How to optimize biomanufacturing efficiency

May 13, 2024

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As the biopharma industry progresses, manufacturers face the increasing need to optimize processes in biomanufacturing in terms of efficiency, quality, and safety. Big players as well as upcoming start-ups must stay competitive on the biologics market, as the growing diversification of available products also puts pressure on their manufacturers.

But these are not the only issues surrounding efficiency in biomanufacturing, as we will discover in this article – along with Single Use Support’s solutions to address them.

Biomanufacturing – an overview

Biomanufacturing describes the process of producing medicine by the means of living organisms. It is a procedure that is heavily relied on in the pharmaceutical industry. Here, numerous innovative types of drug products may be manufactured. These include but are not limited to:

mRNA vaccines
Monoclonal antibodies
Recombinant proteins
Cell and gene therapies

Central practices in biomanufacturing encompass various stages of production, from upstream processes involving cell culturing and harvesting to downstream processes focusing on purification and formulation. Important process steps include:

Fluid management: Handling and management of fluids throughout the manufacturing process, including media and buffer solutions used in cell culture, as well as downstream processing fluids.
Pharmaceutical cold chain management: Providing biopharmaceutical products with specified temperature conditions throughout storage, transportation, and distribution in order to maintain product quality. This is particularly crucial for preserving the stability and efficacy of temperature-sensitive biologics based on proteins, cells, and more.

Sources:¹

An introduction to biomanufacturing

Efficiency in biomanufacturing is becoming even more crucial

Efficiency in the production process of biologics has always been a cornerstone of biomanufacturing. However, the significance to minimize the need for financial and natural resources as well as staff and time requirements is continually growing due to various factors.

Firstly, there is generally a rising demand for biopharmaceutical products, driven by advancements in medical science and the growing prevalence of chronic diseases. This puts pressure on the pharmaceutical industry to produce larger quantities of biologics efficiently. By 2030, the costs related to chronic diseases alone are estimated to amount to USD 47 trillion worldwide. This brings significant financial stress for healthcare systems and providers, seeking affordable drug products.

Moreover, global health challenges, such as pandemics and emerging infectious diseases, underscore the need for agile and streamlined biomanufacturing processes to respond swiftly to evolving public health needs.

Furthermore, as the biopharmaceutical industry becomes more competitive, companies are compelled to streamline their operations and reduce production costs while maintaining high-quality standards. Efficiency in biomanufacturing is not just about meeting production quotas; it's about optimizing resources, minimizing waste, and maximizing productivity to remain competitive in a rapidly evolving market.

Additionally, regulatory agencies and authorities are placing an increasing emphasis on efficiency gains in biomanufacturing, as highlighted by the “Bold Goals for U.S. Biotechnology and Biomanufacturing”, issued by the White House in March 2023. In this document, aspects like the manufacturing of cell cultures are addressed, stressing an ambitious goal: “In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies 10-fold.”²³

Efficiency challenges in biomanufacturing

Considering the various motives for pharmaceutical companies and CDMOs to make biomanufacturing more efficient, the question remains: how? Indeed, there are several levels to address in order to maximize efficiency of biopharmaceutical production workflows, the most important ones of which shall be discussed further below.

Sustainable use of natural resources

In biomanufacturing, water, energy, and raw materials are crucial resources used throughout various stages of production, from cell culturing to purification processes. Implementing strategies to minimize consumption, recycle where possible, and adopt sustainable alternatives is key to efficient resource utilization.

Energy, powering equipment and maintaining controlled environments, can be optimized through energy-saving technologies and process parameter optimization. Similarly, water benefits from efficient management practices like recycling and water-saving technologies, reducing both consumption and wastewater generation. This is necessary as water is used for cleaning and sterilization processes in pharmaceutical manufacturing, along with chemicals to ensure contaminant-free environments.

Consequently, cleaning processes have a considerable impact on the sustainability of pharmaceutical processes.

Sustainability Report: Commitment to Protecting Life and the Environment

Time efficiency

Time efficiency is not only critical to maximizing productivity and reducing costs in biomanufacturing but also plays a central role in meeting the urgent needs of patients awaiting certain biopharmaceutical products. In the pharmaceutical supply chain, time directly impacts the patients' access to potentially life-saving treatments and therapies.

In biomanufacturing, every step of the production process, from cell culturing to product formulation, requires careful optimization to minimize time-to-market. Delays at any stage can prolong the development and production timeline, and may result in extended wait times for patients in need. Moreover, swift production and distribution of biopharmaceuticals are crucial during public health emergencies, such as pandemics or disease outbreaks.

Yet again, scalability has to be taken into consideration, as certain processes may be efficient on a smaller level while proving to be unsuitable for bulk production.

Scalability of single-use drug substance production

Cost efficiency in the production of biologics – at any scale

When you're a manufacturer or CDMO, cost efficiency throughout all scales is another critical consideration in biologic production, where the optimization of expenses plays aims to ensure sustainable operations and competitive pricing. You may want to establish efficient cost management strategies that encompass various aspects of the production process, from raw material procurement to downstream processing and distribution.

For that matter, optimizing production processes for maximum yield and productivity is essential. This includes streamlining manufacturing workflows, reducing cycle times, and minimizing downtime through predictive maintenance and automation technologies.

Are your struggles financial drawbacks or combating delays for patients? Reducing product loss will help you reach a higher production yield. One approach to achieve this is by reducing the amount of manual intervention within a production line by the means of automated solutions, preserving a sterile environment characterized by standardized processes.

Download Case Study

Reducing Product Loss | Cost-Efficiency

Efficient allocation of human resources

The thorough allocation of human resources is particularly integral in light of the challenges associated with manual handling. Trained personnel are essential for ensuring the quality and safety of biopharmaceutical production processes. However, skilled labor is increasingly scarce, making it crucial to optimize workforce utilization.

Moreover, manual handling increases the risk of mishandling, contamination, and workplace accidents. As a result, there is a growing recognition of the need to reduce reliance on manual operations and transition towards automation. Automation not only minimizes the risk of incorrect handling but also improves process consistency, cGMP compliance, and throughput.

By automating repetitive and labor-intensive tasks, biomanufacturers can free up skilled personnel to focus on more value-added activities. Moreover, automation enhances safety by reducing the potential for human error and contamination – an advantage that is further underlined when combining automation with single-use technology.

More than a trend: Efficiency gains with single-use technologies

Single-use technologies are revolutionizing biomanufacturing by offering significant efficiency gains across various aspects of production. These technologies encompass a wide range of disposable equipment and systems, including bioreactors, filtration units, and tubing assemblies, which are used once and then discarded.

One key advantage of single-use technologies is their ability to streamline production processes by eliminating the need for cleaning and sterilization of durable stainless-steel installations between batches. This minimizes downtime and staff requirements. Additionally, single-use technologies minimize the risk of cross-contamination and product carryover.

Coupled with automation technology, single-use solutions can not only reduce water and energy consumption, but also increase manufacturing flexibility and accelerate time-to-market for biopharmaceutical products.

IRIS Single-Use Assmeblies_Production Kufstein-29

Merging efficiency with quality standards: Process solutions by Single Use Support

Both efficiency and product quality are unnegotiable. Single Use Support offers a range of cutting-edge process solutions tailored to meet specific demands in biomanufacturing.

From aseptic filling to fluid management and freezing platforms, Single Use Support provides comprehensive solutions that optimize efficiency while upholding the highest standards of quality.

Aseptic Filling and Filtration in biomanufacturing

A central pillar in Single Use Support’s fluid management solutions in the production of biosimilars and biologics is RoSS.FILL, a fully automated single-use aseptic filling and filtration system. RoSS.FILL redefines the filling process by offering unparalleled flexibility, scalability, and speed. With the capability to fill at speeds of up to 300 liters per hour, RoSS.FILL ensures rapid throughput without compromising precision or sterility. The volumes that this platform is able to process ranges from a few mL up to hundreds of liters.

A key advantage of RoSS.FILL is its fully disposable closed fluid path, which eliminates the risk of cross-contamination and streamlines the filling process. Moreover, RoSS.FILL can integrate all available filters with the option to perform PUPSIT. The modularity enhances reliability and simplicity in bulk drug substance production while maintaining consistent product quality.

RoSS.PADL, a scalable kneading platform designed to achieve a uniform mixture in single-use bags, can be connected to RoSS.FILL with ease. Equipped with integrated cooling and heating capabilities, RoSS.PADL maintains optimal temperatures consistently, while ensuring the homogeneity of biopharmaceutical formulations. By minimizing variability and ensuring product uniformity, RoSS.PADL contributes to enhanced process efficiency and aliquot-to-aliquot product quality.

Fill & Filtration Platform

Efficient cold chain management for biologics

To address the critical need for efficient freezing of biologics, Single Use Support offers RoSS.pFTU, a state-of-the-art freezing platform. RoSS.pFTU provides solutions for freeze/thaw processes from lab to bulk scale, compatible with batch sizes and bags from various manufacturers.

Powered by plate-freezing technology, RoSS.pFTU can reach temperatures as low as -80°C while maintaining previously configured freezing rates which are predefined according to the individual product’s requirements. In contrast to slow uncontrolled freezing, plate freezing minimized detrimental effects of freeze-thaw processes of biosimilars and biologics – like cryoconcentration or intracellular ice formation.

RoSS.LN2F can achieve even cryogenic temperatures while not compromising on process control. The cryogenic freezer is able to freeze down to -170°C by the means of liquid nitrogen. However, there is no direct contact between the drug substance and LN2, which would impact overall control over the freezing process.

Once biologics, biosimilars or their respective intermediates have been frozen, they require a temperature-controlled environment to be stored and shipped. For the safe storage of biologics, Single Use Support offers the ultra-low temperature freezer RoSS.FRDG. It comes with a flexibly customizable inner shelving system and is able to store both RoSS® Shell and other types of protective packaging in different sizes with high density while maintaining temperature stability down to -75°C.

By offering a comprehensive suite of process solutions, Single Use Support empowers biomanufacturers to merge efficiency with quality standards seamlessly. From aseptic filling to fluid management and freezing platforms, Single Use Support's innovative solutions optimize every stage of the bioprocessing workflow, ensuring reliable and consistent production outcomes.

Freeze & Thaw Solutions