Our approach represents a paradigm shift that reimagines the pharmaceutical industry through the lens of nature’s principles. Traditional approaches often rely on heavily engineered systems. This reliance on artificial technologies introduces inefficiencies, escalates costs, produces side effects on patients, and exacerbates sustainability challenges. By replacing most of that complexity with the inherent efficiency of natural processes, we are transforming how therapies are developed and delivered. This shift will eventually redefine the infrastructure, culture, processes, and tools that underpin the industry, enabling a future where healthcare is not only simpler and more effective but also seamlessly aligned with global sustainability goals, without compromising on quality.

At AGS (AGS therapeutics, www.ags-tx.com, and its manufacturing subsidiary, AGS-M, www.ags-m.com), we view biotechnology in the pharmaceutical industry as a holistic approach encompassing drug development, manufacturing, distribution, drug administration, and delivery. As such, in developing our technology, we aim to streamline all stages of this lifecycle, ensuring that therapies are not only effective and efficient but also accessible to patients and healthcare providers worldwide.

Aligned with this vision, our sustainability efforts target the environmental, social, and economic dimensions of healthcare. We are focused on reducing resource consumption, minimizing waste, and adopting eco-responsible practices across our operations and our partners. Equally important, we prioritize health equity by creating cost-effective solutions, ensuring that advanced therapies are within reach for all. Through these initiatives, we aim to foster a healthcare ecosystem that is equitable, sustainable, and resilient for future generations.

At the heart of this transformation are extracellular vesicles from microalgae (MEVs), a universal drug delivery system for human therapeutics, vaccines, and gene therapies. These MEVs harness a two-billion-year-old natural technology, refined by evolution, to provide unparalleled efficiency and safety. By leveraging the innate stability, biocompatibility, and scalability of microalgae-derived vesicles, we can address complex healthcare challenges while reducing reliance on synthetic, resource-intensive, and waste-generating processes. This innovation epitomizes our commitment to blending nature’s principles with cutting-edge science to deliver therapies that are effective, accessible, and aligned with the imperatives of sustainability.

Today’s drug production demands vast amounts of resources, including energy, water, organic solvents, synthetic materials, animal-derived components, and sometimes viral vectors. These inputs create substantial environmental impacts, from increased greenhouse gas emissions to the generation of hazardous waste. The widespread use of single-use plastics and complex, expensive infrastructure further compounds these challenges. Moreover, the pharmaceutical industry’s resource intensity poses risks to ecosystems and places a significant burden on waste management systems.

Equity and accessibility remain critical issues. Many existing therapies are invasive, or highly invasive, making them difficult to administer and less likely to be followed by patients. The use of drug delivery systems like adeno-associated viruses (AAVs) and lipid nanoparticles (LNPs) introduces additional complications. While AAVs offer targeted delivery, they carry risks of immune responses and high costs, i.e. inequity, concerns. LNPs face challenges related to poor biodistribution, toxicity, the massive use of hazardous organic solvents, and the need for complex storage and transport logistics. These systemic issues underscore the need for innovative solutions that balance efficacy, accessibility, and sustainability.

Despite these significant shortcomings, the pharmaceutical industry largely accepts the status quo, perpetuating inertia and an undue reliance on established mental models, which, while useful, are inherently flawed. Yet they dominate industry practices due to familiarity and entrenched investment. This persistence leaves little room for critical questioning. To break this cycle, targeted innovation and substantial funding are urgently needed to redefine the pharmaceutical industry for the better.

MEVs are produced using Chlorella, a genetically stable and renewable microalgae species generally recognized as safe (GRAS). The manufacturing process is resource-efficient, requiring only light, salts, and water. This eliminates the need for synthetic components, organic solvents, and animal-derived materials, significantly reducing water usage and the overall environmental footprint. The process involves the production of general-purpose MEVs from wild-type (non-GMO) algae, where waste algae and water can be recycled, further enhancing sustainability. These MEVs are versatile and can be stored long-term, ready for use with any therapeutic, vaccine, or gene therapy payload, streamlining production and distribution.

MEV production supports high-volume scalability, minimal waste generation, and compatibility with various payloads, including mRNA, siRNA, proteins, peptides, and small molecules. The Chemistry, Manufacturing, and Controls (CMC) process for MEVs is common and shared across all payloads of the same payload type, and the platform is advancing toward a single, unified CMC process for all payload types. This soon-to-be GMP-compliant innovation simplifies drug development and regulatory approval, significantly reducing both timelines and costs.

Therapies developed with MEVs are stable for long-term storage and can be delivered through non-invasive methods such as pills or sprays, reducing the reliance on single-use plastics and disposable materials. Formulation, distribution, routes of administration, biodistribution, uptake, and delivery depend entirely on the MEV itself, which remains consistent across all payloads. This quality simplifies and unifies the entire therapeutic approach, making it more efficient and scalable.

From a sustainability perspective, MEVs excel across environmental, social, and economic dimensions. They minimize resource consumption, eliminate hazardous inputs, and simplify logistical requirements, reducing overall costs. Socially, their ease of administration and affordability expand access to advanced therapies, particularly in underserved populations. Economically, MEVs streamline manufacturing and supply chain processes, enabling scalability in emerging markets without imposing significant financial burdens.

Unlike AAVs, MEVs are non-viral, eliminating risks of immune responses. Compared to LNPs, MEVs are naturally stable, biocompatible, and free from toxicity risks, simplifying storage and handling. Furthermore, MEVs surpass mammalian EVs by offering consistent quality at scale. In all cases, MEVs avoid ethical concerns tied to animal-derived materials. These attributes make MEVs a superior alternative for the delivery of therapeutics, vaccines, and gene therapies.

AGS places a strong emphasis on leadership that reflects gender equality and ethnic diversity. Women currently occupy a significant percentage of management roles, with all current positions, except for the current CEO, and future leadership appointments intentionally guided by these principles. This commitment fosters a culture of innovation, inclusivity, and collaboration.

To strengthen its sustainability efforts, AGS is establishing internal guidelines and will soon appoint a dedicated VP of Sustainability. This role will ensure transparency and align initiatives across drug development, manufacturing, and partnerships with both internal and global sustainability goals, embedding sustainability at every level by design.

AGS secures its position as a leader in MEV technology with a robust portfolio of nearly ten patents, and growing, and extensive proprietary know-how. This intellectual property not only protects the company’s innovations but also facilitates their widespread adoption across the industry. By offering a sustainable alternative to synthetic, viral, and animal-based delivery systems, AGS enables the healthcare sector to transition toward more ethical and environmentally responsible practices, underscoring its long-term value to both the industry and society.