe, effective delivery of small molecule drugs is more challenging than ever....

Is Your Cold Chain Keeping You Up At Night?

In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...

How to Select the Right Thermal Packaging for Your Cold Chain

When it comes to ensuring the integrity of temperature-sensitive products during transit, choosing the...

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

Getting your vaccine or therapeutic approved by the FDA is a significant accomplishment. But...

How to Navigate the FDA’s Guidance on Rare Diseases: A Guide for Biopharma Companies

In today’s biopharmaceutical landscape, developing drugs for rare diseases presents unique challenges. The FDA’s...

How to Implement ISTA’s PCG-03 Recommendations

In this guide, the experts at Modality Solutions dive into the considerations listed by...

A Guide to Outsourced Regulatory Expertise for the Biopharma Cold Chain

With this guide, you'll gain valuable insights into best practices for outsourcing the management...

5 Tips for Optimizing Your Clinical Trial Cold Chain in Challenging Regions

Download to discover 5 recommendations for clinical trial optimization in extreme environments.

Our Cold Chain Engineering™ Solutions

Modality Solutions President, Gary Hutchinson, and Principal, Dan Littlefield explain the importance of Cold...

13 Keys for a Successful Monoclonal Antibody BLA Submission

In this guide, the experts from Modality Solutions discuss 13 keys you need to...

Drug Product Formulation Testing with Transport Simulation

Examines the effectiveness of simulated transport studies. This new study uses a holistic form...

A Cold Chain Process Validation Guide

The guide addresses economic and regulatory pressures, accelerating costs, technology changes, and the need...

The Challenges of Cold Chain Validation for Regenerative Medicine

Learn how the cold chain validation landscape for regenerative medicines is rapidly changing.

Simulated Transport Methodologies

Learn how our real-time transport simulation approach is the most reliable way to test...

What You Need to Know About Thermal Shipping Technologies

Examines the performance of five shipping technologies commonly used by specialty pharmacies to transport...

​​Launching in the U.S.: FDA Transport Validation Compliance Essentials for European Manufacturers​ 

Entering the U.S. market comes with a unique set of regulatory challenges, particularly when...

How to Implement Your PQ Strategy

In this video, Engineering Managers Carson Dickey and Rob Battista break down each of...

Applying Heat Transfer Concepts to Evaluate Pre-Qualified Thermal Shippers in the Biopharmaceutical Industry

Heat transfer and thermodynamics concepts can be used to estimate the qualified durations for...

Understanding + Applying Annex 1: New EU GMP

The global regulatory experts at Modality Solutions provide a detailed, tactical approach for meeting...

How to Select the Right Thermal Packaging for Your Cold Chain

How to Respond to Cold Chain Information Requests

Join Modality Solutions Andrew Larrigan, Technical Operations Manager, and Carson Dickey, Senior Consulting Engineer,...

Transport Simulation Testing for Your Therapy: A Better Approach Than Real-World Shipping Tests

Modality Solutions has access to the latest regulatory agency requirements for emerging new therapies....

Cold Chain Validation Best Practices Including Immunotherapy

Join Modality Solutions principals, Gary Hutchinson and Daniel Littlefield, in an informative webinar on...

Modality Solutions Achieves ISO 9001:2015 Recertification, Expands Certification Scope to Greenwood Laboratory

Modality Solutions has successfully achieved recertification to the ISO 9001:2015 standard, reaffirming its commitment...

Modality Solutions, Suttons Creek, CLINTREX, and ToxStrategies—announce their unification under a new brand: BlueRidge Life Sciences

Today, four leading life science companies—Suttons Creek, Modality Solutions, CLINTREX, and ToxStrategies—announce their unification...

Modality Solutions’ New Greenwood Lab Slashes Lead Times and Expands Testing

Modality Solutions is proud to announce the launch of our new Greenwood Lab—a state-of-the-art...

Vertex announces UK approval for CASGEVY™

Congratulations to Vertex for their UK approval for CASGEVY™, a CRISPR/Cas9 gene-edited therapy, for...

Melinta Therapeutics announces FDA approval of REZZAYO™

Congratulations to Melinta Therapeutics for their FDA Approval of REZZAYO™ for the Treatment of...

Iveric Bio announces FDA approval for IZERVAY™️️

Congratulations to Iveric Bio for their FDA approval for IZERVAY™️️, a new treatment for...

Incyte announces FDA approval for Zynyz™

Congratulations to Incyte on their FDA approval for Zynyz™, a treatment for adults with metastatic...

Amicus Therapeutics announces EC approval for Pombiliti™

Congratulations to Amicus Therapeutics for their European Commission approval for Pombiliti™ in patients with Late-Onset...

Acadia Pharmaceuticals, Inc. announces FDA Approval of Daybue

The team at Acadia Pharmaceuticals Inc. announced FDA Approval on their drug Daybue, for...

Atara Biotherapeutics Announces EU Approval

The team at Atara Biotherapeutics announced EU Approval on their allogeneic T-cell therapy to treat adult...

Modality Solutions Welcomes Sumika Stansbury to its Growing Cold Chain Engineering™ Team

September 9, 2021: Modality Solutions announced that Sumika Stansbury has joined the company as...

Modality Solutions Named Inc. 5000 Fastest-Growing Company for Third Year in a Row in 2021

In 2021, Inc. Magazine has again named Modality Solutions to the publication’s annual Inc....

Modality Solutions Adds Matthew Coker to Its Consulting Engineer Team

JULY 20, 2021: Modality Solutions is pleased to announce the addition of Matthew Coker...

Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the...

FDA Grants Priority Review to Agenus’ Balstilimab for Cervical Cancer After Chemotherapy

LEXINGTON, Mass., June 17, 2021 (GLOBE NEWSWIRE) — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology...

Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation

by Brian Gazaille, Gary M. Hutchinson and Daniel J. Littlefield Friday, February 5, 2021...

Safe Transportation of COVID-19 Vaccines: Challenges and Solutions

Gary Hutchinson Daniel J. Littlefield The race for safe, efficacious COVID-19 vaccines is on,...

Modality Solutions Recognized on Inc. Magazine’s List of Fastest-Growing Private Companies in Texas

Modality Solutions, a leading cold chain optimization firm, makes Inc. 5000 Regionals: Texas 2021...

Engineering Angles: Solving the cold chain conundrum

A well-designed transport validation approach can mitigate potential distribution hazards By Gary Hutchinson President,...

Race For a Vaccine: Distributing Vaccines Across America

 Race For a Vaccine: Distributing Vaccines Across America NBC Today Show News –...

Modality Solutions is a Sponsor and Workshop Presenter at the Virtual BMWS20 – Biomanufacturing World Summit

“Our sponsorship and workshop at the BMWS20 support our continued commitment to helping the...

Modality Solutions a Sponsor and Cold Chain Panelist at the Bio Supply Management Alliance (BSMA) 2020 Conference

“As the global biopharmaceutical industry assesses the long-term impact the COVID-19 virus has on...

Modality Solutions Makes 2020 Houston Business Journal Fast 100 List Second Consecutive Year

“Modality Solutions is pleased to be recognized for the second year in a row...

Modality Solutions Makes Inc. 5000 List of America’s Fastest-Growing Companies 2nd Consecutive Year

“Modality Solutions is pleased to be recognized for the second year in a row...

New Simulated Transport Methodologies White Paper Announced

Modality Solutions new white paper details how simulated transport is a valuable technique for...

NBC News Report “The Race to Get a Vaccine Delivered”

Vaccine Delivery – Massive Mission The Race to Get a Vaccine Delivered NBC Nightly...

Modality Solutions Leans into Medical Device Growth Through Engineering

Supply & Demand Chain Executive’s Associate Editor, Brielle Jaekel, included Modality Solutions in her...

Ebola Clinical Trial Liaison Dr. Jean-Jacque Muyembe Honored

Modality Solutions has been actively involved in NIH clinical trials for an Ebola vaccine...

Dan Littlefield Video Interview on DRC Ebola Clinical Trials

Co-founder and principal Dan Littlefield spoke on Modality Solutions’ involvement in the Ebola clinical...

Carson Dickey Joins Engineering Team

Modality Solutions is pleased to announce the addition of Carson Dickey to its growing...

Modality Solutions Announces ISO 9001:2015 Certification

We are pleased to announce we achieved our ISO 9001:2015 registration by certification body...

Modality Solutions Reports 2019 Strongest Year Ever Driven by Awards & Certification

We are pleased to announce our 2019 milestone highlights include recognition by both Inc....

Modality Solutions Included in the 2020 Company Focus & Industry Reference Guide

Modality Solutions was included in the 2020 Company Focus & Industry Reference Guide published...

Modality Solutions In the News: The New York Times

Although Modality Solutions LLC is not mentioned in this New York Times, August 12,...

Modality Solutions In the News: Wall Street Journal

A Wall Street Journal, October 30, 2019 article announced one of the most important...

Modality Solutions Announces Webinar On-Demand Replay

Modality Solutions hosted a live webinar entitled, “Cold Chain Validation Best Practices Including CAR...

Modality Solutions is Silver Sponsor & Workshop Presenter at BMWS19

“Our sponsorship and workshop at the BMWS19 support our continued commitment to helping the...

Modality Solutions Makes Houston Business Journal’s Fast 100 List

“It’s a distinct honor to make the Houston Business Journal’s Fast 100 list,” said...

Modality Solutions Makes Inc. 5000 List of America’s Fastest-Growing Companies

“Modality Solutions is pleased to gain recognition within the American economy’s most dynamic segment—its...

Robert Battista Promoted to Senior Consulting Engineer

Modality Solutions is pleased to announce it has promoted Robert Battista to Senior Consulting...

Rachel Sawyer Joins Engineering Team

Modality Solutions is pleased to announce it has hired Rachel Sawyer as a consulting...

Cold Chain Experts Modality Solutions Recognized as an Inc. Verified Company

Inc. editors independently reviewed Modality Solutions to validate its website functionality and content, social...

Modality Solutions included in Pharmaceutical Outsourcing™ Industry Reference Guide

Modality Solutions was included in the Pharmaceutical Outsourcing™ The Journal of Pharmaceutical & Biopharmaceutical...

Cold Chain Industry Leader, Modality Solutions, is Silver Sponsor and Exhibitor at Biomanufacturing World Summit

Silver Sponsor and exhibitor, Modality Solutions, joins a “who’s who” of pharmaceutical decision makers...

New Cold Chain Process Validation Guide Announced

Modality Solutions new guide helps biopharmaceutical companies meet cold chain regulatory requirements during process...

New Drug Product Formulation Testing White Paper Announced

Modality Solutions new white paper provides a new approach to transport simulation for drug...

Cold Chain Experts Modality Solutions Announce Its New Content-Rich Website Experience

Cold chain experts Modality Solutions is pleased to announce that its new website is...

Media – Cold storage remains the top investment priority in medicine supply

Cold storage remains the top investment priority in medicine supply Pharma Logistics IQ November...

Media – Cold Chain Management Company Launches

Cold Chain Management Company Launches What’s New PharmaVOICE April 2012

Media – Modality Solutions Announces New Advantage Transport Simulation Laboratory

Modality Solutions Announces New Advantage Transport Simulation Laboratory Modality Solutions Pharmaceutical Outsourcing July /...

Media – Biopharmaceutical Industry Discusses Product Transport Validation

Biopharmaceutical Industry Discusses Product Transport Validation Modality Solutions Pharmaceutical Outsourcing July / August 2013

Media – Modality Solutions Addresses Supply Chain Security

Modality Solutions Addresses Supply Chain Security and Interview with Daniel Littlefield Pharmaceutical Outsourcing May...

Media – Filling in the Engineering Gap

Filling in the Engineering Gap Gary Hutchison By Daphne Allen Pharmaceutical and Medical Packaging...

Media – Pharmaceutical Supply Chain: The Next Green Frontier

Pharmaceutical Supply Chain: The Next Green Frontier Written by Gary Hutchinson Life Science Leader...

Media – It’s controlled room temperature time

It’s controlled room temperature time Gary Hutchinson Healthcare Packaging

Media – Mode Shifting Dos, Don’ts and Benefits

Mode Shifting Dos, Don’ts and Benefits Gary Hutchinson By Gail Dutton World Trade WT-100...

Media – Intermodal is Viable – and Growing – for Cold Shipping

Intermodal is Viable – and Growing – for Cold Shipping Gary Hutchinson By Gail...

Media – Thermal Shipping Technologies – Packing Heat?

Thermal Shipping Technologies – Packing Heat? Gary Hutchinson Specialty Pharma Journal.com By: Ron Krawczyk

Media – Logistics Network Launches the Control Room Temperature: Supply, Storage & Strategy Resource Centre

Logistics Network Launches the Control Room Temperature: Supply, Storage & Strategy Resource Centre Gary...

Media – A new way to look at the performance of passive cold-chain shipping containers

A new way to look at the performance of passive cold-chain shipping containers Paul...

Media – Creating Value Through Innovation

Creating Value Through Innovation Gary Hutchison PharmaVOICE The Forum for the Industry Executives April...

Media – Video Interview: Integrating Your Cold-Chain Management Systems

Video Interview: Integrating Your Cold-Chain Management Systems Gary Hutchinson By: SupplyChainBrain July 06, 2012

Media – Webinar: Managing Risk in Your Cold Chain

Webinar: Managing Risk in Your Cold Chain Gary Hutchinson Host: Daphne Allen Pharmaceutical &...

Media – Podcast: Best Practices for Transporting Biologics

Podcast: Best Practices for Transporting Biologics: Gary Hutchinson Hosted By: Shawn Siegel Cold Chain...

Media – Podcast: My Do’s and Don’ts for Integrating Cold Chain Management Systems

Podcast: My Do’s and Don’ts for Integrating Cold Chain Management Systems Gary Hutchinson Hosted...

Modality Solutions Appoints Robert Battista as Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Modality Solutions’ Daniel Littlefield Leads Roundtable at the 17th Annual World Vaccine Congress Wa

Modality Solutions is a sponsor and roundtable leader at the April 10-12, 2017 World...

Modality Solutions Names Gabrielle Mosiniak Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange...

Modality Solutions is a Presenter and Sponsor at 9th Annual BSMA USA Supply Chain Management Forum

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Modality Solutions Announces Partnership with IQPC for the 14th Annual Cold Chain GDP & Temperature

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Cold Chain Management Firm Modality Solutions Names Andrew Larrigan Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

One of Modality Solutions’ Partners, BioConvergence®, Expands Services and Rebrands as Singota™ Solutions

BioConvergence LLC, a life sciences contract service provider, makes a big change to respond...

Cold Chain Management Firm Modality Solutions Names Hannah Anderson Technical Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Shipper Perspectives on the Cold Chain

Modality Solutions’ Gary Hutchinson Joins “Shipper Perspectives on the Cold Chain” Panel at TPM...

Modality Solutions Names Judy Tempel Principal Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

Modality Solutions Gary Hutchinson Named Columnist for Cold Chain IQ

Cold chain subject matter expert, Gary Hutchinson, president of Modality Solutions has been named...

Modality Solutions Names Brian Brazill Consulting Engineer

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly...

enVista Announces Strategic Partnership With Modality Solutions

Alliance brings robust biopharmaceutical cold chain solutions & expansion of enVista’s cold chain capabilities....

Consulting Engineer Brian Brazill to Demonstrate Modality Solutions Advantage Transport Simulation LaboratoryTM Software at the 12th Annual Cold Chain Global Forum

Modality Solutions’ Consulting Engineer Brian Brazill will demonstrate the company’s proprietary transport simulation lab’s...

Modality Solutions and DeltaTrak® Partner to Provide Life Science Cold Chain Monitoring Solution

As approved business partners, Modality Solutions and DeltaTrak® will offer their life science customers...

Modality Solutions Releases New White Paper on Thermal Shipping Technologies

Modality Solutions today released its white paper “The Cold Hard Facts: What You Need...

Brian Wallin Named a 2013 Top Rising Star in Temperature Controlled Logistics

Brian Wallin, a Principal of Modality Solutions, was recognized by Cold Chain IQ as...

LoJack Supply Chain Integrity and Modality Solutions Partner in Cold Chain and Critical Supply Chain

DALLAS, Tex.  March 19, 2013 — LoJack SCI, the leading supplier of supply chain...

Modality Solutions Names Shubhra Kochar Consulting Engineer

Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for...

Sustainability in Biopharmaceutical Thermal Packaging Webcast to Feature Drug-Packaging Experts

Modality Solutions cold chain management experts will discuss packaging and process on June 18,...

Cold Chain Management Experts Launch Modality Solutions, LLC

Five cold chain subject-matter experts launch Modality Solutions, LLC. The privately-held company delivers integrated...

Media – New Media Coverage October 2017

Pharmaceutical Outsourcing™ The Journal of Pharmaceutical & Biopharmaceutical Contract Services — 2018 Company Focus...