Topic #2: Challenges of Multi-Product Facilities

Multi-product facilities are becoming more common in the biopharmaceutical industry.  The development of therapies guided by personalized medicine is driving a shift from blockbuster drugs to niche busters.  As a result, facilities must be increasingly flexible, enabling rapid changeovers and supporting smaller batch sizes.  As companies cope with the challenges of multi-product facilities, what chromatography technologies are at the forefront?

Our experts describe what chromatography technologies are especially suited to helping companies cope with the challenges of multi-product facilities.

What we need to deal with multi-product facilities is a suite of products that minimize the possibility of cross contamination and speed changeover between products.  There are two opposite approaches: a fully disposable processing train or a processing train that can be completely cleaned in place.

A fully disposable train can be enabled with prepacked…

Here at Boehringer Ingelheim, our two production facilities and clinical supply plant are multi-product facilities.  New generation antibodies and antibody fragments that require 100-fold lower concentration to treat patients present unique challenges.  We have to ensure that changeover times are very short and processes are highly flexible.  The packing time for columns and reassembly of filters…