Concept Life Sciences offers a comprehensive service for pre-formulation and formulation development plus GMP sample production for pre-clinical trial materials. We test and release formulations according to development specifications and produce samples under GMP conditions ready for transfer to study teams.
Our formulation team undertake programs such as maximizing the in-vivo exposure of an NCE for toxicity assessing, formulation de-risking programs, solubility enhancement via excipient screening (using our proprietary solubility screen), developing amorphous solid dispersions, particle size reduction via milling to generate suspensions of nano-sized API in a suitable dosing vehicle (nanosuspension).
We have available a wide range of characterization tools in support of formulation development encompassing parenteral, oral, topical and inhalation products.
Full suite of physical and chemical characterization techniques
Additional solid form optimization services such as polymorph screening/salt screening, micronising or blending to prepare samples for further development can be undertaken in house; these services are also supported by a full suite of physical and chemical characterization techniques.
Additional API processing services such as micronising or blending to prepare samples for further development can be undertaken and we carry out such work on site with characterization analysis.
- Freeze Drier (SCANVAC 110-U PRO)
- Food Pharma Systems Pilot Mill 2 microniser
- Heidolph Titramax 1000 shaking heating incubator
- Homogeniser (IKA T25D)
- Multi inlet vortex mixer (4 port custom design)
- Combined impinging jets mixer (custom design)
- Turbula Blender T2F
- Spex 8000M-230 Ball mill
- Fritsch Pulverisette 5 Nano mill with small volume adapter
Pre-formulation / Pre-nomination / Formulation
- Screens: Salt / Polymorph / Crystallisation / Co-crystal
- Extensive API characterization, including NMR and single crystal XRD
- Solubility in aqueous, organic, biorelevant media
- Absolute solubility
- pKa, LogP/D outputs, Drug absorption modeling
- Multi-gram scale-up
- Enabling formulations, Solubility enhancement, Controlled release
- Tablets, capsules, liquids, suspensions, pulmonary (pMDI / DPI)
- Particle size reduction including micronisation and nano-milling (g to kg)
- Lyophilisation (g to kg)
- Evaporation (e.g. Rotary Evaporation to 10L)
- Generation of amorphous material (e.g. HME and spray drying)
- Powder blending and release for tox trials
Bioanalysis and biomarkers
Cleaning validation and verification
Clinical and commercial manufacturing
Contaminants and foreign bodies
GXP analytical method development, validation and transfer
Out of specification investigations
Process research and development and pre-clinical API manufacture
QC release and GMP release testing
Storage stability studies