Multiple Products in a Monoclonal Antibody S88.01 Batch Plant

Overview:

The most successful biotech companies have multiple products approved for market and must make the use of existing manufacturing capacity to produce them. Often times this requires rapid changeover from one product to the next. This paper addresses the challenges with bringing new products into an existing S88.01 facility and the challenges involved in maintaining the standard as well as implementing a change in an operating plant with a minimum of downtime. It was found that the S88 concept is enormously helpful in implementing changes within the equipment capability but that challenges arise when the equipment capability must be changed also. The recommendation is to standardize the manufacturing process and build the necessary capability into the plant upfront to avoid costly downtime during product changeover.

There's More to This Story
Get more. You can read the rest of this story and other exclusive content as a Control Global community member. It's FREE, and it’s easy. We just need your name and email address. Then you can read everything you want on our site and even comment on it.

Author: Mahasti Kheradmand, John O’Connell, WBF

Find more white papers on Batch Management

View all white papers»