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.

ASTM/ISTA

Solid User Requirements Is First Step in Supplier Selection

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Solid User Requirements Is First Step in Supplier Selection

Deviation Torture; Part 2.

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Deviation Torture; Part 2.

Deviation Torture; Part 1

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Deviation Torture; Part 1

User Requirements Specification (URS) Matrix Tool

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

User Requirements Specification (URS) Matrix Tool

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...

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

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

Does ISTA 3A Really Simulate Transport?

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Does ISTA 3A Really Simulate Transport?

Trailer Definition

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

ASTM/ISTA Biologic Cell & Gene Cold Chain Engineering Drug-Device Combo Products Emerging BioPharma Pharmaceutical Public Health CROs Service Providers

Trailer Definition