Pre-formulation, Formulation & Process Development, GMP Manufacture
We specialise in developing your clinical candidates into safe and effective formulations and manufacture oral dose products for clinical trials.
Our integrated model ensures seamless transitions between development and GMP manufacturing. This reduces risks, shortens timelines and simplifies project management.
Pre-formulation
- Full drug substance physiochemical characterisation
- Polymorph, salt and co-crystal screening
- Detailed solubility enhancing polymer and excipient screening
Equipment:
- Buchi S300
Formulation & Process Development
- Review excipient compatibility
- Develop advanced formulation
- Develop Spray Drying or Melt Extrusion Process
- Liquid Fill – Develop lipid-based (solid & semi-solid) formulations.
Equipment:
- Buchi S300 & GEA PSD 1
GMP Manufacture
At Almac, we provide flexible, high quality GMP manufacturing solutions tailored for clinical trials. With dedicated GMP suites and our full suite of analytical support, we ensure every batch meets rigorous quality standards, accelerating product timelines and simplifying project management.