Cold Chain Validation Best Practices Including Immunotherapy

Sponsored by: Modality Solutions

Focused on:

  • Biopharmaceutical
  • Cold Chain
  • Validation
  • Compliance

Date: 19 September


Time: 4PM London/11AM New York

A Step-by-Step Cold Chain Validation Guide Covering Agency Responses on Latest Class of Therapies

Validating your cold chain to meet and exceed increasingly stringent regulatory expectations in today’s global market is a challenge. With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex. New therapies, accelerating costs, sustainable technologies, and emerging markets demand validated cold chain networks that consistently produce low-cost and high-quality outcomes for patients with a minimal variation delivering value to your supply chain. Build your reputation of reliability with the regulators.

Two of the more exciting immunotherapies, ADCs (Antibody Drug Conjugates) and T-cell therapy (Chimeric Antigen Receptor T cell), have especially complex cold chains. This complexity presents challenges in the tracking, traceability, and storage of the cells a large risk in the treatment process. New validation approaches based on regulatory responses to previously submitted immunotherapy cold chains will be presented in the webinar.

The goal of cold chain process validation is to create a robust operation that ensures qualified product packaging and validated handling, storage, transportation, and distribution operations that are executed according to well-defined, established and proper control and monitoring procedures. Testing for relevant environmental conditions such as temperature, relative humidity, light, shock, and vibration assure product identity, strength, purity, efficacy, quality, and safety. Integrating your stability data on any drug product with your validation strategy will provide protection, especially if your drug product is highly-sensitive to the environmental hazards in the transportation network.

Join industry experts Gary Hutchinson and Dan Littlefield from Modality Solutions in this engaging and informative webinar on how to successfully integrate and validate your biopharmaceutical cold chain. Modality Solutions has access to the latest regulatory agency requirements for emerging new therapies and will share how to successfully validate your combination medical device, monoclonal antibody or immunotherapy cold chain. Register today for the webinar on Cold Chain Validation Best Practices Including Immunotherapy.

Presented by

Gary Hutchinson,


As a founder and the President of Modality Solutions, Gary Hutchinson has developed logistics processes and managed supply chain professional organizations in a variety of industries. Over the last two decades, he has devoted his career to life sciences, becoming a leading authority and expert practitioner of controlled-environment logistics management. He is a leading advocate and sought-after speaker across the industry on cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the supply chain.

Daniel J. Littlefield,

VP, Engineering

Daniel Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions as an innovator in the cold chain logistics industry. Dan recently headed up Modality Solutions' CDC-sponsored Ebola clinical trial operations project in Sierra Leone and NIH-sponsored clinical trial operations project in Liberia in 2015 and 2016. He was a presenter at the 2017 17th Annual World Vaccine Congress and the 2016 PRA Vaccine Summit. Dan is an expert in process improvement, safety, and security for varied industry sectors, including health care, pharmaceutical, packaging, medical device, law enforcement, and defence industries.

Key Learning Objectives

  • Integrate your stability data and testing for environmental hazards during transport of your drug product into a Validation Master Plan for Cold Chain Distribution
  • Qualify your Transport Lanes with Your Operational and Performance Qualification Approach
  • ASTM D4169 is Not Enough: Drug Product Testing for Distribution vs. Packaging Qualification Testing
  • Putting It All Together for the Filing and Inspection: Why Go It Alone?


  • Packaging
  • Packaging Development
  • Supply Chain
  • Program Manager
  • Quality
  • Managing Director
  • Site Head
  • Quality Assurance
  • Technical Manager
  • Technical Operations
  • Transportation
  • Cold Chain
  • Compliance
  • Regulatory Affairs
  • Process Development
  • Clinical Operations
  • Logistics
  • Pharmaceutical Operations
  • Commercial Supply
  • Clinical Supply
  • Scientist
  • Product Quality
  • Stability
  • CMC