Abstract
The closed and controlled environment of single-use technologies in a biopharmaceutical production process can significantly
reduce processing time. A fully disposable option eliminates cross contamination, cleaning, and subsequent validation, reducing
the use of water for injection. Lower operating costs, smaller equipment footprints, increased productivity, and rapid turnaround
time are some of the major benefits that are driving the market demand for single-use technology in manufacturing. This article
discusses a contract manufacturing organization's perspective on the use of disposable technology in the biopharmaceutical
production process.
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To eliminate contamination and to comply with the FDA cleaning regulations, manufacturers spend a lot of money, time, and
resources on equipment cleaning and sterilization—steps that require large volumes of water for injection (WFI)—and cleaning
validation. Most bioprocess equipment is made of stainless steel and requires assembly, clean in place (CIP), and steam-in-place
(SIP), all of which result in manufacturing downtime. By using disposables, contract manufacturing organizations (CMOs) can
save WFI costs by not having to clean the stainless steel bioreactors and validate the cleaning process every time.
These reasons have fostered the advent of single-use technology, which has been embraced by technologically inclined companies.
These companies understand that significant investment capital is needed to construct a manufacturing facility. It costs $10
million to construct, equip, and launch a 100-L traditional pilot plant facility. The cost goes up to $40 million for a 1,000-L
pilot plant and for a 10,000-to 20,000-L facility, the cost becomes prohibitive, and may be as high as several hundred million
dollars.1,2
Because of their customizable design, disposables facilitate faster design, construction, and commissioning of facilities
and offer manufacturing flexibility—a significant operational benefit. Reduced processing time, enhanced productivity, smaller
and flexible production facility, and reduced operating costs are some of the major benefits that are driving the market demand
for single-use technology.
Financial Considerations
Contract biomanufacturing companies are continually striving to improve and optimize the process of manufacturing biotherapeutics
at every stage, starting from preclinical toxicology material to large-scale current good manufacturing practice (cGMP) commercial
production. A contract manufacturer on average makes a 33% profit in manufacturing a biotherapeutic.3 In order to be competitive and be commercially viable, CMOs have to make improvements in this area. They have a pressing
need to economize the manufacturing process, skillfully manage their project pipeline, and help their sponsors accelerate
their speed to clinic or market.
Process economics is not for just the dedicated CMOs, however. A biopharmaceutical company with inbuilt capacity is in a similar
situation, spending more than 20–25% of its operational cost on manufacturing,4 and is equally interested in lowering the production costs. Disposable technology presents an attractive opportunity to
cut down production costs for both biopharmaceutical and contract manufacturers.
Where Are Disposables Used in a Biomanufacturing Process?
Single-use filters, single-use tangential-flow filtration (TFF) membranes, flexible tubing, sterile liquid containment bags,
disposable bioreactors, mixing systems for media preparation, sterile bags with normal-flow filter manifolds, and aseptic
connectors are all used in appropriate steps during the process. These disposables optimize processes and accelerate biomanufacturing
production time. In downstream processing, disposable formats are used for cell removal, harvest clarification, membrane absorption
chromatography steps, viral filtration, ultra filtration, and diafiltration. At Laureate, we use single-use technology at
all of these steps throughout the biomanufacturing process.
Cell Culture
For small-scale culture scale-up, we routinely use disposable flasks and roller bottles. For larger scales up to 1,000 L,
we use disposable Wave cell bags.
