The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient
manufacturing capacity, and the economic challenges of producing niche drugs and therapies. Disposable systems can favorably
impact the last item and provide some relief to the others as well.
Disposable systems improve the economic feasibility of producing niche drugs by enabling faster and cost-effective product
changeovers. Manufacturing capacity is gained by simplifying scale up, eliminating process steps, and maximizing throughput.
Because these systems are sterile and remain sterile, positive regulatory reviews are facilitated. Any technology this good
surely deserves a closer look, and that is what follows.
Manufacturing costs generally make up 18% to 20% of a pharmaceutical company's operating costs (1). Maximizing productivity
from manufacturing assets is critical in terms of maintaining a sustainable competitive advantage. This requires fast turnaround
and cleaning procedures, especially when operating multi-product facilities and minimizing shutdown time for modification
and maintenance. Of course, optimizing product recovery presents an additional opportunity to favorably impact costs. We will
show that to maximize overall process efficiency, a holistic approach is needed from the outset, whereby downstream processing
is directly matched with bioreactor performance.
Where Are Disposables Used Today?
A wide range of biopharmaceuticals such as vaccines, monoclonal antibodies, and patient-specific treatments are already being
made with disposable products in certain filtration, purification, and separation applications. Small-scale tangential flow
filters (TFF), direct-flow filters (DFF) of all sizes, and membrane chromatography units are available and adapted for single-use
systems. In addition, capsules can be bundled with bioprocessing bags, tubing, valves or clamps, and connection devices to
form fully- integrated single-use filtration systems. Disposable filters can also be manifolded together to maximize processing
Figure 1. A single-use aseptic connector between flexible tubings requires no laminar flow hood or specialized equipment.
Disposable products are available in a range of sizes, making them ideal for use in every stage of drug development. Single-use
products composed of the same materials of construction minimize re-validation requirements when a new process is scaled up.
The tubing used in these systems is usually clear and the capsule filters are typically designed with clear or translucent
housings. This design feature allows operators to observe fluid levels and flow, as well as to detect fluid discoloration
and air pockets, thereby enabling problems to be identified immediately and isolated from the rest of the process (if required).
Who Stands to Benefit?
High-growth biotechnology companies, large pharmaceutical companies, and contract manufacturers stand to gain significant
speed, safety, and cost-saving benefits by using disposable systems. A disposable processing approach is especially cost-effective
and efficient for start-up biotech companies that do not have hard-piped processing systems already in place. As many biotech
start-ups have not fully defined their operating parameters, single-use products can save them from making premature investments
in capital equipment.
When funding is scarce, single-use products can provide an effective cost- and labor-saving strategy. Additionally, the timeliness
of making a batch for clinical trials can be crucial for the development timeline, and disposable systems can be assembled
much faster that a comparable hard-piped system.
Large pharmaceutical companies have a different motive for incorporating disposable systems into their drug processes. Cost,
capacity, and compliance issues are the deciding factors. The time and labor spent to dismantle, clean, and re-sterilize stainless
steel products is a considerable cost to large pharmaceutical companies. The time required to meet FDA's increasing calls
for documentation of cleaning and cleaning validation procedures can be significantly reduced. Expansion of an existing process
can be more cost-effective and faster if disposable system components are used. A further benefit for pharmaceutical companies
is that it is possible to change an existing filtration process to a disposable process in order to reap the benefits of reduced
cleaning, validation, and assembly requirements. This is a viable option since the same materials of construction are used
for the filters formerly in stainless steel housings. As a result, extensive re-validation is generally not required.
Table 1. Comparison of set-up times between a single-use cartridge filter and a stainless steel housing.
Single-use products help contract manufacturers reduce cross-contamination risks, upfront equipment costs, space requirements,
and complicated cleaning and cleaning validation procedures. This increases profit margin, enhances safety, and reduces compliance
concerns, enabling them to be more competitive in a growing market.
The benefits of disposable processing can be profound. Disposable processing could increase the profitability of niche therapies
and drugs, thereby making treatments for rare or unusual illnesses and diseases more readily available.