- United Kingdom
- Human Medicines, Biopharmaceuticals
- Service category
- Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, …
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Our expertise can be applied at any stage of a freeze-drying project from research and development through to cGMP production. We offer a range of services and analytical techniques related to freeze-drying.
Formulation Optimisation/Excipient Selection
Designing the formulation and selecting the appropriate excipients is a crucial stage in developing any product for manufacture. Lyosolutions Limited has developed formulations and process cycles for virtually every type of pharmaceutical and bioproduct commercially available, including pharmaceuticals, proteins, vaccines and live cells.
Freeze-Drying Cycle Development
Cycle optimisation is a particular specialisation of ours. Each product requires an individually designed cycle. Development trials by Lyosolutions Limited have resulted in considerable cost savings to industry. Such savings can only be achieved by an in-depth practical understanding of the freeze-drying process combined with a comprehensive analysis of the product using the analytical techniques provided by us.
A variety of techniques are used to analyse products, both pre and post freeze-drying. Data from these analyses are used to aid cycle design in the first instance and then help assess the suitability of the cycle.
- Freeze-drying Microscopy – Identifies the collapse temperature of the product.
- Karl Fischer Titration – Measures moisture content of freeze-dried material.
- Differential Scanning Calorimetry – Thermal analysis to identify glass transition temperatures
- SDS PAGE – Allows analysis of peptide integrity/aggregation.
- Spectrophotometry – Allows quantification of peptides or nucleic acids
Design Space Determination
The design space of a freeze-drying cycle provides a range of parameters within which a suitable output can be obtained. This provides flexibility in the freeze-drying cycle, facilitating the transition to production scale freeze dryers. Lyosolutions Limited has experience in defining the design space for freeze-drying cycles, tailoring the work to fit any product or budget.
Transfer to cGMP production
Problems often arise during the transition from pilot scale freeze-dryers to manufacture scale machines. With our experience and expertise, we can minimise these issues and liaise with the CMO to make this transition as smooth as possible.
Consultancy and Technical Training
We provide a consultancy service for all aspects of freeze-drying, whether or not we developed a cycle for your product. In addition, we offer technical training courses and overviews in freeze-drying. Our courses can be held on-site or centrally and can be tailored from our extensive list of topics either as a basic introduction to the technology or a more in-depth course, such as process optimisation or validation, designed for specialist applications.
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