Our expert site, LYOFAL, offers an R & D service which can support you in your formulation and process optimisation activities.
FORMULATION DEVELOPMENT AND PROCESS OPTIMISATION
The LYOFAL site proposes a scientific approach for the development of formulations and coordination parameters for freeze-drying cycles. The aim is to obtain a reliable, sturdy cycle on an industrial scale:
Formulation: this requires in-depth knowledge concerning the most effective excipients depending on the product to be freeze-dried (micro-organisms, proteins, peptides, etc.) and the properties required (protection, activity booster, thermal properties, galenic forms, stability, etc.). It also involves a capacity to determine critical temperatures (crystallisation, collapse, vitreous transition, etc.) by cryomicroscopy and differential heat analysis (DSC) for each individual formulation.
Establishment of the freeze-drying cycle on a pilot scale for extrapolation on an industrial scale
- Optimum freezing speed study (supercooling, nucleation, crystallisation, etc.),
- Optimisation of primary and secondary desiccations,
- Design Space approach,
- Areas of 0.5 m² to 3.5 m².
Features of the freeze-dried product
- Measurement of residual humidity using the Karl Fischer method (coulometric analysis ) and water activity,
- Sorption isotherms,
- Vitreous transition temperature according to residual humidity,
- Stability according to temperature and hygrometry
- Functional properties.
Technical advice and expertise on freeze-drying
- Dealing with “non-conformities” (macroscopic appearance, activity, product stability),
- Cycle optimisation (reduction in total duration),
- Advice on equipment coordination.