Title: Choosing a Cleanroom Infrastructure Technology

Consider a matrix of factors when choosing what type of cleanroom facility to construct. The bio/pharmaceutical industry is experiencing a paradigm shift—not only for therapies, but for the entire support infrastructure. The process streams and surrounding cleanroom and facility infrastructures for recombinant proteins are drastically different from those for small-molecule processes. Advances in cell and gene therapies and continuous bioprocessing require a shift as well. In these cases, the scale of the processes can range from small, per-patient batches to multiple, 2000-L fluid volume streams. These different applications require in-depth review so that that the best processing and cleanroom infrastructure platform may be chosen. Decisions can no longer be based on a single parameter, such as initial cost. Rather, a matrix of different factors must be evaluated. This article addresses the different decision points behind this approach, to guide determination of the best cleanroom and technology choice.

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Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Infrastructure





  • Pharmaceutical Technology


  • 1/2/2021


  • Article