Reimagining Global Biomanufacturing Capacity with Continuous and Modular Systems
Dr. Kerry Love, Co-founder and CEO, Sunflower Therapeutics
Traditional biomanufacturing, while appropriate for some applications, if capital intensive, slow to adapt, and concentrated in certain geographies. Meanwhile, modular biomanufacturing is focused on speed and adaptability and can scale quickly. This article would highlight how modular systems shorten development timelines for small biotechs and foster innovation across pharma, food, and industrial biotech sectors.
Biotechnology is fueling the ongoing expansion of the global market for a broad array of goods. Factors like population growth, chronic and infectious diseases, and climate change are driving the growth in the protein bioeconomy alongside rapid expansions in knowledge, innovation, and bioengineering capabilities.
In the biotech industry, innovation is now outpacing relevant manufacturing capacity. In the past 15 years, the number of proteins entering Phase 1 clinical trials has doubled. Additionally, with the rise of precision medicine and potent AI-inspired therapies, there is now an increased need for small-batch biologics manufacturing capacity. Since 2018, 50% of new biologics are rare and orphan drugs, and 30% of the global protein therapeutics market have small volume requirements (i.e. <10 kilograms annually).
Biomanufacturing capacity must grow 20-fold by 2040 to support market growth predictions, reduce manufacturing costs, and prevent production bottlenecks. To meet this accelerating demand for bioproducts, biotech innovators need high-quality, cost-effective approaches to production and innovations that enable small-volume manufacturing capacity.
Optimizing Bioprocessing with Continuous Manufacturing
Continuous manufacturing (CM), a manufacturing process that sends materials directly and immediately to the next step of the process, is streamlining and optimising bioprocessing operations and, due to smaller unit operations and increased automation, enabling non-experts to manage complex production processes with greater ease. According to a 2022 paper by the FDA, continuous manufacturing can get products to market about 12 months faster than batch processing – a notable differentiator.
This integrated, distributable, and lower-cost manufacturing approach empowers smaller players to produce biologics like immuno-oncology treatments and enzyme replacement therapies without the need for large, upfront capital investments. In some cases, CM even allows for localized production of biologics, reducing dependency on global supply chains and increasing the availability of essential medicines in diverse geographies.
CM in biomanufacturing is also crucial for meeting sustainability goals in the industry, as it is a more efficient and eco-friendlier alternative to traditional batch manufacturing. CM utilizes smaller unit operations, decreasing the volumes of input raw materials and output waste products, while also reducing inefficiencies from downtime and operational costs, ultimately enhancing product consistency, protein yield, and throughput. By maintaining stable, optimal conditions, CM also supports accelerated production, reduces product variability, and ultimately lowers energy consumption due to smaller facility footprints with similar or greater product yields, making it an attractive option from a sustainability perspective.
Another cost savings mechanism for CM can be found in advanced process analytical technologies (PAT) integrated into CM systems. By offering a more precise method of monitoring and controlling process variables in real time, this allows manufacturers to maintain product quality and reduce the incidence or risk of errors. Because of this, there is greater process reliability and a reduced chance of batches failing to meet the required quality standards, leading to both cost and time savings. All of the benefits of CM make it a key factor in the future of biomanufacturing.
The Future of Biomanufacturing Innovation is Modular and Integrated
Traditional biomanufacturing is capital intensive, slow to adapt, and concentrated in certain geographies. It typically takes three to five years and over $200 million to build conventional biomanufacturing facilities. These types of facilities are often built for a single product type and cannot rapidly adapt to changes in product demand.
An expansion in automated facilities and an appropriately skilled workforce are urgently needed to support the capacity growth that is demanded by the market. In the face of unpredictable global market pressures, broad product pipelines, the expectation for rapid profits, and the need for low-cost protein products, shifting away from large-scale, single-product facilities to agile and flexible manufacturing strategies is paramount.
In addition to supporting capacity growth and minimizing downtime, waste, and energy utilization, CM drives cost savings by reducing manual intervention through automation, enabling manufacturers to achieve significant reductions in production costs. The compact, modular design of CM reduces space requirements, while advanced monitoring and real-time data collection systems enable predictive maintenance, further reducing operational disruptions and costs.
Increasingly, CM also adopts a single-use approach, decreasing the need for batch transitions and extensive cleaning, leading to both time and resource savings. This single-use approach, combined with the modularity of CM, also enables multiproduct flexibility.
The flexibility and modularity of CM systems allow manufacturers to scale operations up or down or choose to produce different products depending on actual market demand versus pre-commercial projections and aspirations. This – along with lower overhead costs and predictable, fixed costs associated with a modular, microfacility-like approach – makes it easier to respond to market fluctuations without the need for significant capital investment.
Continuous Manufacturing’s Role in Reducing Workforce Barriers
According to BioPlan Associates’ Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, biomanufacturers and suppliers have been unable to hire and retain both new and experienced production staff. In fact, the most pressing factor expected to constrain facilities’ biologics production capacity over the next five years is the ability to find both new and experienced technical and production personnel.
CM can help address this by simplifying bioprocessing operations, as it typically operates in a steady state that requires less oversight and is easier to automate. Additionally, having a smaller facility footprint means that fewer staff are required overall, as opposed to larger facilities that often need hundreds of skilled operators. With their intuitive and modular designs, modern continuous fermentation systems, for example, can allow non-experts to manage complex processes with greater ease. Automation within CM systems also facilitates tighter control over the production environment, helping operators achieve higher precision and reliability. The reduced need for manual intervention not only minimizes human errors but also reduces the strain on operators, leading to better overall workplace safety and operational efficiency.
By implementing features like simplified interfaces, integrated controls, remote monitoring capabilities, and automated functions, these systems become more intuitive and enable users, even those with limited experience, to efficiently monitor and control production processes. This democratization of biomanufacturing technology is critical for expanding access to life-saving treatments, as it empowers smaller players to produce proteins such as therapeutics or alternative foods without the need for large, specialized teams.
Continuous and Modular Manufacturing Together Can Optimize Outcomes for Biotechnology Companies
Taking an intuitive, single-use bioprocessing approach supports biotech innovation and new entrants to the market. By reducing reliance on single-product manufacturing facilities and biofoundries that are dependent on their market share for success, new participants can emerge. For example, smaller pharmaceutical companies, biotech startups, and academic institutions can leverage these systems to manufacture their products without the need for large-scale, traditional manufacturing setups. This both lowers the barriers to entry in biotechnology and encourages a more competitive and innovative environment that drives progress in drug development. By enabling diverse protein product production, CM also helps support stable job markets and cost-effective options for consumers in diverse market segments.
As CM technology advances, it will make high-quality biologics more affordable, attainable, and faster to produce, ultimately contributing to positive shifts in regional and global healthcare delivery.
Author Bio
Dr. Kerry Love is the co-founder and CEO of Sunflower Therapeutics, a women-led biotech company focused on making protein manufacturing for medicines, vaccines, and more accessible. An MIT-trained organic chemist and biotech entrepreneur, she has founded two companies and played a key role in launching several others over the past two decades.
