Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
A lack of single-use technologies
The greatest barrier for adoption of single-use technology for downstream applications has been a lack of adequate technology, particularly in the sensor area, that provides for a robust automation approach, according to Pora. “Not all downstream process steps are available in single use,” agrees Ullah. For those technologies that are available, she adds, scalability, performance, and cost are typical limitations.
Chromatography is the last purification unit operation to move to disposability and has seen only limited use, according to Gebski. She notes that the adoption of pre-packed, limited-use chromatography in the industry has been particularly slow, even though the value proposition for early clinical phase manufacturing is clear (time savings, where time can be spent on more value-added activities). “It is possible that customers do not perceive column packing as a pinch point (non-value-add point) in their manufacturing process (i.e., the problem is not big enough) or perceive a decrease in flexibility with respect to defining the required column geometries,” she suggests.
From the larger perspective, Masser points out that the conversion of the traditional batch manufacturing processes currently used for downstream manufacturing to more continuous approaches requires the development of revolutionary technologies, such as continuous chromatography systems. On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have historically been concerns regarding the evaluation of plastics in terms of extractables and leachables. “These concerns have, however, been successfully addressed by single-use suppliers through validation studies,” he stresses.
Drivers for adoption
The success that biopharmaceutical manufacturers have had with single-use technologies for upstream applications is providing significant impetus for their application to downstream operations. “Validation studies have proven that single-use technologies work, and as a result, companies are more inclined to trust them,” Pora comments. In addition, she notes that the industry is changing and requires more flexibility than any traditional set up can offer. “Single-use technologies are, quite simply, more agile and can be implemented much more quickly; the flexibility they offer is certainly a key factor behind the growing willingness of people to give them a try.”
Furthermore, according to Masser, the continued integration and extensive use of plastics in upstream manufacturing has meant that the evaluation and study of plastics has been extensive as well, and the comfort level achieved with upstream systems is now being transferred to downstream applications. “The level of bioburden reduction and elimination that single-use technology provides is another huge motivator for its adoption in downstream processing,” he says.
About the Author
Cynthia A. Challener is contributing editor for BioPharm International.