The Multi-Attribute Method (MAM) can be used to demonstrate process control and product quality for biotherapeutics such as monoclonal antibodies. However, the data analytical workflow is quite complex, especially considering most software lack the data integrity features to meet 21 CFR Part 11 requirements or may be too complex for most quality control (QC) analysts to utilize efficiently to support batch release in a manufacturing environment.

We will demonstrate how purpose-built software may be used to implement MAM. The guided workflow allows for the execution of system readiness, system suitability, sample acceptance, and critical quality attribute (CQA)monitoring. Additionally, we will show how a novel new peak detection (NPD)algorithm minimizes false positives, which is a long-standing issue in running MAM for manufacturing and QC lot release. We will also demonstrate software technical controls to ensure data integrity and compliance.

Session Speaker:

Melissa Sato, Agilent Technologies, Inc.

Melissa Sato

Appearances