How much does lyophilization cost?

The power costs depend on your region, but freeze driers consume an average of 990-1500 watts per hour, which will amount to an average of $1.25 to $3 a day. However, the total running cost depends on how often you use your machine and the size of the dryer.

What is lyophilization in pharmaceutical industry?

Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.

What is protein lyophilization?

Lyophilization involves freezing a protein solution followed by removal of ice by sublimation. The process subjects the protein to stresses such as denaturation at the ice surface, pH shifts and freeze concentration (Anchordoquy & Carpenter, 1996; Bhatnagar, Bogner, & Pikal, 2007; Chang, Kendrick, & Carpenter, 1996b).

What is the difference between lyophilization and freezing?

Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product, lowering pressure, then removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.

Why is Freeze-drying expensive?

However, most of the currently available freeze dryers require longer drying time, which leads to high energy consumption and high capital cost. This is partly due to the poor heat transfer rate as the sublimation front moves from the exterior to the interior of the frozen material being dried.

Why is lyophilization needed?

“If the bulk drug ingredients are not stable in liquid or frozen form, lyophilization is necessary. This can be due to chemical reactions, degradation, aggregation, biological growth, heat sensitivity, etc.

How do you Lyophilize protein?

The process involves the removal of bulk water from a frozen protein solution by sublimation under vacuum with gentle heating (primary drying). This is followed by controlled heating to more elevated temperatures for removal of the remaining “bound” water from the protein preparation (secondary drying).

What are the disadvantages of lyophilization?

Removing water without having to heat the product excessively. Dissolution of reconstituted product (rapidly and easily)…The FDA also lists some of the disadvantages of lyophilization:

  • Handling and processing time increases.
  • Sterile diluent needed upon reconstitution.
  • Equipment becomes costly and complex.

Why are protein drugs lyophilized instead of being kept in liquid form?

Some of the advantages of lyophilization, according to the FDA, include: Processing a liquid with ease (and thereby simplifying aseptic handling) Enhancing the stability of a dry powder as well as the product stability in a dry state. Removing water without having to heat the product excessively.