A biotech approached Upperton with a formulation developed externally by another CDMO. The biotech wanted to accelerate clinical supply manufacturing for an upcoming trial. During the initial technical transfer, our team identified critical formulation deficiencies. 

Taking the time to reformulate would have put the future of the project at risk. Therefore, the challenge was to address the critical formulation deficiencies without extending the timeline of the project. 

As a result, Upperton conducted rapid batch manufacturing to assess formulation robustness and identify key deficiencies. Upon identification, we saw that these could be mitigated through processing parameter adjustments. 

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