Single-Use Technologies—A Contract Biomanufacturer's Perspective - Disposable technology presents an attractive opportunity for CMOs to cut down production costs. - BioPharm International

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Single-Use Technologies—A Contract Biomanufacturer's Perspective
Disposable technology presents an attractive opportunity for CMOs to cut down production costs.


BioPharm International Supplements


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.



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.


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