04.05.24 -- Process Development: Stuck In The Middle With You

Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.

What is tabletability and why is it important for creating tablets that can survive the journey from manufacturing to packaging?

ASDs improve bioavailability to provide acceptable in vivo performance, but production requires an enabling technology. Spray drying and hot melt extrusion are among the most widely applied.

With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the production process.

KinetiSol is a fusion-based, solvent-free process that utilizes frictional and shear energies in a fraction of the time of other amorphous solid dispersion technologies.

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.