Raw materials are a fundamental element in the manufacturing of biopharmaceuticals that can impact the performance of the manufacturing process and resulting product quality. To ensure consistent production of high-quality medicines for patients, it is necessary to have a holistic raw material control strategy that includes both scientific and risk-based considerations along with in-depth knowledge of the relationship between raw material attributes and critical to quality attributes. This presentation will focus on two key elements of our raw material control strategy. The first is a novel framework for identifying important material attributes necessary to define fit-for-purpose raw material specifications. The second element is a data analytics initiative for trending raw material performance as a means of monitoring and predicting variation in these important attributes to prevent impact on process performance and product quality. A case study will be presented to highlight how these tools are used to enhance our understanding of the relationship between raw material attributes and product quality attributes to help define well-informed control strategies.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations