Pre-clinical formulation

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 programmes such as maximising the in-vivo exposure of a NCE for toxicity assessing, formulation de-risking programmes, 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 characterisation tools in support of formulation development encompassing parenteral, oral, topical and inhalation products.

Full suite of physical and chemical characterisation techniques

Additional solid form optimisation 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 characterisation 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 characterisation analysis.

  • Equipment

    • 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 characterisation, including NMR and single crystal XRD
    • Solubility in aqueous, organic, biorelevant media
    • Absolute solubility
    • pKa, LogP/D outputs, Drug absorption modelling
    • Multi-gram scale-up
    • Enabling formulations, Solubility enhancement, Controlled release
    • Tablets, capsules, liquids, suspensions, pulmonary (pMDI / DPI)
  • Processing

    • 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

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GMP stability

Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release. Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

API release

Concept Life Sciences' specialist release test laboratory offers a unique blend of high-end materials characterisation techniques (e.g. XRPD, PSD) combined with standard chromatographic (including LC, GC, TLC, IC) and elemental / compendial techniques (such as ICP, LoD, Karl Fischer) to meet niche requirements.

Clinical API manufacture

Concept Life Sciences delivers reliable, cost effective and timely supply of intermediates and APIs. Our technical and quality expertise makes us a leading strategic manufacturing partner. Concept can produce 1 to 10kg batches of API to GMP standards from our API manufacturing suite, located at our research and development facility.