Maik Jornitz of Sartorius Stedim, Inc. devoted a recent talk at the PDA annual meeting to advances in disposable biopharmaceutical processes. He encouraged the audience to be conscious of the limitations of single-use technologies, but to dream big about their potential as well.
He began his talk by reiterating that, given today’s tough business conditions, single-use technologies are an obvious means of reducing the capital expenses of bioprocess operations. “We’re talking about millions of dollars that go into investments into processes, and maybe single-use technology can help here,” he said.
Another factor that is often overlooked is the potential of disposable technologies to expedite process set-up. “A lot of people forget set-up time, but it can be a big bottleneck in terms of process utilization,” he said. Manufacturers will have different experiences, but more often than not single-use technologies will have much shorter set-up times than stainless steel ones.
Jornitz then turned to a few of the question marks that still surround the use of disposables. What is their environmental impact? Some studies, Jornitz said, have suggested that single-use technologies are more environmentally friendly—e.g., they can reduce carbon usage by 25%—than traditional processes. “This might be an optimistic estimate, or a conservative estimate,” he said. “It’s something that we really need to investigate further.”
What are the limitations of single-use technologies? As titers and production volumes increase, disposable technologies are further challenged. “We must not always think black and white, though,” Jornitz said. Hybrid technologies may be suitable in many instances, and we should “cherry pick” those technologies and solutions that work best for our processes.
Other potential shortcomings of disposables:
- Issues with extractables and leachables: “Do they have an influence on my cell line and overall quality of my product?”
- Scalability (in instances)
- Mechanical strength. “Bioprocess bags have to be handled carefully, for example.”
- Sensor stability. “Sensor technology is one of the greatest unknowns right now.”
- Performance comparability
In these respects, said Jornitz, single-use technologies for bioprocessing are still “the great unknown.” While existing disposable process components such as bags, connectors, and filters are fairly proven technologies, there are still other technologies that are emerging.
Perhaps the most promising of these is the use of disposables for complete unit operations, such as media prep or buffer prep. Will these unit operations at one point be connected to a single process? Maybe, Jornitz said, adding “it’s good to look five to 10 years ahead.”
In addition to unit operations, there is a need for more single-use pumps, valves, filling and other equipment, Jornitz said. What will drive these technologies is the need for improved productivity. “We’re not only talking about cost, but how can I maybe get one more batch out of my facility?” he wondered. “That’s a pretty important business factor.”
Jornitz encouraged the audience to use its vendors to gain from their experience, and allow them to draw from industry’s experience so that they may assist in cost comparisons, and also optimize processes or introduce new process platforms. When the H1N1 pandemic hit, “the industry came to us [vendors] and asked for single-use technology,” he notes. “The main reason was that everything had to be turned around very fast.”
Concluding, Jornitz looked to the future, when disposable technologies have proliferated, hybrid disposable/stainless technologies are readily available, and a 90% disposable process might be possible. “I can also see that we will create microsites using single-use technology to produce, for example, a vaccine at the point of use. That’s just a dream,” he said, “but it’s always good to have a dream.
He left the audience with a quote from Winston Churchill: “A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty.”