The Lyophilization Process
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 robustness and functionality
This is where experience is needed. Formulation and process are indelibly linked and cannot be separated. Formulation alters the design process, but process impacts the material characteristics, which can then feed back to alter the behavior of the formulation.
Unfortunately, companies begin to suffer a mechanical effect as they attempt to build out their lyophilization capabilities
With non-ideal equipment purchased, poorly characterized materials, and a lower base of knowledge, there is inconsistency in batches of lyophilized products. Attempting to correct the deviations, companies experience an on going but rather fruitless chain-reaction of establishing, revising, then revising again and again, new protocols and processes.
The Reason For Specialization
Argonaut decided that rather than providing basic lyophilization processes, it would invest not only in top-notch equipment but also experience. The depth of knowledge required could only be developed over time, so Argonaut acquired LyoGen, which has been providing lyophilization services for over 17 years. Tightly integrating the lyophilization process with an entire manufacturing and kitting line creates a streamlined feedback loop resulting in faster development time and more robust processes.
When faced with the same decision as other companies, rather than deploying a generic lyophilization solution, Argonaut decided to specialize in lyophilization. Now you can leverage Argonauts:
- Specialized equipment
- Years of experience
- Critical resources (including ISO clean rooms)
These are the key components needed for a successful lyophilization process and are ready to be deployed to your product.
To learn more about our lyophilization capabilities, call us at 888-834-8892 or visit our website at www.argonautms.com