Understanding Single-Use Technology in Bioprocessing

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Understanding Single-Use Technology in Bioprocessing

Reading Time: 6 minutes
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Pharmaceutical manufacturing involves the production of drugs and medications on a large scale. Various types of equipment are used throughout the manufacturing process to ensure quality, safety, and efficiency. This equipment ranges from stainless steel systems designed for harsh cleaning regimens to modern solutions employing single-use technologies.

In this blog, we’ll explore how single-use technologies have revolutionized the biopharmaceutical industry, review challenges like regulatory compliance and environmental concerns, and examine prospects in the evolving landscape of patient-centric bioprocessing.

Understanding Single-Use Systems

Single-use technologies are products or solutions designed to be used only once and then disposed of. They are typically made from plastic materials, such as polyethylene, polypropylene, polycarbonate, and polyvinyl chloride. Some common components of single-use systems are bags, tubing, connectors, filters, sensors, bioreactors, mixers, chromatography columns, and filling needles. These components can be assembled into various configurations to perform different unit operations, such as cell culture, harvest, purification, formulation, and filling.

The evolution and adoption of single-use technologies in the biopharmaceutical industry have been driven by the increasing demand for biologics, especially monoclonal antibodies and vaccines. Single-use technologies enable faster development and production of these complex molecules, which require high quality and safety standards. They also facilitate the implementation of modular and flexible facilities, which can be easily adapted to changing market needs and regulatory requirements.

Single-use technologies have become a mature and widely accepted option for biopharmaceutical manufacturing. The global single-use bioreactors market was valued at US$21.98 billion in 2021 and is expected to grow at a compounded rate of 16.1% into 2030.

Advantages of Single-Use Technology

Single-use technologies offer many advantages for biopharmaceutical production, such as reducing the risk of contamination, increasing flexibility and scalability, saving time and costs, and minimizing environmental impact.

Two main benefits of single-use technologies are their cost-effectiveness and reduced capital investment. Compared to traditional stainless-steel systems, single-use systems have lower upfront costs, as they do not require expensive installation, validation, and maintenance. They also have lower operating costs and consume less energy, water, and chemicals. Furthermore, single-use systems can reduce the risk of product loss due to contamination or equipment failure, which can significantly impact the profitability of biopharmaceutical production.

Another advantage of single-use technologies is their minimization of cross-contamination risks. Since single-use components are pre-sterilized and disposed of after use, eliminating the need for cleaning and sterilization between batches. This reduces the potential for microbial or chemical contamination, which can compromise the quality and safety of biopharmaceutical products. Moreover, single-use systems can prevent cross-contamination between products or processes, which is especially important for multi-product facilities or contract manufacturing organizations.

Single-use technologies also offer increased flexibility and quicker turnaround times. Single-use systems can be easily configured and reconfigured to meet the specific needs of different products or processes. They can also be scaled up or down to match the demand and capacity of biopharmaceutical production. Additionally, single-use systems can shorten the time required for changeover, validation, and start-up, as they do not involve complex cleaning and sterilization procedures. This enables faster development and delivery of biopharmaceutical products to the market.

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Applications of Single-Use Technologies

Single-use technologies are rapidly transforming the bioprocessing industry, with applications in all stages of the manufacturing process, from upstream to downstream, from fill-finish to quality control and analytics.

Upstream

Upstream bioprocessing involves everything from preparing media to growing and producing cells or microbes in a bioreactor. Many single-use systems are available for upstream processes. Disposable mixers mix and store cell culture media and other reagents. Single-use bioreactors are vessels that contain a disposable bag or chamber where cells are grown under controlled conditions. The continued investment of biopharmaceuticals in new manufacturing facilities has also been a critical factor as facilities are designed from the bottom up to use single-use technologies, so-called “single-use facilities,” due to their lower initial capital cost and increased flexibility compared to stainless steel solutions.

Downstream

Downstream biopharmaceutical processing deals with the extraction, purification, and filtration of the products created from upstream steps. Single-use chromatography columns have streamlined the purification process, allowing for rapid and convenient separation of target biomolecules from complex mixtures. Tangential flow filtration (TFF) stands out as a pivotal technique in protein purification. Designed single-use TFF systems can be custom fit-for-purpose solutions optimized for the desired batch and final target volumes while minimizing recirculation loop sizes. Biopharmaceutical manufacturing companies leverage single-use systems to optimize resource utilization, enhance product yield, and expedite overall production.

Fill-Finish Operations

Fill-finish operations have transformed remarkably with the advent of single-use filling systems for vials and syringes. These innovative systems have revolutionized aseptic filling and sterility assurance by eliminating the need for time-consuming and complex cleaning and sterilization processes associated with traditional stainless-steel equipment. Single-use filling systems offer a closed and pre-sterilized environment, drastically reducing the risk of microbial contamination and ensuring the highest levels of product integrity. These single-use filling systems have redefined fill-finish operations, enhancing aseptic practices and sterility assurance while bolstering operational efficiency and regulatory compliance.

Quality Control and Analytics

Quality control and analytics are crucial elements in bioprocessing to ensure the production of consistent, safe, and effective bioproducts. Single-use containers minimize contamination risks, reduce cleaning and sterilization requirements, and offer a more efficient means of collecting and storing samples than traditional multi-use containers. Alongside this, integrating single-use sensors and probes for real-time monitoring has revolutionized process control. These devices provide continuous and immediate feedback on critical process parameters, enabling timely interventions to optimize production. Moreover, the single-use nature of these sensors and probes ensures sterility and eliminates the need for recalibration between batches, enhancing both the accuracy and efficiency of bioprocessing analytics.

Challenges and Considerations

The introduction of single-use technologies has kicked off a new paradigm in bioprocessing, promising increased efficiency, flexibility, and reduced risk of contamination. However, with these advantages come challenges.

One of the primary concerns is validation and regulatory compliance. Single-use technologies, especially those used in critical processes, need rigorous validation to ensure they meet the specific requirements for product contact, sterility, and extractables and leachables (also known as E&L) testing. Regulatory bodies expect consistent and reproducible performance across batches, which may pose difficulties given the disposable nature of these systems. Moreover, because many of these technologies are relatively new, there might not be established regulatory frameworks or guidance tailored to their specific use, leading to uncertainties in the approval process.

Another challenge presented by single-use systems is the issue of standardization and compatibility. As the market has expanded, a plethora of manufacturers have emerged, each offering products with their own design, materials, and specifications. This diversity can lead to compatibility issues, especially when trying to integrate components from different suppliers into a seamless process. Interconnectivity between systems might require additional adapters or modifications, increasing the risk of leaks or contamination. As single-use technologies are often proprietary, the industry needs greater standardization to promote interoperability.

While single-use technologies help reduce the need for cleaning and sterilization, they generate significant plastic waste. This raises concerns about the environmental impact, especially since many of these plastics are specialized and not easily recyclable. Hence, companies must consider the balance between operational efficiency and the environmental footprint, looking into sustainable waste management practices to mitigate the ecological concerns related to single-use technologies.

Outlook for Single-Use Technologies

As material science progresses, it is anticipated that newer, more durable, and even more eco-friendly materials will be developed for single-use technologies, further reducing the risk of contamination and enhancing the efficiency of bioprocesses.

In tandem with these advancements, the integration of automation and robotics is expected to play a pivotal role. Robotic systems can be tailored to interface seamlessly with single-use systems, leading to more streamlined, efficient, and reproducible bioprocessing workflows. This synergy between single-use technologies and automation will not only ensure consistency but also expand the scalability of processes, from large-scale manufacturing down to smaller, more specialized batches.

This scalability becomes particularly significant in the realm of personalized medicine. As the medical world moves towards patient-specific treatments, the flexibility provided by single-use technologies will enable the production of tailored bioproducts catering to individual patient needs.

Single-use technologies, bolstered by advancements in materials and the integration of automation, hold immense potential in shaping a future where bioprocessing is more agile, efficient, and patient-centric.

Strategic Communications and Single-Use

Single-use technologies have transformed biopharmaceutical manufacturing by introducing cost-effective, flexible, and contamination-reducing solutions throughout the entire bioprocessing pipeline, from upstream activities to fill-finish operations and analytics. However, challenges like ensuring regulatory compliance, standardization, and managing environmental impacts persist. Looking ahead, advancements in material science combined with the integration of automation and robotics promise to enhance the efficiency and versatility of single-use technologies, positioning them as vital components in the evolution of personalized medicine and patient-centric treatments. Effectively communicating about the benefits and drawbacks of single-use technologies will be vital to all pharmaceutical companies.

To learn more about how Cobalt helps biopharma manufacturers and other science-focused B2B businesses with all aspects of communications, visit the Cobalt services page or contact the Cobalt team.

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