Lyophilization Cycle Development

Cycle development begins with understanding the critical temperatures of the formulation by utilizing:

• Modulated Differential Scanning Calorimetry (mDSC)
• Freeze Dry Microscopy (FDM)

Once we have determined the thermal properties of your formulated product, we use the Glass Transition (Tg’), Eutectic Temperature (Te), Collapse Temperature (Tc) and Re-crystallization Temperature (Tcry) data to develop the nominal drying conditions for the lyophilization cycle parameters.
 

To deliver a commercially robust lyophilization process and ensure the finished product consistently meets the finished product CQAs at release, we perform an “Intentional Collapse Study” (ICS) during the final stages of lyophilization development. The Process Development team will perform the ICS study to intentionally collapse the product to fully understand the potential points of failure in the lyophilization cycle.
 

If limited material is available for cycle development, we can develop an experimental plan based on the available API. By establishing the testing plan for development activities, we can use a placebo or small amounts of drug substance in the early stage feasibility before the final confirmatory lyophilization runs.
 

Life cycling the nominal lyophilization cycle parameters, we will specifically optimize the lyophilization cycle for your product, optimizing for low residual moisture, cake appearance, reconstitution, and total run time. Optimizing the cycle for total run time can lead to cost efficiencies over the life-cycle of your product.
 

One important step of your clinical program will be the required toxicology studies. PCI is able to produce toxicology material supplying you with material to support preclinical and your IND submission.
 

If your manufacturing process requires the aid of organic solvents to increase solubility, we can evaluate such solvents as tert-butyl alcohol, acetonitrile, DMSO, or ethanol. We have the experience to safely develop and transfer the manufacturing processes to our GMP manufacturing facilities and work closely with our Environmental Health and Safety (EHS) team to determine the volumes we can safely handle.