Blog

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...

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. To...

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

On March 4, 2015, FHI 360 contacted Modality Solutions LLC to inquire about our...

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...

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...

Define Your User Requirements Specifications Upfront to Ensure Success!

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

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...

2012 Annual Meeting AAPS – Chicago

The American Association of Pharmaceutical Scientists (AAPS) conference is four days of meetings and...

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...