Case Study

The Method Detectives: Building A New Business Model With Analytical Procedure (Method) Lifecycle Management

Source: Waters, Inc.
Gears workflow process management

Chromicent GmbH is a pharmaceutical service provider offering services in all stages of the analytical method lifecycle. Founded in 2013, the company specializes in the development of analytical methods using an analytical quality-by-design (AQbD) approach under the umbrella of the new Analytical Procedure Lifecycle Management, (also known as Method Lifecycle Management or MLCM) initiative that is gaining traction in the industry. In addition, method validation, analytical instrument qualification (AIQ), laboratory efficiency improvement, and Good Manufacturing Practice (GMP) compliance services are available from Chromicent.

MLCM combines activities of analytical method development, improvement, qualification, validation, transfer, and maintenance related to GMP production. As part of its approach, Chromicent uses AQbD as an early risk assessment to clearly identify method parameters that have an impact on analytical performance, as well as risks associated with variability such as sample preparation, instrument configuration, and environmental conditions.

Read how Waters instrumentation and software is helping Chromicent in troubleshooting methods because it is highly robust, dependable, and reproducible, even for the most demanding separations.

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