HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner

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CASE STUDY

Significantly Improved Productivity of Various Phase 1 Fed-batch Process by Implementing Intensified Fed-batch

HJB intensified fed-batch performance

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Compared to FB, IFB can significantly increase process output while maintaining product comparability. HJB has successfully improved productivity using iFB for several projects. The iFB process has been successfully scaled up to 200L and 2000L in GMP production.


Background

A case of process change from fed-batch to intensified fed-batch (IFB) process demonstrated significantly increase in productivity with maintaining or improving product quality. The primary driver for this change is to boost productivity and accelerate project timeline.


Result

Developed and locked IFB process using our standard platform within 3 months from receiving the cell line.

IFB process increased process output by > 80% when compared to fed-batch, with product quality remained comparable between IFB and FB. The IFB process was successfully scaled up to 2000L in GMP manufacturing. Process changes were approved by regulator.

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CASE STUDY