At this year’s 2015 Annual ISPE Meeting, there has been a number of engaging discussions on a variety of important facets of the industry: single-use technology and its implementation, aseptic technologies, compliance, data integrity, drug shortages, and more.
One particular presentation, titled “Lessons Learned from Implementing Single-use Technology in Biomanufacturing from Clinical to Commercial Scale,” was set up similar to a town hall meeting. In this setting, professionals and experts were encouraged to ask questions and talk about their experience regarding single-use technologies.
Stepping into this particular session, I had thought the conversations would gear towards the specific (and varied) applications of single-use technology. From my experiences thus far in our industry, there have been countless discussions about the ease of application and use of these technologies—particularly when compared to traditional methods. You can image that I was pleasantly surprised as experts dove into both the positive side as well as the “dark side” of single-use technologies.
The Advantages of Single-Use Technologies
Jeff Odum, Director of Operations at IPS-Integrated, listed some of the reasons for this shift to single-use technologies. These reasons include:
- Flexibility
- Improved utilization
- Decreased manufacturing footprint
- Speed
- Reduced operational costs
- Reduced validation costs
- Rapid product development
- Adaptability
- Reduced facility costs
- Reduced cost of goods
- Fewer FTEs
- Easier transfer/move process
- No cleaning validation
- Low capital investment
- Decreased process times
Lesley Wood, Head of Engineering at Lonza AG, voiced one benefit of single-use technologies. As a CMO, Lonza has to be mindful of what she called “change-overs” between clients. These change-over periods can be very costly if the time is long in between the production of one drug and the next. Therefore, the upside of disposables, according to Wood, is that it makes the change-over time faster.
Wood also divulged, in response to a question from the audience, that single-use technologies are much more prominent among smaller companies. These smaller companies cannot afford the huge stainless steel machines, and therefore choose to utilize single-use technologies. However, she did point out that these companies aren’t typically working in clinical.
Yet, even with these apparent advantages, there is always the flip side.
The Disadvantages of Single-Use Technologies
Don Powers, Principle Scientist at Janssen Cell Therapy, explained that single-use technologies can get costly—despite their notoriety for being affordable. If a company wants a customized disposable of some kind, the price is quick to rise. Powers recommends that companies get ownership of any custom drawings or designs of these disposables. This way, companies can go to backup vendors with their design, if necessary (compared to having the vendor creating these customized disposable having full rights to the custom design). For now, companies are working towards standardizing single-use bags, which may eventually help to alleviate the high costs of customization.
In addition, Powers explained that the upfront cost for stainless steel machines is more than single-use machines. However, if a company already has stainless steel machines set up in their facility, it is much more costly to then set up single-use machinery than to proceed with the stainless steel machines.
Other concerns regarding single-use technologies include:
- Difficulty in efficiently producing in bulk
- Having to rely on vendors
- Higher consumables cost
- Inventory storage
- Lot/material tracking
- Vendor-initiated change controls
- Limited number of gamma irradiation facilities
Wood explained the difficulty pertaining to inventory storage in more detail. She said that many companies are forced to stock up on single-use technologies because they are afraid that they will run out of materials. As a result, companies find themselves uncertain where to store this 9-month inventory (or more) and how to most efficiently move these products around their facilities.
Overall, there was a theme of encouragement with regards to being hands-on with your single-use vendors. Experts recommend companies do audits to know how disposables are made. This is because regulatory groups are expecting companies to know the process as they check things such as single-use bags. Particularly, companies need to know how leachables and extractables affect their product.
As more CMOs move toward single-use technology, selecting vendors (and forming partnerships) will become critical.
