Product Characterization Services

Product characterization is the foundation for all formulation and process development. BTL use a range of specific analyses to understand the behavior of your product throughout the different stages of the freeze drying process, and the impact of the different components within it.

Our Analyses

Freeze Drying Microscopy is a popular and well-established lyophilization analysis technique. Investigation using BTL’s own Lyostatinstrument 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 BTL’s Lyotherminstrument 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.

Modulated Differential Scanning Calorimetry MDSC analysis enables the final freeze dried product to be analyzed and any glass transitions to be identified. This is necessary to verify that the dried product will retain its structure in storage, resulting in good long term stability and good rates of activity.

Moisture Analysis by Karl Fisher Coulometric Titration and Frequency Modulated Spectroscopy 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.

The Benefits of BTL’s 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