Innovations in synthetic biology are essential to enable efficient and cost-effective biomanufacturing of products that could replace petrochemical processes and/or allow the introduction of novel products. To ascertain differing perspectives on the unmet technological needs of synthetic biology platforms and uncover insights that could accelerate their advancement, Lux recently conducted a series of interviews with industry stakeholders. Below, we highlight three key themes from these Voice of Industry conversations.
Feedstock is the most expensive component of an efficient biomanufacturing process, yet companies often overlook what, when, and how to source it.
Most bioproduction platforms are initially developed using pure, highly concentrated glucose at lab scales, but scaling up, sourcing high-purity sugars in large quantities is costly as sugar farming for such feedstocks requires significant land, water, and labor. Moreover, the exclusive use of these feedstocks imposes regional limitations on biomanufacturing, as operations must be located favorably to regions with sugar farming capacity and purification capabilities or prepare for significant transportation costs and other considerations (e.g., temperature control and seasonal variability). Given the expense of sourcing high-purity sugars, platforms are emerging looking to expand into alternative feedstocks, including crude sugars, lignocellulosic biomass, and captured-carbon sources like CO2, to name a few. As one APAC biomanufacturing company (chemicals and CPG) stated, “There is a lot you can do in your process to use lower-cost feedstocks. Get as unrefined and upstream as possible…. A lot of good work is happening to develop bioprocesses that use next-generation feedstocks.” Designing a bioprocess for feedstock flexibility, incorporating regional crops — inputs besides highly pure and refined sugars — and seasonal variations, as well as planning for transportation considerations, can meaningfully reduce production costs.
Infrastructure is key, not just in terms of availability but also in terms of compatibility.
The recent surge in biomanufacturing infrastructure development following a rise in scale-up investment is failing to align with industry-specific needs, as more capacity has been made available, but it’s not necessarily compatible with the needs of developers today. While organizations offering piloting support and commercial contract manufacturing organizations have expanded their capacity to accommodate developers looking to scale their platforms, two sticking points remain. First, there’s not enough sustained demand for existing capacity. Second, much of the existing infrastructure is too generic to serve industries where demand persists. As one American biomanufacturing scale-up and financing partner stated, “The notion that ‘if you build it, they will come’ is not the right strategy, particularly when offering commercial-scale capacity…. You must configure your facility for a specific purpose.” Targeted infrastructure remains a critical unmet need, particularly in food- and pharma-grade manufacturing, which need compliant regulatory environments for downstream approval. Additional gaps remain in production scale, as a wealth of capacity exists for pilot-stage operations, but little support is available for demonstration-to-commercial scale-up.
Innovators continue to underestimate the technical and financial challenges of developing scalable platforms.
The path to developing commercial synthetic biology platforms is fraught with technical challenges, like navigating mutation and contamination, enzyme instability, sterility maintenance, and process variability, to name a few. While many startups emerge from academic projects with strong technical expertise in the lab, they often struggle to scale successfully due to a lack of industrial experience and tailored scale-up training within academia. Consequently, many innovators continue to underestimate the technical complexities involved in bringing a biomanufacturing platform to commercialization. One American biomanufacturing company (chemicals and CPG) noted, “Out of 150 companies we’ve worked with, the overwhelming space still believes that their 2-L operation will scale to 100,000 L.” Additionally, underrepresented financial considerations like process energy costs can stall scalability and commercialization. These challenges demonstrate where bioprocess developers could be more strategic in anticipating hurdles, factoring failed batches and variable energy costs into their budgets.
Ultimately, the success of synthetic biology, and biomanufacturing more broadly, depends on a holistic approach — integrating feedstocks, organisms, production platforms, infrastructure, and target products from the outset. While technical bottlenecks are better understood now than a decade ago, commercial-scale success remains at least five years out without significant restructuring of both technical platforms and business models. Stronger collaboration between academia, startups, and industry leaders is non-negotiable. Without it, biomanufacturing will continue to face costly delays on a prolonged path to widespread adoption.
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