Method Development, Validation & Regulatory Support

Infinity provides comprehensive analytical solutions to support our partners at each stage of their therapeutic or medical device’s developmental journey. We maintain a network of cGMP analytical research laboratories across the country and employ state-of-the-art techniques and instrumentation, including:

Proper method development involves establishing a set of specific experimental conditions under which we perform analytical procedures for your chemical samples. Infinity optimizes this process through our cGMP facilities and our staff’s deep expertise in a wide variety of therapeutic and medical device focus areas.

Before method development begins, our team defines 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 often draw on previous experience validating 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 consistency with established goals.

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

The method transfer process is a routine analytical research laboratory exercise in which our team demonstrates and documents that a method developed in another laboratory can be successfully reproduced in our laboratories. This step is crucial when conducting research for your pharmaceutical or medical device product in multiple facilities and helps ensure that further tests will provide accurate and repeatable results.

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 site up to speed on the validated methods. Infinity also swiftly and efficiently transfers qualified methods into different labs across our national network of laboratories.