cGMP Manufacturing Case Studies

Expert Solutions to these Challenging Scenarios

Challenge:

 

Client required clinical supplies for a dose escalation study using softgel capsules.  The client was not comfortable with the traditional dose escalation strategy of preparing multiple dose forms up front.  The goal was flexible manufacture that avoided multiple capsule dosing.

 

Velesco Solution:

 

  • Velesco offers hand filling of softgel capsules for small scale clinical studies.
  • Velesco was able to formulate the drug over a wide range of concentrations and to prepare cohort-specific dose strengths, permitting single capsule dosing.
  • By using this strategy, along with dose bracketing, the stability program was shortened and bulk drug use was greatly reduced over traditional manufacture.

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