Single-use mixing provides an agile & adaptable solution when bringing drug product formulation steps in-house, as the trend towards higher titer, smaller batches continues. Higher viscosities associated with subcutaneous formulations challenge the envisioned design space for systems intended for gentle protein mixing. To mitigate the risk to the process of suboptimal mixing, this study evaluated the mixer design space through blending studies with surrogate solutions and with CFD modeling. Implementation of these techniques helps to transform drug product development and tech transfer strategies.

Adapting single-use mixing solutions for high titer drug product formulation: A case study

253rd National Meeting (2017)

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