Drug product manufacturing
Scale-up and tech transfer
Supporting a smooth transition from development to clinical supply
Transfer from R&D to clinical phase I and II at Xedev
At Xedev, no or only limited process transfer is required when moving from R&D batches to clinical Phase I or II batches, as we operate the same equipment in both our R&D and GMP laboratories. This integrated approach ensures a smooth and reliable transition from development to clinical supply.
Transfer to your facility or to an external manufacturing partner
When your process needs to be transferred – whether to your own facility or to an external manufacturing partner – with a structured and stepwise approach, Xedev ensures a smooth transition with strong risk mitigation.
Critical Process Parameters and Quality Attributes
We identify the critical process parameters (CPPs) and define the critical quality attributes (CQAs) of your product, providing a comprehensive understanding of both process and product.
Process Design Space (DoE)
Using Design of Experiments (DoE), we map the process behavior to define the process design space, understand process robustness and variability, and determine optimal operating ranges.
With a clearly defined process window and a thorough risk assessment, your product is ready for a robust and reliable transfer to the selected technology or equipment.
Scale-up spray dry capabilities
We also offer larger-scale spray dry capabilities on the SD1L spray dryer, developed by our sister company Procept. With a 5-6 times larger capacity than a 4M8-TriX spray dryer, the SD1L spray dryer enables efficient scale-up from smaller batches to larger quantities while maintaining product quality. Its fully modular design allows multiple drying columns to operate in parallel, further increasing capacity and flexibility to meet your production needs.
Ready to develop your powders, granules, tablets, capsules, inhalables and injectables for clinical testing?
Discover how we prepare your formulation for clinical manufacturing.