Contact Us
Contact Us
Blog Posts

Addressing a Root Cause of Global Drug Shortages

The years-long journey medicines take from the farm to the pharmacy is a delicate one, vulnerable to extreme weather, mechanical failures, logistical and shipping delays, and geopolitical issues. Supply chain disruptions at any point in the process can cause long-lasting drug shortages that have a major impact on patient care. In fact, there are more than 130 drugs currently in shortage, including essential medicines like the antibiotic amoxicillin for bacterial infections, the chemotherapy drug cisplatin, and the anti-seizure medication diazepam.

To understand and address one of the root causes of these shortages, we’ll zoom in on the international process of drug formulation and manufacturing in simple terms. Specifically, we’ll cover how two key components are combined into finished drug products: active pharmaceutical ingredients (APIs) and excipients, often called inactive ingredients since they do not have a pharmacological effect. We’ll also explore the global impact of essential medicine shortages caused by problems in ingredient manufacturing and supply chains.

Understanding active ingredients

Many people are familiar with the term “active ingredients,” which can be found on the labels of over-the-counter and prescription medications like cold medicine, antibiotics, and topical dermatologic products. These APIs are the chemical components of a drug that deliver the intended biological effect. In other words, they are the reason our medicines work. For example, the active ingredient in Tylenol is acetaminophen, a pain reliever and fever reducer. Examples of APIs used to produce other in-demand medications include naloxone hydrochloride for overdose reversal drug Narcan, and scopolamine for postoperative nausea and motion sickness drugs.

Some APIs are produced from Key Starting Materials (KSMs), many of which are sourced directly from nature and specifically, plants (for more on the long history of KSMs, see here). However, plant-derived ingredients are vulnerable to external variables like climate crises, growing seasons, and soil health, which can lead to drug shortages with lasting effects. The agricultural process is also resource-intensive, requiring large amounts of land, water, and chemicals like pesticides. Since it takes several years to grow, harvest, extract, and process medicinal crops, yields and volumes are determined years in advance, and there is no practical way to increase supply when there are shortages or sudden changes in demand.

Without a steady and predictable supply of KSMs and APIs, pharmaceutical supply chains can quickly break down, leaving healthcare systems without the essential medicines they need to treat patients. Physicians face impossible decisions, such as delaying or abandoning treatment plans, and managing shortages can cost hospitals hundreds of thousands of dollars annually.

The pharma industry, healthcare systems, and patients alike need a new mode of drug manufacturing that can support the dynamic needs of a growing global society. By reducing our reliance on costly, inefficient, and unreliable agricultural processes, we can ensure that people have access to the medicines they need.

The role of excipients

APIs are the most critical elements of our finished drug products, but they typically aren’t administered to patients in their native forms. During the drug-making process, manufacturers combine APIs with other materials — excipients — to produce medications in the forms of pills, injections, or topicals. Excipients are listed alongside active ingredients on drug labels and while they don’t have a direct pharmacological effect, they play an important role in stabilizing, administering, accepting, and increasing bioavailability of the API.

Excipients serve many different functions in a drug formulation, including improving drug stability and controlling when and where the active ingredient is released into the body. During the formulation process, drugmakers combine APIs and excipients to meet patients’ dosage and administration needs. Any disruption to the production of these two critical components could delay the rest of the manufacturing process, which in turn impacts the rest of a drug’s journey to hospitals, pharmacies, and doctors’ offices around the world.

In summary, while KSMs and APIs are the linchpins that make drugs work, there must also be a consistent, high-quality supply of common excipients to avoid wider drug shortages.

An international problem

Drug shortages and efforts to counter them are well-documented in countries with high-income economies like the U.S. and throughout the EU, but the problem goes far beyond those borders. In fact, the WHO estimates that over two billion people worldwide lack access to basic medicines. In a study of drug shortages in Colombia from 2010 to 2021, researchers found 173 drugs in shortage, lasting an average of 1.6 years. The longest shortage was for naloxone tablets, a life-saving overdose reversal medication, lasting nearly 10 years. The most common causes of these shortages were manufacturing issues and a small number of suppliers in the market unable to match demand.

Many of these issues stem from the global nature of pharmaceutical supply chains and our widespread dependency on only a few countries for these critical ingredients. Advanced manufacturing technologies, such as synthetic biology and biomanufacturing, can enable efficient, on-demand, and rapid response pharma production that can be globally distributed to diversify and localize where KSMs and APIs are produced. Biomanufacturing has the potential to not only end drug shortages but also bring essential medicines to countries that have historically had little to no access to these life-saving drugs.

Addressing a key root cause

The global and complex nature of the pharmaceutical industry means there are many opportunities for the supply chain to be disrupted. No one company or organization can prevent every problem in this fragile system, but biomanufacturing is the first technology that offers a step change that can truly transform these vital supply chains for essential medicines around the world. We estimate that more than 50 percent of medicines on the U.S. FDA Essential Medicines List can be made with biomanufacturing technology in weeks – rather than years – and at a fraction of the cost of conventional manufacturing approaches.

A 2023 study found that raw material availability and manufacturing issues make up at least 14 percent of shortages. Antheia is directly addressing these issues, replacing legacy agriculture-based processes with biomanufacturing for more resilient, agile, and efficient pharma supply chains.

With cutting edge science, innovative biomanufacturing processes, and strong industry partnerships, we’re building the next generation of global pharmaceutical supply chains and enabling the industry to produce and deliver essential medicines to the people who need them most.

Follow Antheia on LinkedIn and X/Twitter.

Richard Sherwin

Head of Commercialization

Richard is an industry veteran with more than 30 years of experience in the KSM, API, and intermediate markets. He is responsible for leading the commercialization and revenue generation for Antheia’s robust pipeline of products. Richard brings an exceptional track record of leading international sales teams, driving revenue growth, building strategic partnerships, and delivering innovative products to market, including ANDA and NDA developments. Richard led commercial efforts at some of the leading global pharmaceutical companies and most recently, built his own consultancy business advising a range of clients, including $1B divisions of major multinationals.

Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.

Yihui Zhu, PhD

Head of Fermentation

Yihui leads the fermentation team at Antheia. With over 25 years of hands-on experience in the field, he brings in-depth knowledge and expertise in microbial metabolism and fermentation process development. He is also skilled in developing comprehensive fermentation data collection, analysis, and visualization systems. Prior to joining Antheia, he served as a fermentation lead at Intrexon and Codexis where he successfully built fermentation labs and teams and led multiple biofuel and biochemical projects to reach stretch milestones and tech transfer. Yihui is passionate about the potential of fermentation and is dedicated to advancing the field through innovative research and development.

Yen-Hsiang Wang, PhD

Head of Strategy, Partnerships, and Finance

Yen-Hsiang leads strategy, partnerships and finance at Antheia. He completed his M.S. and Ph.D. in Bioengineering at Stanford, with extensive research experience in synthetic biology, metabolic engineering and computational modeling. Before joining Antheia, he worked at McKinsey and Tencent with a strong focus in corporate strategy and big data/advanced analytics. At Tencent, he served as Director of Strategy and Business Development for the AI Lab, leading corporate initiatives in healthcare AI/ML applications and commercialization. He also served in AI4H (Artificial Intelligence for Health), a collaboration between WHO and ITU, to establish global standards for AI in healthcare.

Audrey Wang

Head of Financial Planning and Analysis

Audrey leads financial planning and analysis at Antheia. With an MBA from Washington University in St. Louis, Audrey is passionate about leveraging financial analysis, digital technology, and data analytics to guide companies in making optimal investments and strategic business decisions. Audrey has a decade of experience in helping companies solve unique problems and creating long-term impact with unconventional approaches. Before joining Antheia, she was at Vir Biotechnology and Merck where she led various FP&A workstreams, including investment valuation, asset prioritization, and manufacturing sites operation finance support. Audrey completed CFA Level II and passed the U.S. CPA exam in 2011.

Antonij Tjahjadi, CPA

Head of Accounting

Antonij Tjahjadi leads accounting at Antheia and holds active CPA license. He joined Antheia with more than 20 years of experience in corporate accounting, bringing deep expertise in ramping up accounting operations for start-up companies, SEC reporting/technical accounting, and SOX implementation efforts. Before joining Antheia, he held various leading roles in both public and private company settings, including directing accounting functions at Ambys Medicines, where he successfully implemented Netsuite with Point Purchasing integration and set up various accounting policies and processes, and played a key role in the initial public offering of Nutanix, Inc.

Ken Takeoka

Head of Biology

Ken leads the Biology team at Antheia, which incorporates both strain and protein engineering functions. He has more than 16 years of experience in the synthetic biology field, working with leading companies, including Amyris and Novartis. One of his passions is molecular biology tool development and he previously worked to build the foundation for the automated strain engineering pipeline at Amyris. At Novartis, he modernized the molecular biology techniques and established a platform to model mechanisms of antibiotic resistance in a range of organisms.

Suzanne Sato

Head of Downstream Processing

Suzy leads downstream chemistry processes at Antheia. She has 19 years of experience in process development, including route development through synthetic chemistry and scale-up of small molecule APIs for GPCR targets under cGMP for Phase I-III trials. Before joining Antheia, Suzy led a full DSP team at Amyris where she successfully pivoted developments from biofuels hydrocarbon products to pharmaceutical intermediate, flavor, fragrance and nutraceutical products. She led a team that scaled 11 products and took five products to commercial manufacturing.

Farrah Pulce, PMP

Head of Project Management

Farrah leads program and project management at Antheia. She has over 20 years of experience leading program and project management, operations, and engineering for companies across the CPG, aerospace, and automotive industries. Prior to joining Antheia, Farrah implemented and led the sustaining program management team at Impossible Foods. She also led product operations, project management, and cost optimization at Blue Bottle Coffee and Tyson Foods to develop and commercialize new products. As a certified project management professional (PMP), Farrah has a proven record of successful project delivery, improving project management practices, and building collaborative teams.

Jordyn Lee

Head of Communications

Jordyn leads communications and external affairs at Antheia. She brings a decade of multidisciplinary communications experience in helping companies make complex science and technology accessible to broad audiences, all while maintaining technical accuracy and integrity. She has a passion for visionary storytelling and translating impact across the entire communications ecosystem – her work has spanned from public relations to corporate communications to marketing. Jordyn has served as an advisor to a number of different life sciences companies and most recently led corporate communications at Amyris.

Ben Kotopka, PhD

Head of Data Science

As Head of Data Science at Antheia, Ben manages in-house software development and external partnerships for storing and interpreting research data, executing bioinformatics analyses, and streamlining business processes. Prior to Antheia, Ben worked as an academic researcher at the intersection of machine learning, bioinformatics, and synthetic biology. Following this, as an entrepreneur and consultant, he developed and deployed data science solutions for biotechnology applications ranging from metabolomics-driven compound discovery to MRI segmentation.

Guerin Kob

Head of Supply Chain

Guerin is responsible for leading the design, development, management and improvement of Antheia’s end-to-end global supply chain. He has over 15 years of experience leading high-performing supply chain and procurement teams at leading biotechnology and specialty chemical companies, with extensive experience in process development and end-to-end supply chain optimization. Prior to joining Antheia, Guerin served as Senior Director of Global Supply Chain for Sumitomo Chemical’s biotechnology division with Valent Biosciences, where he led the end-to end supply chain including procurement, logistics and distribution, integrated business planning, materials management, customer service, and supply planning functions globally.

Pavel Aronov, PhD

Head of Bioanalytics

Pavel leads the Bioanalytics team at Antheia. He has 20 years of experience in analytical and clinical chemistry, mass spectrometry, chromatography, and metabolomics. Pavel built and led the original Chemistry and Analytics team at Impossible Foods enabling strain development, fermentation, DSP, regulatory, QC, and scale-up of leghemoglobin biomanufacturing. During his academic career at UC Davis and Stanford University Pavel developed a vitamin D assay used by all major clinical diagnostics laboratories and pioneered metabolomics studies to investigate kidney disease and microbiome.

Jesse Ahrendt

Head of Quality Assurance and Regulatory Affairs

Jesse has more than 25 years of experience in regulatory affairs, quality systems, manufacturing quality, and regulated industries, ranging from early- to late-stage pharmaceuticals, biomanufacturing, consumer care, and medical devices. He has supported global product launches and the underlying quality supply chain components in industries that require strict adherence to internationally accepted quality standards. Before Antheia, he led quality efforts at Zymergen and Sandoz, and supported many global pharmaceutical companies during his time in Biotech Consulting at NSF International, all to bring quality to the forefront in manufacturing, standardize global processes, and support customer regulatory requirements.

Heidi Pucel

Chief People Officer

Heidi is a results-driven human resources executive and HR business partner who leverages decades of experience in empowering, motivating, and inspiring to drive transformation within high-performing and rapidly-growing workforces. A certified executive coach and passionate advocate for people-oriented solutions, Pucel serves as a partner to executive teams to design programs that support employee development, engagement, and recruitment and retention. Pucel most recently served as Chief People Officer for Countsy, where she worked as an interim HR executive for clients in the biotechnology and software industries, such as Ceribell and Tune Therapeutics.

Zack McGahey

Chief Operating Officer

Zack is a leading executive in operations management, specializing in bioprocess engineering and manufacturing management. He has over 20 years of experience leading manufacturing functions for companies across the pharmaceutical, synthetic biology, diagnostics, and automotive industries. Before joining Antheia, Zack was VP of manufacturing and capex project management at Zymergen. He also gained experience managing commercial scale facilities operations for Tesla, where he was responsible for managing 10 million square feet of factory, lab and warehouse space during the Model 3 ramp.

Kristy Hawkins, PhD

Co-Founder & CSO

Kristy has over 20 years of experience in the field of synthetic biology, focusing on yeast metabolic engineering for the production of small molecules. She did the founding work on the benzylisoquinoline alkaloid pathway during her graduate studies and gained valuable industry experience at Amyris and Lygos. Kristy is an expert in tool development, high-throughput screening, and host strain and heterologous pathway engineering.

Christina Smolke, PhD

Co-Founder & CEO

Christina is a pioneer in synthetic biology and metabolic engineering, where she has over 20 years of experience. As Professor of Bioengineering and Chemical Engineering at Stanford University, her laboratory led the breakthrough research to engineer baker’s yeast to produce some of the most complex and valuable medicines known. Under her leadership, Antheia’s synthetic biology platform enables new possibilities for drug discovery and efficient, sustainable, transparent, and on-demand drug manufacturing at scale. Her vision and accomplishments have garnered numerous awards, including the Chan-Zuckerberg Biohub Investigator, NIH Director’s Pioneer Award, Nature’s 10, Novozymes Award for Excellence in Biochemical Engineering, and TR35 Award.

U.S. Secretary of State Antony J. Blinken visits Antheia to discuss biotechnology innovation

Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.