Development and Qualification of a Robust Cold Chain Logistics Solution for Protein Drug Products

This online course contains everything you wanted to know about handling of frozen bulk and API. From defining the best solution according to the key requirements, to testing validation according to the standard guidances.

The rapid expansion of biopharmaceutical production has triggered the need for robust, scaleable and reproducible preservation and transportation methods at the manufacturing-scale. Freezing and thawing operations are key steps, intended to stabilize the protein drugs before fill and finish, during storage and/or transportation. However, those critical operations, albeit widely employed in the biotechnology industries, are generating lively debates regarding safety issues. This session will focus on the development of a robust cold chain logistic for cGMP applications and its validation under rigorous conditions.

  • Overview of freezing containers and review of the cold-chain distribution network
  • Definition of the cGMP based industry practice for development and design qualification of thermal packaging
  • Definition and Overview of the testing strategy Final designs and validation results

ISPE Good Practice Guide: Cold Chain Management

Available for purchase 9 May 2011 . The industry needs specific guidance on how to attain consistency in the transport of the products requiring specific parameters to maintain safety, efficacy and quality of the medicinal product during transportation from the manufacturer to the consumer. Areas to be covered include: equipment, regulatory requirements, qualification of packaging, and anti-counterfeiting systems. Goal is to provide practical guidance in the area of cold chain management, with examples of typical documents. At the conclusion of this session, participants will be able to:

  • Understand the importance of a cold chain logistic and the impact on product stability
  • Understand how to set up a validation of thermal and transportation packaging
  • Be confident with the adoption of freezing methods, as a successful key process for product preservation and transportation
Placeholder Person Graphic
Matthew M. Olsen
Field Marketing Manager
Sartorius Stedim Biotech


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