Drug manufacturers face constant pressure to speed processing and reduce the time to market for new therapies — while ensuring quality. Disposable processing is attractive as a means to eliminate cleaning and cleaning validation. Complicated cleaning procedures can be difficult to document, and it is even harder to prove that traces of cleaning chemicals have been removed. Rather than proving the effectiveness of cleaning, a disposable unit can simply be discarded after one use.
Disposable products are available in a range of sizes for use at every stage from drug discovery to production. Single-use products using the same construction materials minimize re-validation requirements as a new process is scaled up.TRANSITION TO BUNDLED SOLUTIONS A growing trend in biopharmaceutical manufacturing is the use of single-use systems as bundled solutions such as disposable bags, capsule filters, tubing, clamps, adaptors, and connection devices. These systems are often supplied pre-sterilized (by gamma irradiation) and pre-assembled, thus eliminating the need for sterilization and sterilization validation procedures and reducing costs associated with sterilization equipment. The disposable-product supplier provides validation guides, instructions for use, and information to allow users to perform performance qualification. While the cost of sterilization by gamma irradiation is comparable to that of traditional steam sterilization methods, it reduces labor and eliminates problems associated with in-house steam sterilization.
Bundled solutions can be taken out of the box and placed onto the manufacturing floor; they can be used alone or as part of an integrated system. In addition to eliminating cleaning and cleaning validation, integrated single-use systems remove set-up and steam-sterilization steps and reduce the potential for cross-contamination and operator exposure to hazardous biological materials. Furthermore, companies avoid the huge capital investment of stainless steel systems.
DISPOSABLES AND MODERN MANUFACTURING The increasing use of single-use systems highlights an overall change in how manufacturing takes place. Traditional drug production entails designing and building a manufacturing facility dedicated to a single product. Today such a model would be fiscally challenging, particularly for biotech start-ups.
Modern manufacturing requires multi-mode plant design that enables fast change-overs, production of multiple products, and minimal shutdown for modification and maintenance. Disposable systems fit well with this modular, flexible manufacturing paradigm.
Disposable systems are also well-suited to start-up companies with limited processing needs and for operations where parameters frequently change. They can be designed and installed faster than hard-piped stainless steel systems. This improves the manufacturing economics for niche drugs by enabling faster, more cost-effective product changeovers.
Overall, disposable systems increase manufacturing capacity by simplifying scale-up, eliminating process steps, minimizing validation time, facilitating FDA reviews, maximizing throughput, and speeding product changeovers. This helps manufacturers produce more drugs in less time and respond nimbly to a dynamic marketplace.
Ian Sellick is director of marketing for biopharmaceuticals, Pall Corporation, 2200 Northern Boulevard, East Hills, NY 11548-1289, 800.717.7255, fax 516.801.9548, [email protected]