Demand for CMO fermentation capacity has exploded in the past couple of years, and it’s become very important that we find new ways to meet industry demand. That’s a big reason we’re seeing single-use fermentation (SUF) technology as an accelerating trend in the industry, especially for us at Aldevron.
Moving away from stainless
When I started in clinical-grade manufacturing, like so many companies in the sector we used stainless steel fermenters for production. That limited our throughput due to the requirement for clean in place/steam in place (CIP/SIP) cycles where we would physically clean and sterilize all the equipment before each production run. That was a weak link in the process, as there are significant time and cost investments to go through cleaning validations correctly to ensure there is no cross-contamination between runs. In addition, the need for CIP/SIP reduced facility throughput and capacity.
Now, with the advent of single-use technologies, we have bags or films we use in most of our production processes, which reduces down time and cost. Rather than have resources tied up during cleaning and verification, we throw away the bag and begin production on a new product in just a few hours.
Since we’ve seen significant increase in demand over years, we’re constantly evolving to meet that demand and single-use fermentation (SUF) is just one tool we’ve implemented. We are using larger fermentation units and building a new facility with increased capacity.
Switching makes sense
What does the switch to SUF mean for clients and the research they do? First off, I mentioned that the technology allows for us to add capacity to meet growing demand. We can scale our system up to 300L with what is in place, and scaling to 1000L would be a matter of adding more equipment and rearranging manufacturing spaces. These activities can be done relatively quickly as compared to what timelines would be if we were dealing with stainless steel with its CIP/SIP approach and additional support structures.
Another important aspect is that SUF eliminates concerns with cross-contamination. Couple that with accelerated timelines as we no longer have a need for cleaning validation, and you can see why this change is exciting for us, and for the industry at large.
Overall, the switch to SUF technology is one that provides maximum flexibility for us and timely product generation for clients. It’s an important step in improving quality and quantity, important factors for our clients' and our continued success.