Infinity’s GMP laboratories employ state-of-the-art techniques and instrumentation.

Before method development begins, we define the analytical method objectives, including the critical quality attribute(s) to be measured, applicable reference standards, and the method’s intended use.

Given Infinity’s extensive drug and medical product analytical experience, we can often draw on previous experience with validation of similar products. Infinity also has the expertise to develop robust methods for novel drug substances or medical device materials.

Analytical methods are then optimized and evaluated throughout all phases of product development to ensure that they remain consistent with established goals.

The established analytical method must be validated to ensure it meets the required performance characteristics. The specific characteristics evaluated during the method validation process include:

A validated method may need to be transferred in from, or out to, another qualified laboratory. When this is the case, we apply highly efficient procedures to quickly get each new sites up to speed on the validated methods. Infinity also swiftly and efficiently transfers qualified methods into different labs across our national network of laboratories.