Freeze-drying of sterile peptide formulations to improve stability, extend shelf life, and support long-term storage of compounds that are unstable in solution. Lyophilisation is integrated as part of the aseptic fill and finish process, with cycle development, in-process monitoring, and full batch documentation applied to every project according to compound requirements.
Stability
Many peptide-based compounds are chemically or physically unstable in aqueous solution, making lyophilisation a critical step in producing a shelf-stable, clinically viable product. By removing water under controlled vacuum conditions, the process arrests degradation pathways and produces a dry cake that can be reconstituted at the point of use.
Integrating a lyophilisation step is not a decision to be made late in development. Cycle development — including formulation optimisation, primary and secondary drying parameters, and reconstitution validation — requires time and iterative testing. Thanet Labs is building lyophilisation capability as an integrated part of its sterile fill and finish platform, designed to support peptide programmes from early development through to institutional supply.
What We Do
Lyophilisation at Thanet Labs is performed as a downstream step following aseptic filling into sterile vials. Once filled and partially stoppered, vials are transferred directly to the freeze-dryer under controlled conditions, minimising exposure and maintaining sterility throughout. After completion of the drying cycle, vials are fully stoppered, crimped, and passed to visual inspection and batch documentation.
Whether a lyophilisation cycle has been previously developed and is ready for transfer, or cycle development is required from the outset, Thanet Labs can accommodate both pathways. Cycle parameters, product contact materials, and documentation requirements are confirmed at the project scoping stage.
Capabilities
Integration
Performed as part of aseptic fill and finish process
Vial sizes
2 mL – 10 mL sterile glass vials
Environment
ISO 5 laminar airflow / ISO 7 cleanroom surround
Cycle development
Available for new programmes requiring optimisation
Cycle transfer
Supported for established cycles requiring site transfer
Documentation
Full batch records, cycle logs, in-process monitoring data
Reconstitution data
Available on request
Analytical verification
Certificate of analysis issued per batch
Lyophilisation services are subject to applicable MHRA manufacturing authorisation. Supply route, documentation requirements, and intended use confirmed at project scoping stage.
