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In This Issue
President's Perspective: The Importance of Engineering and the NAE
Guest Editors' Introduction: Advanced Biomanufacturing for Medicines
Transforming Manufacturing to Continue Leading the Innovation of Biopharmaceuticals
Biopharmaceutical Manufacturing Platforms: Breaking Away from Our Past
NIST Biomanufacturing Reference Materials: Development, Applications, and Impact
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Summer Bridge on Advanced Biomanufacturing for Medicines
June 16, 2025 Volume 55 Issue 2
This issue of The Bridge features cutting-edge perspectives on the rapid progress and innovation in advanced biomanufacturing for medicines.

Transforming Manufacturing to Continue Leading the Innovation of Biopharmaceuticals

Monday, June 16, 2025

Author: J. Christopher Love

Maintaining US leadership in the biomanufacturing sector requires investment in groundbreaking biomanufacturing technologies.
Biopharmaceuticals have become essential medicines for preventing and treating diseases ranging from cancer and autoimmune disorders to ­neurological conditions, complementing vaccines and small-molecule pharmaceuticals. Derived from biological sources, they include monoclonal antibodies, mRNA therapies, engineered viruses, and cell-based therapies, among others. The global biologics market exceeds $500 billion and represents approximately half of all approved new medicines (Senior 2024).
 
Manufacturing these medicines is more challenging than manufacturing traditional small-molecule drugs (e.g., acetaminophen). The processes rely on dynamic living cells to produce complex active biological substances. Over the past 40–50 years, the industry has developed reliable manufacturing practices to deliver these life-saving treatments to patients.
 
This adolescent industry now faces new challenges to continue its growth. At least three external forces—rapidly diversifying therapeutic pipelines, shifting geopolitical risks and global competition, and demands for long-term ­sustainability—are converging to require new agile and flexible manufacturing strategies to ensure the timely and efficient delivery of new medicines from concept to patients. Without continued innovations in manufacturing practice itself and strategic infrastructure for a broad biomanufacturing base, the United States in particular risks losing its leadership in this sector.
 
The State of the Industry and Manufacturing Today
Breakthroughs in recombinant DNA technologies and genome-scale biology gave birth to the modern bio­pharmaceutical sector. The promise—and increasingly realized potential—of biologic medicines are their precision for targeting disease and their general safety, compared to small molecule drugs. The complexity of these products is significant, however. Biomolecular or cellular materials can vary in many ways and can impact their safety or efficacy. Biopharmaceuticals are typically produced using genetically engineered living cells, such as Chinese hamster ovary cells, yeast, or bacteria. These cells express therapeutic proteins or engineered viruses that in turn are purified from the residual complex mixture of cellular components (DNA, other proteins). The industry has optimized processes to make these products despite their complexity, relying predominantly on highly centralized, bespoke facilities to achieve consistent supply to the market.
 
Scale and Industry Structure
Compared to other industrial sectors, bio­pharmaceuticals remain both small in production volumes and highly ­specialized as products. Chemical manufacturing (including pharmaceuticals) routinely produces millions of ­metric tons of products annually compared to tens of metric tons per year for all biopharmaceuticals and vaccines. There are also ∼5-10 times more registered small molecule pharmaceuticals; the 100th monoclonal ­antibody (mAb) was just approved in 2021 by the Food & Drug Administration (FDA) (Mullard 2021). This low mix of moderate-volume products, coupled with the operational oversight needed for the complex, highly manual processes to assure consistent high-quality products, has contributed to an industrial structure wherein a handful of large biopharma companies and contract development and manufacturing organizations (CDMOs) control most of the global capacity for manufacturing (Kelley et al. 2021).
 
This structure contrasts with other mature industries such as the aerospace/defense industry, where large manufacturers rely on a robust network of small and medium enterprises as subcontractors and key suppliers for parts to form a manufacturing base. The structure more ­closely aligns with that of the semiconductor industry, where historically a small number of manufacturers have produced most chips supplied to the market. Much like the biopharmaceutical sector, the semiconductor industry has evolved to separate innovation and manufacturing. ­Various innovator companies design new chips manufactured by a small number of other companies (or predominantly one today [Taiwan Semiconductor Manufacturing Company (TMSC)]). This dynamic is similar for small biotechnology companies advancing new assets for acquisition by large biopharmaceutical companies.
Without continued innovations in manufacturing practice itself and strategic infrastructure for a broad biomanufacturing base, the United States in particular risks losing its leadership in this sector.
Long timelines to bring products to market—along with high drug prices in the United States and ­elsewhere—have reinforced the sector’s structure. Venture capital-backed biotechnology companies rely on partnerships or licensing and contract manufacturing to achieve key value inflections and the sale of the company/assets pre-­commercially. Large companies in turn recoup their research and development (R&D) investments in the commercialization of the products acquired through sales. Only a limited set of large innovator companies today have the capital resources to absorb these expenses and maintain the comprehensive manufacturing, clinical, and regulatory capabilities necessary for commercial sales. There is an increasing divide between the innovation of biopharmaceuticals and their manufacture.
 
Regulatory systems have further codified this highly centralized manufacturing model. Historically, limited capabilities to characterize clinically relevant attributes of these complex products have led to guidance for extensive characterizations of the processes themselves as a partial proxy—the so-called “the product is the process” perspective (Geigert 2019). Uncertainties in scaling processes and the high degree of expert knowledge needed can add ∼20-40% to the overall cost of manufacturing a drug throughout its commercial lifecycle (Mahal, Branton, and Farid 2021). With a predictable, successful cadence for financing and approval in an era of globalization, there has been little urgency to reform this structure or underlying manufacturing practices beyond those that enhance operational efficiency.
 
Drivers to Continue Innovating Biopharmaceutical Manufacturing Practices
 
The biopharmaceutical sector is not immune to three accelerating external trends: the rapid expansion of new therapeutic candidates from accelerating biological knowledge, the shifting geopolitical landscape with increased global competition, and the urgent need for more sustainable production practices. Without innovations, current manufacturing paradigms risk becoming bottlenecks to continued growth, limiting the industry’s ability to efficiently translate breakthrough discoveries into life-saving medicines for patients worldwide.
Without innovations, current manufacturing paradigms risk becoming bottlenecks to continued growth, limiting the industry’s ability to efficiently translate breakthrough discoveries into life-saving medicines for patients worldwide.
The Explosion of Therapeutic Candidates is Outpacing Manufacturing Capabilities
The sheer rate of discovery in biology—and the tools to engineer it—are outpacing the ability to advance bio­manufacturing processes to support their commercialization at scale. The landscape for new therapies has changed substantially in the last five years. The number of approved monoclonal antibodies reached 50 in 2015 but then surpassed 100 in 2021. Advances in genomics, immunology, and gene editing are fueling an unprecedented pipeline of potential therapies (Barbosu 2024). Mature protein engineering and nascent artificial intelligence (AI)-driven protein design have rapidly expanded the diversity and complexity of protein-based ­therapeutics in pipelines (Notin et al. 2024). The ­COVID-19 ­pandemic validated nucleic acid-based products like mRNA that require entirely different manufacturing than protein-based biologics. Cell and gene therapies have emerged as an important class of complex biologic products as well for cancers and genetic conditions.
 
There is, therefore, a growing mismatch between the speed of drug discovery and the capacities for industry to develop and validate manufacturing processes for commercialization and for regulatory agencies to review them. There simply are not enough trained personnel, development resources, or manufacturing infrastructure to support the timely advancement of novel therapeutic candidates emerging from academia and biotech startups around the world.
 
Geopolitical Shifts and Competition Threaten Global Supply Chains and Markets
The biopharmaceutical industry today relies heavily on globalized supply chains to support its centralized production hubs. Drug substances manufactured in one country are often finished into final drug products in another. Rising geopolitical tensions, supply chain disruptions due to unpredictable global events, and shifting trade policies make this model increasingly fragile, however. 
 
Governments worldwide are prioritizing both national and economic security. They have implemented a range of policies introducing trade barriers and encouraging local, end-to-end manufacturing. Countries such as ­China, India, Canada, and France have made large public and private investments in both state and private contract development and manufacturing organizations (CDMOs) to secure domestic manufacturing capabilities. 
 
The US-centered advantage in biotechnological innovation is diminishing. Faster timelines for regulatory reviews and lower costs for development in other regions of the world are leading to new follow-on or “me too” products targeting similar pathways or mechanisms as existing innovator drugs, as well as biosimilars. These products are beginning to gain approval in the United States, presenting new competition for US biotechnology ­innovators. Examples include Biocon’s insulin glargine, which has been approved for the US market, and innovative new Chinese-designed biologics (Agten and Wu 2024).
 
Supply chain resiliency presents another emerging risk. Many critical raw materials, including media additives, plastics, and other specialized reagents, are sourced from global markets, including China. Trade restrictions, ­tariffs, or export bans by one or more countries will impact US- and European-centered biopharmaceutical production, increasing costs and potentially delaying drug availability. Considerations for alternative models, including more vertical integration within companies, may be essential to enhance self-sufficiency in reliably delivering products to market.
 
Sustainability Demands More Resource-Efficient Biomanufacturing
Biomanufacturing today requires disproportionately large amounts of water, energy, and chemicals compared to the volume of the final product, largely due to the low conversion rates of the biological systems used in production and the strict aseptic conditions needed to maintain ­quality. Process Mass Intensity—a simple ratio of raw materials input to final product output—is 1,000 times greater for biopharmaceuticals than for small-molecule drugs or fine chemicals (Budzinski et al. 2019). More than 90% of the input mass is water (Madabhushi et al. 2018), an inefficiency similar to that found in semiconductor manufacturing. As global efforts to address sustainability intensify, this sector (like all industries) will face pressure from the public to reduce its environmental footprint while also attempting to expand access to therapies worldwide.
 
There is an emerging transition from fixed stainless-steel bioreactors to single-use technologies (SUTs)—a counterintuitive shift offering substantial benefits for sustainability. Disposable process materials generate plastic waste, but they also eliminate intensive processes using steam and chemicals for sterilization and reduce energy use (Ottinger et al. 2022). Further ­process ­intensification—achieving higher product yields in ­smaller, more efficient facilities—is still needed, however, to make bio­manufactur­ing truly sustainable. Expanding biomanufacturing capacity today without addressing sustainability challenges could impose further strain on global resources and introduce other unintended consequences with the corresponding supply chain expansion. 
 
Together, these extrinsic factors are dynamically and rapidly reshaping the environment in which the bio­pharmaceutical sector operates. They add increased uncertainty on operational strategy, increased competition for regulatory review and indication areas, and increased scrutiny on pricing and business practices that impact global health and sustainability. 
 
Reassessing Biomanufacturing for a New Stage of Growth
 
The changing landscape of the sector provides an opportunity to re-evaluate the assumptions underlying bio­pharmaceutical manufacturing optimized for a globalized economy led by US-centric innovations in biotechnology. It is useful to consider whether the present assumptions are still sufficient to address both the pace of innovation and the needs of the global population (IAVI/Wellcome 2020).
 
Limitations of Today’s Biomanufacturing Model for Tomorrow
The biopharmaceutical industry today has focused primarily on a common manufacturing paradigm for the dominant class of products—mammalian-based expression systems with well-defined steps in purification and recovery for monoclonal antibodies (Kelley 2009). Steady, incremental process improvements, principally aimed at increasing operational efficiency with fed batch-based processes, have yielded remarkable gains in productivity. For instance, monoclonal antibody titers have improved by nearly 100-fold since the early 1990s with process optimizations. A large network of facilities exists today to accommodate approved products with some capacity for new candidates.
Expanding biomanufacturing capacity today without addressing sustainability challenges could impose further strain on global resources and introduce other unintended consequences with the corresponding supply chain expansion.
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Establishing new manufacturing capacity remains expensive and time-consuming (figure 1). Building and validating a conventional stainless-steel facility to produce monoclonal antibodies at scales of approximately 1-10 metric tons per year can require investments approaching $2 billion and three to five years to complete (Kelley et al. 2021). Even smaller-scale facilities for clinical-stage production today cost $100-200 million and take three years to complete. This economic ­barrier hinders creating a more robust manufacturing base for production and forces innovators (without commercial revenues) to wait on contract manufacturing until capacity becomes available. CDMOs for mammalian-cell-based biologics report operating at 65-80% of capacity with some regional variation, but the practical available capacity—particularly for small volume production like IND-enabling lots of proteins other than mAbs—can be much less than the apparent unused capacity due to long lead times, unique process requirements, or geographic/logistical constraints for supply (BioPlan Associates, Inc. 2022). This structural challenge to expansion in turn ­limits the number of innovative therapies that can be evaluated annually and adds costs to development by delaying initial (and subsequent) clinical trials. 
 
Shifting Scales of Demand
The industry is also experiencing a bifurcation in manufacturing needs. Many new therapeutic candidates are designed for low doses (e.g., bi/trispecifics) or smaller populations, including personalized cell and gene therapies and biologics tailored to well-defined or rare diseases. These present a need for “small-volume, high-mix” manufacturing capabilities that can generally benefit from agile, standardized approaches to scale or adapt predictably without incurring the cost of large, specialized facilities. Examples from other sectors include foundries for semiconductors, where standardized processing tools allow for different chip designs, or the Tesla ­Gigafactories that can reconfigure to address current demand and products. 
 
Some products will continue to need “high-volume, low-mix” biologics that may exceed tens or even hundreds of metric tons in annual demand for a global population. Examples include insulin products (∼40-50 metric tons today estimated from global disease burden [Magliano et al. 2021]), weight management therapies based on ­semaglutide, and antibodies for infectious or neuro­degenerative diseases (Kelley, Renshaw, and Kamarck 2021). Such products will benefit from large-scale facilities optimized for maximum throughput of individual products to realize cost efficiency. The current industrial manufacturing strategy is better positioned to address this scenario than that for agile and flexible production.
 
The Business Rationale for Advancing Distributed Biomanufacturing
Complementing the currently installed infrastructure for manufacturing, establishing new modular, small-footprint solutions designed for various product classes (proteins, cells, mRNA, virus) could enable agile, standardized biomanufacturing, expanding the manufacturing base and mitigating external risks. For small- and mid-sized biotech, modular platforms would reduce capital and operational complexities. Lower barriers to in-house production help circumvent long timelines and high costs of contract services while improving quality control and retaining intellectual property. Rapid access to manufacturing in early development can foster faster iteration and commercial development (Berger 2013). Distributed modular systems for regionalized production in other industries like automobiles have been used to strengthen the resiliency of supply chains and diversify the risk of disruptions (Shih 2020), though this model does require regional access to suitable raw materials and supplies as well.
 
Large pharmaceutical companies can also benefit from the agility provided by standardized modular systems across multiple product classes, making the transition from clinical to commercial production more predictable and resource efficient. Retrofitting needs can be minimized, enabling swift responses to changing pipelines or market demand. Modular facilities may also allow ­selective in-house production of key materials like growth factors or enzymes, reducing reliance on external suppliers. One key advantage is “scaling out” rather than “­scaling up.” Instead of committing to a multibillion-­dollar facility for uncertain demand, organizations can incrementally expand capacity, lowering risks of overbuilding or underutilization (Pollard et al. 2016; Walther et al. 2015). Novel financing—through public-private partnerships, regional consortia of smaller enterprises, and academic-­industry-government-supported non-profits like ­Landmark Bio—could further expand the manufacturing base and accelerate product development (Asin-Garcia et al. 2024). Rather than replacing large-scale operations, this model would add capabilities for speed, flexibility, and resilience; reduce capital costs; shorten time-to-market; and broaden patient access to cutting-edge therapies.
 
Enabling Distributed Biopharmaceutical Manufacturing
 
Advancing a sustainable distributed manufacturing model requires identifying where current practices can be enhanced to overcome the inertia of implementing a new model.  A highly optimized facility design and operations to support manufacturing monoclonal antibodies is based on efficient scheduling and use of materials (­primarily chromatographic resins) to achieve low costs of goods manufactured (COGsm) (Kelley 2009). Analyses and implementation of continuous bioprocessing have shown the potential to reduce the capital costs and timelines to construct facilities and offer competitive costs for the COGsm (Mahal et al. 2021; Partopour and Pollard 2025; Walther et al. 2015). There is an emerging consensus process for continuous production of recombinant proteins by mammalian cells (Coffman et al. 2021). The configuration uses direct pairings of one bioreactor with one line for recovery using SUTs, sized according to the volume/mass of product/fluids processed.
 
Analyses on COGsm that compare continuous processes to both traditional stainless steel and single-use, fed batch operations offer key insights into the beneficial features they afford. Continuous operations can offer similar COGsm as traditional stainless-steel batch configurations, even with increased development costs and additional testing for quality arising from smaller batches (Mahal et al. 2021). This approach also can reduce CO2 equivalents by over 50% due to the smaller facility (and energy use for ventilation and air handling) and equipment (Partopour and Pollard 2025).
 
The convergence of continuous processing and SUTs provides a basis for how to enhance agility, speed, and flexibility. Contributions to COGsm include the fixed capital investment (the facility and associated costs) and its operations (labor, materials, quality assurance), as well as those associated with process development. Reducing complexity or time required for each can directly reduce both the upfront capital investment and ongoing costs of manufacturing (recurring cost per gram). Three general areas for continued innovation are process intensification, standardization, and process consolidation.
 
Process Intensification
Increasing space-time yields while minimizing volumetric footprints of facilities (mass per unit volume fluid processed per time for a given cubic volume of space) is a critical goal to realize capabilities for distributed production (Crowell et al. 2024). The basic tenets are simple: Improve yields for process steps, reduce the total number of process steps, and reduce the total space required to operate the process steps while managing the input and output materials. The current platform for producing monoclonal antibodies has very effectively improved the yields on both the bioreactor process and downstream recovery to where further gains now require improved capacities of the chromatographic resins and reduced ­volumes/costs of media (Partopour and Pollard 2025). This current state for monoclonal antibodies, however, is neither representative of the state for all other recombinant proteins (e.g., insulin, vaccine subunits) nor the limit for process intensification. Further gains would enable even smaller facilities (lower capital investments in facility and equipment and lower operating costs with fewer input materials).
 
Removing low-value, or non-value-add steps, like hold tanks and buffer tanks in a process, can reduce material, labor, and space requirements. In-line dilution systems and other mixing systems are one solution to removing buffer preparation equipment and space (Ram et al. 2023). Straight-through chromatography, where there are no additional holds or adjustments between serial ­chromatographic steps, can also reduce the number of buffers required and can potentially eliminate entire columns in a sequence (Crowell, Rodriguez et al. 2021; ­Vecchiarello et al. 2019). 
 
Further reductions in process operations can be achieved by changing the host biology used to catalyze the conversion of raw materials into drug substance. Options for hosts were historically constrained without tools to characterize the product extensively or to engineer the cells. Today, these constraints have been removed with deep analytical capabilities like mass spectrometry and genome editing/sequencing technologies. Cells have been engineered to produce human-like glycoproteins with commercially relevant titers (Ye et al. 2011). ­Aglycosylated antibodies, cytokines, growth factors, nanobodies, and AI-designed proteins are all well suited for alternative hosts. Conservative modifications to ­molecular ­sequences can also render them more host-agnostic (Yang et al. 2025). Advancing capabilities for alternative host cells would allow removal of viral filtration/inactivation steps and Protein A chromatographic steps (Coleman 2020), reduce the numbers of chromatographic steps (for non-mAbs) (Crowell et al. 2018), and reduce the ­facility infrastructure, material costs, and development time spent on those operations. Faster growth rates also reduce the cycle times in iterating on process development or clonal development (Brady and Love 2021). Leveraging the same advances in bio­technology accelerating drug development can benefit the manufacturing development as well (Dalvie, Brady et al. 2021). The benefits of the host extend well beyond the bioreactor, and they offer the single greatest (and most underdeveloped) “knob” to transform process intensity.
 
These combined features make it feasible to establish so-called “platform” processes for a multiplicity of non-mAb proteins like cytokines, nanobodies, Fc fusion proteins, vaccine subunits, and others. The reduced complexity of the overall process in turn makes predictive capabilities for process development possible, including relating protein sequences to process conditions (Crowell, Goodwine et al. 2021). More predictive and deterministic process development could reduce costs and time to the clinic. As an example, at the outset of the ­COVID-19 pandemic, we developed a new end-to-end process and generated phase-appropriate proteins for a subunit vaccine in 29 days from sequence to protein using the ­modular process development tools we had demonstrated in other examples (Dalvie, Rodriguez-Aponte et al. 2021). The technology transfer, however, was hindered by the global lockdown, highlighting one case where regional manufacturing could have facilitated fast response times (Brady and Love 2021).
 
Standardization
For agile manufacturing of a high mix of products, standardizing the manufacturing process is important. The same facility and equipment should accommodate different products with minimum reconfiguration. The consensus process for monoclonal antibodies relies on a standardized process, but not the facility and equipment. These elements are still adapted to the specific manufacturing company’s needs or preferences. Today’s bio­manufacturing equipment is modular for individual operations but requires plant-level integration for control of a “mix-and-match” system. This arrangement allows a certain degree of flexibility in the configuration but adds costs for configuration, interoperability, and maintenance.
 
In contrast, foundries for semiconductor manufacturing use standardized equipment and processes with little or no customization to accommodate different designs or architectures. Given the variations in biological products (cells, proteins, mRNA, viruses), one can envision standardized “all-in-one” platforms designed “fit for purpose” to produce products within a class. For example, one biomanufacturing system for proteins could produce many different types of proteins from cytokines and hormones to vaccine components, nanobodies, and antibodies with only changes in the chromatographic resins employed (Crowell et al. 2018; Dalvie, Brady et al. 2021; Dalvie, Rodriguez-Aponte et al. 2021). There are now several emerging examples of such technologies for good manufacturing practices (GMP) use (table 1).

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Fully integrated solutions designed for end-to-end production and closed bioprocessing would allow highly flexible facilities capable of multiple modalities. Such solutions also provide the opportunity to achieve true “walk-away” automation and remote monitoring or even control, reducing labor and overhead in operations. Technology transfer from one system to the next is also seamless when the system itself is standardized, much like biomedical devices or computers. Extending guidance for the FDA’s Platform Technology Designation or Drug Master Files to include manufacturing systems designed and validated for a class of products could streamline the review of new applications and accelerate the use of innovative new manufacturing systems.
 
One perspective on standardization is to unify features like connectors or communication standards (Erickson et al. 2021). This effort is analogous to standards like USB for computers. There is relatively little financial incentive for large suppliers to freely adopt this approach, and it could harm innovation from start-up companies and innovators. To support a broad manufacturing base, establishing user requirement specifications for capabilities instead would allow for continued innovation of the form of the equipment itself and promote competition on other features (user experience, software). Examples could include types of host biology, equipment features (flow rates, sensor tolerances) and materials (USP Class VI), or order of operations. This type of competition exists in other sectors, including desktop printing and additive manufacturing, to help drive innovation for features and capabilities that improve the breadth and quality of products. Broadening the range of manufacturing systems while maintaining certain requirements for specifications would also help address concerns for single-source supply of a given solution.
 
Process Consolidation
A third area to enable more sustainable and intensified biomanufacturing solutions would take advantage of the intrinsic benefits of biological systems—namely their ability to create complex outputs from common inputs. Much of today’s biomanufacturing practice has focused on controlling the complexity of biology to achieve a well-defined output (e.g., a monoclonal antibody). Cells, however, can produce multiple complex products at the same time, and naturally do so. For certain classes of products, simultaneous production of multiple components of the drug could reduce the number of campaigns or testing required. 
One example is the contemporaneous expression and purification of a multivalent subunit vaccine using one host cell (Dalvie, Brady, et al. 2021). For a trivalent vaccine, this consolidation reduces the total number of campaigns required by threefold. For certain immunotherapy combinations in oncology or raw material generation for defined media for cell therapies, this type of approach could offer advantages over preparing each component individually. There is no regulation that prevents such an approach, and many less defined products are licensed (immunoglobulins from sera; attenuated vaccines). Advances in engineering biology offer the potential to add conditional controls to the cell lines to maintain relative expression levels. 
 
Conclusions
 
The biopharmaceutical industry has achieved remarkable success both in terms of market growth and impact for patients. These successes have resulted from significant investments in time and thought by the people who have advanced the current manufacturing practices. The state of the world and the industry are changing rapidly, though. There is an increasingly urgent need to ­reconsider how to strengthen the biomanufacturing capabilities in the United States and abroad (NSCEB 2025).
Maintaining US leadership in this sector will now require true “leapfrog” innovations in manufacturing. In 1928, penicillin was discovered in the United ­Kingdom—a leader in science and technology innovation at that time. Manufacturing that critical medicine was outsourced to the United States with its significant capacity and knowledge on deep-tank fermentation and at-scale processing. The United States has held the economic benefits of biotechnology since then. Nearly four out of five US biotechnology companies now rely on manufacturing capacity overseas. The time and financial resources needed to reshore that capacity are significant and growing.
 
The technologies exist to develop a more robust biomanufacturing base that does not depend on centralized production with narrow supply chains to deliver new medicines to patients. There are indeed challenges to realizing modular and distributed manufacturing with lower capital barriers for entry that are similar but different from those faced at the beginnings of this sector. Further development and partnership across academia, start-ups with innovative new technologies, industry, and regulatory agencies can begin to realize a new paradigm that provides broad access to these medicines and the ability to make them. A decision to not invest with haste in groundbreaking new biomanufacturing technologies and establish a distributed, resilient base is one the industry and country should soberly consider.
 
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Yang Y, Dalvie NC, Brady JR, Naranjo CA, Lorgeree T, ­Rodriguez-Aponte SA, Johnston RS, Tracey MK, Elenberger CM, Lee E, and 3 others. 2025. Adaptation of ­aglycosylated monoclonal antibodies for improved production in ­Komagataella phaffii. Biotechnology and Bioengineering 122(2):361–72.
Ye J, Ly J, Watts K, Hsu A, Walker A, McLaughlin K, ­Berdichevsky M, Prinz B, Kersey DS, d’Anjou M, and 2 ­others. 2011. Optimization of a glycoengineered Pichia ­pastoris cultivation process for commercial antibody production. Biotechnology Progress 27(6):1744–50.
About the Author:J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering at MIT and director of the MIT Alternative Host Research Consortium. He is a co-founder of Sunflower Therapeutics, PBC.