Lyophilization: Custom freeze drying.

Catachem Inc., has a long history in the technology of lyophilization having developed its expertise in the early 2000s when it produced freeze dried sera for the VLA Quality Assurance program. This program involved shipping an identical freeze-dried product to over 100 laboratories across the globe. This required extreme accuracy in the manufacturing process.

Since that time Catachem has increased its lyophilization capacity to handle larger customer volumes and has upgraded its equipment to handle many different types of lyophilization including lyophilization for research use only (RUO) reagents.

Catachem can produce large or small batches of freeze-dried product in stoppered vials sealed under vacuum or under nitrogen if a product is affected by oxygen exposure. We can lyophilize product in 2ML to 100ML vials and anything in between. We can also produce large trays of freeze-dried material in bulk.

Freeze drying is generally regarded as the most reliable method of producing a dry stable product. This is particularly important for proteins. Most proteins are relatively unstable in a liquid format. By gently eliminating the water that they are dissolved in during the freeze drying process, the protein retains its configuration and is restored to full activity once reconstituted.

Different products require different freeze-drying “recipes”. These recipes are based on the type of product being freeze-dried, the volume involved, the bulking materials involved and the crystalline “cake” that is preferred.

A recipe consists of the freeze dry temperature, time and various ramp up temperatures to gently heat the product to drive off the water. Some materials need the recipe to include a system of temperature cycling to make better freeze-dried crystals.

Catachem has the experience to examine a product to be lyophilized and calculate how best to write the recipe to ensure that the product is successfully freeze-dried.