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. Click Here For Complete Article Text
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