If you were to liken the interest in single-use and disposable technologies in the pharmaceutical industry to terms we are familiar with when talking about hot web topics, you might say they have been “trending” for several years, or perhaps they have gone “viral” – but that might have some negative connotations in the industry, after all the industry is trying to eliminate viruses not promote them.
Or, if you want to harken back to an older (though still in use) metric for gauging what’s popular, you might say that single use and disposable technologies have been in the Top 40 for a long time – or maybe even the Top 10. But I digress.
Single-use and disposable technologies have been in use in the biopharm industry for quite some time now. And while their acceptance as a viable substitute for more traditional processing equipment continues to grow – there is still some hesitance in the industry to adopt single-use entirely for many processes. Innovator biopharm companies are picking places in their processing facilities where they feel single-use technologies can be most beneficial. For biopharm CMOs the choice to go to single-use has been a much easier one – with consideration of lower cost, less cleaning and the elimination of cross-contamination worries among the most important reasons to adopt single-use technologies.
In order to get a better idea of what is going on inside the word of single-use technologies and what the latest thinking and trends are, we talked to several single-use/disposable equipment vendors to get their insights.
What’s Trending Now
To get a sense of where the current single-use market place is at – we asked our vendors what they have seen regarding recent trends and developments for this technology.
According to Dominic M. Clarke, Ph.D., Global Product Manager, Cell Therapy & Bioprocessing, Charter Medical, Ltd., technology bundling is a recent development, “We are seeing the bundling between single-use disposable bag technologies and sensor technologies to provide solutions to the end-users.”
The Freeze-Pak™ STS disposable frozen storage solution. Photo courtesy: Charter Medical
The use of single-use technologies in downstream processing is also gaining in prominence as Steven Cates, V.P. Engineering, ALPHABIO, Inc. explains, “We are noticing a greater adoption of single-use for downstream technologies (e.g. harvest steps, clarification, purification, etc.) due to significant improvements in process control techniques (e.g. SU automated encapsulated process valving, SU process instrumentation, etc.), which also leads to a reduction in cost/batch for the SU components.”
The push to bigger sizes for single-use equipment is being noticed by Ken Davis, Global Product Line Manager, Value Plastics, “We are seeing customers migrate towards large sizes confirming the trend towards larger scaled up production capabilities.”
Cates concurs with Davis’ observation noting, ”We are definitely seeing an upswing in the request for larger scale SU process systems.”
And while Clarke at Charter Medical doesn’t see an upswing in the use of single-use technologies for larger batches he mentions there is a practical limit to their size. “I don’t know the limit per se but there is definitely a limit imposed by the manual handling required from the operators. With single-use bags reaching sizes of 3500L and greater now, the technology can handle the larger size requirements of the industry. Handling them certainly is a challenge, but solutions to handle this will likely be resolved with time.” Speaking to the practical limits of single-use technology, Cates offers his views, “We believe that 2" ID line sizes should be the "practical" limit for SU process systems. This "belief" is based upon the current materials typically used for SU tubing sets and the fact that the shear bulk weight of these large tubing sets create handling difficulties during change outs as well as limitations with current packing techniques."
Single Use Versus Stainless Steel
The transition from processing systems mainly constructed from stainless steel materials to one composed of single-use/disposable equipment has been a process that has been going on for some time. We asked our equipment vendors to talk about this transition.
“I don’ think we will see a complete replacement,” says Charter’s Clarke, “but more and more hybrid solutions are giving the pharmaceutical industry more flexibility.”
Regarding the replacement of stainless steel with single-use Cates doesn’t think it will be a complete replacement, “Larger scale processes as well as some of the support utilities (e.g. RO/DI/WFI water generation, Clean Steam, etc.) will continue to require stainless steel components."
“It (replacing stainless steel with disposables) is taking place now. There are 100 percent single-use facilities on line now,” says Davis.
Push Versus Pull
Developing new technology and tools for manufacturing biopharmaceuticals can be tricky. Sometimes the manufacturers are ahead of the curve and sometimes the vendors are – and sometimes they even work together.
“This is joint effort,” says Davis. “Originally it was being pushed just by the vendors but now end-users are joining groups like BPSA and BPE support the shift towards single-use.”
Single-use clamps connect tubing to filters. Photo courtesy: Value Plastics
Cates offers his view on this dynamic, “We feel that this is being driven from both sides. Vendors who want to provide novel as well as increasing sales, of course, and industry who are looking for improved process efficiency with greater product efficacy (yield) with cost/batch savings to justify the new process.”
“Definitely the industry!” says Clarke. “The vendors have limited resources and even the large marketing driven companies are listening to their customer needs to develop new products.”
Single-use technologies are here to stay. As time progresses and materials and equipment become proven and accepted the use of the product is sure to grow. As far as what the short term outlook is for these technologies in the industry our experts offer their opinions.
"I see a continued adoption for small to medium sized biopharm and CMO manufacturing facilities with equipment changeover costs as well as re-validation costs being the major limiting factor for the larger manufacturing facilities,” says Cates.
“I see more integration to provide complete solutions in the upstream part of the process,” says Clarke. “Additionally, the success of cellular therapy is dependent on single-use.”