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Lyophilization Process- The Argument for Specialization - Argonaut Manufacturing
Lyophilization is the process of preservation by freezing the product, lowering the pressure, and removing the ice by sublimation. The lyophilization process has tremendous advantages in pharmaceuticals and reagent kitting, and is becoming a foundational technology. As can be expected, companies use different strategies to access lyophilization processing technology. The Challenges With Generalization Building lyophilization capabilities in house requires relatively straightforward purchasing of expensive equipment, building a low humidity facility, and sending staff to classes. This is often where companies start. However, that is only the tip of the iceberg, as companies also need to select the proper excipients, cryoprotectants, and bulking agents to stabilize the active reagents. The collapse and glass transition temperature for the formulation must then be determined. This is accomplished by purchasing specialized equipment (e.g. differential scanning calorimeter (DSC)). Based on the key material properties, the lyophilization parameters can be determined and process analytics established and monitored. Unfortunately, because companies reverse the process, rather than starting with characterizing the materials, they can end up with a lyophilizer that doesn’t meet their needs. Not only does this waste money, it can consume a tremendous amount of time. A second challenge with in-house lyophilization is that even if the lyophilization process is successful, the robustness of the process may not be apparent. Without established statistical process control (SPC) to evaluate product limits and bounds, the lyophilization process may unknowingly be on a knife-edge. Slight deviations or variances in input characteristics can definitely impact the product quality including product …