Listicle: Evaluating & Optimizing Critical Quality Attributes During Cell Line Development

Overview

Biopharmaceuticals, such as vaccines, recombinant proteins and gene therapy products are currently used to treat a broad range of diseases. These therapeutics are mostly produced using living cells in culture therefore, the development of stable and robust cell lines is at the core of efficient biopharmaceutical production as it determines productivity and product quality.

CQAs are defined by regulatory agencies as the physical, chemical, biological or microbiological characteristics that must fall within an appropriate range to ensure the desired product quality. Identifying and measuring critical quality attributes (CQAs) early in the cell line development (CLD) process is of crucial importance to ensure the product’s clinical safety and efficacy. Failure to adequately measure CQAs during the CLD process may lead to drug attrition during late-stage clinical trials or safety concerns after the product is on the market.

This listicle outlines what CQAs should be measured and when, as well tips and solutions for optimizing measurements.

• Document type: Article
• Page count: 6
• Read time: 8 minutes

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