Biosimilar Process Change Comparability

INTRODUCTION

Process Change is the key element of life cycle of biologic product development. Biopharmaceutical manufacturers especially Biosimilars manufacturers frequently make changes to the manufacturing processes of products both during product development and after approval. Biologic drugs are highly complex molecules produced by living cells and The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary during the manufacturing process change hence, it is expected that multiple changes in the manufacturing process could impact drug product quality, safety, and efficacy.

A comparability exercise generally needs to perform that products have highly similar quality attributes before and after manufacturing process changes and that no adverse impact on the safety or efficacy, including immunogenicity, of the drug product occurred. This conclusion can be based on an analysis of product quality attributes. In some cases, nonclinical or clinical data might contribute to the conclusion.

“WHY” PROCESS CHANGE

There could be many reasons a manufacturer considered manufacturing process change. These might include but is not limited to;

1. Improving Manufacturing Process Step

2. Changing Manufacturing Site

3. Increasing Manufacturing Scale

4. Improving Product Stability

5. Changing Equipment Type

6. Complying with changes in regulatory requirements

GOAL POST OF PROCESS CHANGES