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.
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.
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.