Product characterization is the foundation for all formulation and process development. Biopharma Technology uses a range of specific analyses to understand the behaviour of your product throughout the the freeze drying process, and the impact of the different components on it.
Freeze Drying Microscopy is a popular and well-established lyophilization analysis technique. Investigation using the Lyostat freeze drying microscope allows determination of key critical temperatures, such as the eutectic melting temperature (Teu) and collapse temperature (Tc), as well as the identification of crystallization phenomena, skin/crust formation, and the effects of annealing on ice crystal growth and solute structure. Knowledge of the critical temperatures is essential to conduct cycle development on a rational, quantitative scientific basis as well as saving precious resources in terms of time and monies needed.
Differential Thermal Analysis and Impedance Analysis using the unique Lyotherm frozen-state analyzer investigates changes within the frozen product. This provides information such as glass transition (Tg’), eutectic (Teu) and melting (Tm) temperatures. These analyses allow determination of endothermic and exothermic events occurring within the frozen sample, such as crystallizations and eutectic melting, which may have profound implications for the processing and stability of your product.
Moisture Analysis by Karl Fisher Coulometric Titration establishes the amount of moisture remaining in your product after processing (no product is ever truly 100% dry). Moisture analysis is carried out across a batch or several batches to verify that the process is robust enough to tolerate the inevitable variation both within and between batches. This analysis also demonstrates the success and efficiency of the freeze drying process overall.
Modulated Differential Scanning Calorimetry (mDSC) analysis enables glass transitions and other significant events such as crystaliziations to be identified within the freeze dried product. This is necessary to verify that the dried product will retain its structure in storage, resulting in good long-term stability.
Biopharma Group can also provide a range of other analyses including MicroPress which is a quantification method to determine the robustness of lyophilized cake , mechanical testing, SEM, DVS and XRD.
The Benefits of Our Approach
- Thorough product characterization is the foundation for all subsequent development work.
- Any changes in formulation necessary for optimized freeze drying can be easily identified and dealt with early on
- A comprehensive report is provided detailing analyses and results, ideal for quality control and regulatory submissions
- Cytotoxic handling capability in our stand-alone laboratory suite. Read more…