Abstract
The implementation of single-use systems—which can deliver significant value through added flexibility, improved production
yields, and cost savings—is gaining momentum in the biopharmaceutical manufacturing industry. The initial single-use systems
that gained market acceptance consisted of tubing, bags, filters, and connectors. Today, additional types of disposable technologies
are being used throughout the production cycle. This article discusses how single-use transfer lines can be incorporated into
seed train and final fill applications as well as suite-to-suite transfer operations.
Colder Products Company
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Manufacturers across industries rely on innovative technology to meet two critical production requirements, speed and cost-efficiency.
With the increasing pressure to reduce time to market and costs, biopharmaceutical manufacturers are exploring new technologies
to meet these challenges.
With the costs to manufacture a single drug approaching $1 billion and time-to-market ranging from eight to 12 years, biopharmaceutical
manufacturers are under tremendous pressure to commercialize new drugs faster at a lower cost.
To meet these intense market demands, manufacturers are being forced to continuously boost manufacturing speed and efficiency
by relying on innovative technology that can be easily integrated into their existing production processes. One solution that
continues to gain momentum is single-use systems, which can deliver significant value through added flexibility, improved
production yields, and significant cost savings.
The initial single-use systems that gained market acceptance consisted of tubing, bags, filters, and connectors. These systems
were used in bioprocessing facilities for process storage applications and sterile cell culture media. Single-use bioreactors
then entered the market in research and development laboratories and rapidly moved into pilot plants and larger-scale production
facilities as integral systems for seed train scale-up and production.
Now, single-use transfer lines are emerging as yet another option for manufacturers to save time and cost. Unlike hard piping,
the flexible tubing incorporated into single-use transfer lines allows manufacturers to quickly change process steps or convert
to a new product without costly and time-consuming cleaning and validation. This is a key advantage for multiple-product facilities
in which process requirements change depending on the drug being produced. Innovative manufacturers now incorporate single-use
transfer lines in seed train and final fill applications as well as suite-to-suite transfer operations.
The Benefits
The key benefit of single-use transfer lines is the ability to boost productivity and accelerate the time to market by reducing
the downtime associated with equipment cleaning and validation. Between each production batch, fixed tubing and re-usable
valves must be cleaned to maintain desired sterility. Single-use systems are presterilized and eliminate the need for traditional
cleaning and sterilization. This reduced downtime translates into greater productivity and throughput. Instead of the entire
process being placed on hold for validation, a single-use system can allow the process to be up and running sooner, thereby
increasing output and accelerating the time to market.
Additional cost savings result from reduced labor, chemical, water, and energy demands associated with cleaning and validation.
Not only do single-use systems reduce costs, they also improve the safety of drug development and delivery. Presterilized,
single-use assemblies reduce the risk of cross contamination that may lead to product loss or reduced yields. This benefit
is further magnified for companies that produce multiple products within single facilities.
Seed Trains
Figure 1.
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Modern bioprocessing facilities feature production bioreactors with capacities of 5,000, 10,000 and even 25,000 liters. Scaling
up inoculum from a few million cells in several milliliters of culture to these production volumes is a challenge that requires
aseptic transfer at each point along the seed train. Traditional bioprocessing facilities accomplish scale-up using a dedicated
series of stainless steel bioreactors linked together with valves and rigid tubing (Figure 1).
