UI Pharmaceuticals offers a strong lyophilization cycle development expertise. Let us help you identify appropriate processing parameters for your product.
Clinical Supply Manufacturing

Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

Lyophilization cycle development

Freeze Drying Microscope

UI Pharmaceuticals’ Scientists have extensive experience with lyophilization and lyophilization cycle development. With the installation of a new Lyotherm 2 and Lyostat 2, UIP has significantly enhanced its lyophilization cycle development capabilities.

The Lyotherm 2 provides UIP with an integrated Differential Thermal Analyser (DTA) and electrical impedance (Zsinφ) capability in a single instrument. This allows measurement of glass transition (Tg'), eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying formulations.

The Lyostat 2 is a fully integrated freeze-drying microscope that enables critical events, such as collapse and melting, to be observed in situ, as well as characteristics such as skin or crust formation to be observed and identified.

The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for both formulation and lyophilization cycle development processes. With UIP's in-house expertise, the purchase of this system will allow quicker and more efficient development of lyophilization cycles.

For more information about our lyophilization cycle development capabilities, please Contact Us.