CryoVault™ Single-Use, End-to-End, Freeze and Thaw Platform for Bulk Drug Substance: A Client Case Study

CryoVault™ Single-Use, End-to-End, Freeze and Thaw Platform for Bulk Drug Substance: A Client Case Study

07/16/2020, 4:15 PM - 5:00 PM

Innovation Stage, Booth 1281, Exhibit Hall
Language:
English
This session will feature a presentation on AstraZeneca's case study, which encompasses the successful implementation of a novel, innovative single-use platform (CryoVault™) for the freeze and thaw of bulk drug substance. This case study will focus on production of their monoclonal antibodies (mAb), and all aspects of the end to end freeze and thaw platform, including the fill, freeze, distribution, thaw mix, and final dispense of drug product. Adoption of this technology included a paradigm shift (i.e. out of traditional biocontainer assemblies limited to <16 L capacity, into completely single-use containers that allow up to a 100 L capacity).

Contributors

  • Max Blomberg

    Speaker

    Executive Director of Operations

    Meissner Filtration Products

Objective

  1. Objective 1. Provide an update on the currently available methods to freeze and thaw Bulk Drug Substance (BDS), and discuss industry challenges from an end-user's perspective (e.g. Maintenance, Expense, Logistics, Robustness, Volume Limitations, Uncontrolled Freeze/Thaw Rates). 2. Explain the importance behind the principle of the Last Point of Freezing (LFP) and its significance in the role of controlled freeze/thaw rates to maintain quality of bulk drug substance. 3. Provide a contemporary example of a successful, novel freeze and thaw solution implementation that addresses needs of both drug substance and drug product sites, harmoniously, even though they may be at disparate locations.

Type of Session

  1. Type of Session
    Case Study

Categories

  1. Track
    Processing/Manufacturing

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