Biopharmaceutical Case Studies: Engineering Challenges & Practical Solutions

By Naveenganesh Muralidharan, Sr. Manager, MSAT, AGC Biologics

Biopharmaceutical drugs, or biologics, are complex molecules, including therapeutic proteins, that play a crucial role in treating a wide range of clinical conditions, such as cancers, autoimmune diseases, infections, and genetic disorders. The manufacturing of these biologics through cell culture presents a variety of engineering challenges that are common across the industry, regardless of the type of therapeutic protein being produced.

This eBook focuses on the most frequently encountered challenges and offers practical solutions grounded in scientific concepts and chemical engineering principles. It is designed to help biopharmaceutical manufacturing engineers effectively investigate and troubleshoot complex production issues. Additionally, the use of statistics in biopharmaceutical manufacturing has seen significant growth over the past decade. While other books touch on this subject, this one provides detailed statistical methods with clear, illustrative examples, all worked out using Microsoft Excel.