The use of these innovative technologies has increased overall process efficiency, productivity, and process robustness. As disposables become widely used in the industry, many CMOs have commented that disposables enable a reduction in GMP-suite turnaround time due to elimination of cleaning requirements, which allows reduction in cost to be passed directly to their customers. The reduced project time line provides flexibility and agility, and CMOs are able to acquire more projects and provide more services.
“For bioreactors, the initial investment cost with disposable systems is substantially lower compared to conventional bioreactors,” explained Prof. Wagner from Rentschler. “In terms of safety, disposable bioreactors greatly reduce the risk of cross-contamination, which is crucial for special applications like cell therapy with human cells for the treatment of cancer and immune system diseases, and production of recombinant biopharmaceutical proteins and vaccines.”
Similar sentiment was echoed by Philip Ridley-Smith, business development and group marketing manager at Cobra, who said, “the design and building of new facilities will benefit from the use of disposable technologies in order to reduce time and cost and provide greater flexibility to the type and range of products that can be manufactured in a single space.
“As more disposable suppliers enter the market and demand increases there should be a decrease in the cost of goods that will reduce the overall production costs. CMOs, and the industry in general, are seeing an increasing trend for the R&D and production of biosimilar products. With these types of products the pressure to reduce the cost of goods is significant and disposable technologies can provide one of the solutions to producing a competitive biosimilar product,” Ridley-Smith concluded.
“Disposables will play an essential role in small-scale GMP environments and in some multiproduct facilities,” Dr. Vucenovic from Boehringer added. “However, stainless steel bioreactors will remain the preferred option for large-volume products.”
According to Dr. Nachtmann from Sandoz, “disposable systems are clearly advantageous for small-scale low-throughput manufacturing enabling high flexibility with lower investment cost. High-throughput development or high-throughput manufacturing at large scale will keep the focus on automated CIP and SIP systems, which are extremely fast, provide reliable quality, and do not need operator interaction.”
However, Dr. Nachtmann also noted that “the setup of disposable systems not only raises general extractables levels, but also needs an installation qualification for each setup. Certainly, disposables can also be implemented in a conventional facility such as capsule filters and bags for transfer small amounts of product.”
While the adoption of disposables reduces cost, it also has an unintended consequence, which is that it lowers the barrier to entry. “The use of disposables is growing as it reduces GMP-suite turnaround times and can help to reduce the cost of goods for a biopharmaceutical product. This is useful for existing manufacturing organizations and their clients. However, what may be key to the CMO industry is that the growing use of disposables also reduces the barriers to entry into this market,” stated Joanne McCudden, Ph.D., director of marketing and sales at SynCo Bio Partners.
“One key barrier has traditionally been the facility set-up costs,” Dr. McCudden explained. “Being able to use disposables in both upstream and downstream production means that the initial capital costs can be reduced. In a competitive marketplace, this poses both a risk and an opportunity to CMOs—CMOs can expand more easily and with lower capital expenditure. However, medium-sized biotech companies, a key market segment to the majority of CMOs, will be able to set up their own facilities more easily too.”
Convenience is a big factor in using disposables in a multipurpose facility, but disposables require great care as noted by Hiroko Tsukamoto, director of marketing at ASPEX, at division of Asahi Glass. “To discard the disposables after use, they need to be cut up and the expenses increase as a result. Therefore, we evaluate the use of disposables on a case-by-case basis.”