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The new ICH M12 guideline on drug interaction studies provides a harmonized approach expected to be implemented by the major regulatory authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and presumably replace their respective existing guidance.

Explore the differences between the 2020 FDA Guidance and the 2024 ICH M12 Guideline with our handy reference document.

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Download our presentation from Recovery of Biological Products XX titled “Turning the crank using a hybrid continuous purification platform” from Michelle Najera, Megan McClure, Shahbaz Gardezi and Beth Larimore.

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Process intensification solutions for monoclonal antibodies, Fc-fusion proteins and bispecific antibodies t ease liquid handling pain points.
Our J.CHO^TM High Expression System is delivering perfusion permeate titers of over 2 g/L/d over 25 days.
Continuous capture chromatography significantly enhances resin utilization
Two tank virus inactivation steps can be developed with bench-scale models

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Watch our webinar by expert Rob Elsby on assessing transporter risk during drug discovery and development.

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