A: UNFORTUNATELY, NO CHANGE in the highly regulated bioprocess industry is “simple;” and it requires appropriate risk assessment. Still, if you could make changes with a lower post-approval change scrutiny, the first one I would make would be to go from stainless steel to single-use process technologies. The reasons for such range from reduced set-up times — and therefore higher manufacturing capacity utilization — to reduced cleaning/steaming needs which equal energy cost savings. Also, the footprint of these facilities is smaller, and fewer personnel are needed, which all contribute to a lower cost of goods. Pioneering sites like Amgen’s Singapore site will accelerate a shift in the industry to more agile, multiproduct, and multipurpose processes.
Maik is COO of G-CON Manufacturing and founder of BioProcess Resources. He has more than 25 years of experience.