Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today
they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration,
clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other
therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming
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
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, firstname.lastname@example.org