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Development and Qualification of a Robust Cold Chain Logisti
Development and Qualification of a Robust Cold Chain Logisti
Development and Qualification of a Robust Cold Chain Logistics Solution for Protein Drug Products
"Development and Qualification of a Robust Cold Chain Logistics Solution for Bulk Biologics" 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

  • Reference document:
    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

  • Instructor Biography:
    Matthew Olsen, Project Manager, Sartorius Stedim Biotech
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 40.00
    Non Member Price: $ 149.00 / € 110.00

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