At the forefront of the nanomedicine landscape.
This fast-evolving field uses nanoscale or nanostructured materials to impart unique pharmacokinetic and therapeutic effects such as enhanced dissolution rate and oral bioavailability, targeted delivery, enhanced efficacy and reduced toxicity.
The control of materials in the nanometer size range requires scientifically demanding chemistry, analysis and manufacturing techniques. Our nanomedicine expertise encompasses formulation, process and analytical development, GMP manufacturing and dossier development.
We are experts in the following formulations:
- Crystalline nanosuspensions
- Polymeric micelles and polymeric nanoparticles
- PLGA micro- and nanospheres
- Super paramagnetic iron oxide nanoparticles (SPIONs)
- Silica nanoparticles
Once we identify a suitable formulation, our scientists develop phase-appropriate production processes in accordance with cGMP and mitigate technology transfer issues by using the same teams for development and manufacturing.
- Wet milling
- Spray drying
- Fluid bed coating
- Continuous flow processing
- High-temperature processing
- Tangential-flow filtration
- Magnetic separation
- Single-use systems
In our cGMP-compliant manufacturing facilities, we can produce volumes of a couple of millilitres to multiple litres, using batch-type and continuous-flow processes. We also work with highly-potent drug substances and can deliver nanosuspensions and nanoparticle solutions as sterile finished drug products in vials or syringes.
To support product development and to perform quality control of GMP-produced drug products, we utilise state-of-the-art analytical techniques such as:
- Nuclear magnetic resonance, infrared and Raman spectroscopy
- Dynamic light scattering, small-angle X-ray scattering, laser diffraction and size-exclusion chromatography
- Zeta-potential measurements
- Transmission and scanning electron microscopy
- Advanced dissolution techniques
Dossier development and strategic regulatory support
Having advanced a wide range of nanomedicine formulations into the clinic, we are used to developing new manufacturing techniques and analytical procedures under fierce regulatory scrutiny. Our understanding of the regulatory landscape gives your nanomedicine project the greatest chance of approval.