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Approach: |
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The
client supplied Tunnell with the API, targeted product specifications,
and use of their facilities. Tunnell researched the API and competitive
products and generated product development plan for client (plan reviewed
and approved by client). Tunnell project team developed multiple candidate
formulations and determined key product performance criteria. Design
of Experiments (DOE) was used to select lead candidates and arrive
at the final formulation. Tunnell project team identified critical
quality criteria for API, qualified prospective API suppliers, developed
and validated all analytical methods and manufacturing procedures,
established acceptance limits/criteria, scaled-up procedures, optimized
process parameters (incl: particle size and coating), produced trial,
acceptance, and launch lots, developed all project documentation,
and transferred accepted, validated process and controls to the Client.
This was the first time the Client outsourced development of one of
its own products to an external contractor. |
