Production of clinical trial materials by DPT draws on our experience developing scalable formulations to help clients expedite drug development programs from benchtop to market.
Our formulation scientists and manufacturing teams can work directly with you or your CRO to assist with technology transfers for later phase clinical trial materials, registration batches and commercial launch.
Clinical Trial Materials
- Phase I-III, registration batches and commercial launch
- cGMP batch sizes from 0.3 kg
- Extensive packaging capabilities
Integrated services provided by DPT and in-depth experience with technology transfers ensures clinical trial manufacturing processes and knowledge pass seamlessly to commercial-scale production. Similarly, formulation development expertise and experience moving projects into commercial launch means dosages and processes created early in development scale-up smoothly.
This expertise is consistent regardless of the dosage form. DPT has extensive experience handling the development and cGMP manufacturing of inhaled products, liquids, lotions, and many other dosage forms. Decades of experience working with these projects ensures the clinical trial materials arrive when you need them.
DPT has extensive capabilities in clinical trial manufacturing and can help with identification of packaging options, compatibility assessment, and other related tasks. Also, DPT experts with decades of scale-up experience can provide estimates for when a product begins commercial cGMP manufacturing.
To complete the clinical trial materials service, DPT provides regulatory submission support such as CMC (chemistry, manufacturing and control) preparatory services for IND (investigational new drug) applications. DPT teams involved with preparing regulatory submissions work closely with their colleagues in clinical trial manufacturing to ensure the fast, accurate submission of a detailed CMC filing for the IND. Working with DPT provides the confidence that your project is being handled by experienced industry-leading experts.