
Contract Lyophilisation (Freeze Drying)
Lyophilisation is a process in which liquid material is slowly frozen in a vacuum, thereby removing water by maintaining the water vapour pressure. This technology appears to be very simple, but when the techniques are practiced and developed, the processes are deceptively complex.
Lyophilisation consists of three separate unique and interdependent processes—freezing, primary drying (sublimation) and secondary drying (desorption).
Lyophilisation is a key practice within the pharmaceutical, biotechnology and food industries as it is necessary for the effective long term storage and stability of biologics and other sensitive materials. Optimisation of freezing and drying times; ideal buffer selection; pH fluctuations, and excipient choice can all complicate the lyophilisation process.
Process Development/Optimisation
Bovogen Biologicals is able to offer process development and optimisation lyophilisation services through the utilisation of a 60 litre ice capacity pilot lyophiliser. This process includes:
- Optimisation of freezing cycles
- Optimisation of drying cycles
- Selection of appropriate stabiliser and/or excipients
The data gathered from pilot trials can then be used to develop appropriate large scale drying cycles.
Bulk Product Lyophilisation
The company has one of the largest capacity lyophilisers used for bioprocessing in Australia or New Zealand providing Bovogen Biologicals with a unique processing capability.
A fully validated, 1000 litre ice capacity lyophiliser is PLC controlled to provide optimal drying and consistency between batch cycles. Specific drying cycles for a variety of products can be developed to specification and/or customer requirements.
Finished product processing and/or packaging can also be provided on request.
freeze drying services brochure - download
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