With the historical success of blockbuster products, the biopharmaceutical industry has required large manufacturing capacity with single-product facilities built to produce large volumes of a single blockbuster drug. More recently, however, with the changing business and regulatory environment, facilities have to be more flexible and capable of producing multiple products. They need to have shorter production campaigns, facilitate faster changeovers, and concurrently manufacture different products to meet the more diversified pipeline demand of small volume productions.
Furthermore, balancing capacity and efficiency across an organization’s manufacturing network, as well as producing clinical and commercial batches in the same facility for faster time to market, has introduced additional dimensions of flexibility. Therefore many single-product facilities have been converted to multiproduct use, and innovative companies have been leading the charge on flexibility.
As the industry transitions toward multiproduct and multipurpose manufacturing facilities, one major challenge lies in how to change the facilities built for a specific product. For discussion purposes, the following generalities about the manufacturing facilities can be made.
- Drug substance – trending away from single-product facilities
- Commercial facilities – one to six products per year, increasing with a shift to include clinical products (i.e., products meant for clinical trials)
- Stand-alone clinical facilities – five to 12 products per year, not including multiple variants or processes for some products
- Process development – 10 to 15 products per year, comprised of technical development and production support/investigation runs per product
- Fill finish (drug product) – typically multiproduct, but may have dedicated lines depending on final delivery medium or other factors
Manufacturing automation implications
Multiproduct facilities require flexible automation. Flexibility is measured in many ways and applies to all aspects of the automation system, including the batch software design and physical architecture. Ultimately, the measure of flexibility is cost of change. Higher cost of change is driven by increased complexity. Complex changes have higher resource demand, require more time, and inherently bring increased risk to existing operations. Therefore, a less flexible automation is less adaptable to multiple products.
Harmik Begi, director of information systems at Amgen, has more than 22 years of experience in the biopharmaceutical and food/beverage industries.
Gregory Bischoff, principal IS automation engineer at Amgen, has 20 years of automation experience and is responsible for delivering the automation work stream for large-scale capital projects in a corporate role.
Josh Gangl, operations IS platform lead at Amgen, has more than 15 years of process engineering, process automation, and manufacturing information systems experience.