Bioprocessing Single-Use Technologies - A Primer

According to BCC Research, the global single-use technology market will reach over $4.3 billion by 2021. The most significant increase will be in the highly adaptable disposable mixing system segment. Mixing systems are used in every form of biopharmaceutical production as well as through stages of testing. 

The Single-Use Technologies (SUT) Market

The single-use technologies market includes a variety of systems that are used in upstream processing, such as single-use disposable processes:

• Bioreactors
• Bioprocess containers
• Disposable mixers
• Media bags
• Membrane absorbers
• Samplers

Single-use technology is also gaining traction in downstream processing as well. Products like these are now commonly disposable:

• Connectors
• Depth filters
• Disposable filter cartridges
• Tangential flow filters
• Tubing

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Applications of Single-use Technologies in Biopharma

In the biopharma industry, single-use technologies are disposable products which are intended for one-time use. Typically, these disposable products are made of various types of plastic which can be in any of the following forms:

• Polyamide - a synthetic material like nylon
• Polycarbonate - thermoplastic polymers created with carbonate groups
• Polyethylene - a common type of plastic used in clear films and bags
• Polyethersulfone - heat-resistant plastic
• Polypropylene - complex thermoplastic used in both disposable and reusable applications
• Polytetrafluorethylene - synthetic compound of fluoropolymer of tetrafluoroethylene with many uses
• Polyvinyl chloride - typically white, a plastic compound that is resistant to heat and moisture; commonly referred to as PVC
• Cellulose acetate - hard plastic that is made from the acetate ester of cellulose
• Ethylene vinyl acetate - EVA is the copolymer of vinyl acetate and ethylene

Because of the specialized approaches needed to address specific and unique characteristics in bioproduction, SUTs provide solutions that address these needs in the development and manufacturing of biopharmaceuticals.

SUTs Disrupting Biopharma From Testing Through Production

With single-use tech, scientists have the ability to efficaciously manufacture very small amounts of a drug product suitable for testing in both the preclinical and post clinical phases. The increased availability of SUTs in the marketplace has disrupted the biopharma industry. Before the availability of single-use technology, companies were required to purchase and store substantial amounts of raw materials and reusable products. The advent of new single-use technologies allows biopharma to run a much leaner manufacturing process throughout all phases.

For the most part, disposables and SUTs are able to be used in the same manner as their stainless steel counterparts. However, SUT products offer an advantage over reusable systems because they allow more flexibility, improve cost-effectiveness, and decrease time-to-market.

SUT Innovations

Innovative SUTs for large-scale processes like purification and polishing are becoming widely accepted. Also useful are pre-packaged, pre-qualified, and pre-sanitized chromatography columns which contain multiple resins. Some of the most innovative products in this space are:

The Ready To Process Brand by GE Healthcare

This platform has many products designed to help with today's biopharma challenges. The ReadyToProcess WAVE 25 bioreactor single-use system is a reliable cell culture device specifically for volumes in the 0.3 to 25 L range. It has been designed to meet the demands of the regulated environment. This system offers accurate and dependable performance, process control combines with ease of use. The goal of this product line is to simplify and accelerate bioprocessing by reducing time-consuming processes to increase agility in biopharma manufacturing.

Mobius FlexReady Brand from MilliporeSigma

This innovative single-use system offers the ability to build an entire downstream SUT process train or if it better suits your needs, to incorporate individual unit operations for any of the following processes:

• buffer preparation
• media preparation
• chromatography
• clarification
• ultrafiltration or diafiltration

OPUS Columns From Repligen

A complete line of single-use and multiple-use columns that are compatible with other conventional and newer disposable chromatography systems.

Chromabolt

Chromabolt is a line of prepacked columns with specific and custom chromatography resins that are designed for the early clinical stage testing and manufacturing.

CONCLUSION

Expect the single-use technology market to continue to grow, as both processes in upstream and downstream production of pharmaceuticals are increasingly using SUTs in more segments throughout the biotech industry.