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Investing in the next wave of biomanufacturing technologies for pharma

The global pandemic has brought pharmaceutical manufacturing to the forefront of America’s public consciousness. Acute drug shortages brought on by COVID-19 have underscored the need for domestic production and more resilient supply chains. Federal agencies and private industry are pushing for technologies that will modernize how medicines get made.

Continuous manufacturing, in particular, is gaining attention and increased investment. Compared to legacy batch processes, a continuous approach is faster, more cost-effective, and can respond to sudden changes in demand.

The shift to continuous manufacturing is a boon for the industry and public health overall, but is not applicable to all drugs. It represents a significant improvement for a subset of medicines: chemically synthesized small molecule drugs. The future is unclear for drugs outside of this category, including plant-derived pharmaceuticals, which make up nearly 40% of medicines.

It is time to modernize manufacturing for a broader set of small molecules. Next-generation biomanufacturing—an approach based on synthetic biology and microbial fermentation—is ready to be scaled as a manufacturing technology. It promises to build a more resilient and nimble supply chain for essential drugs.

Below, we review the manufacturing methods used today and propose an evolution.

Traditional approach: Batch manufacturing

What it is: For the past fifty years, batch production has been the standard for making small molecule drugs. It involves manufacturing a specific quantity (batch) through a series of discrete steps, including synthesis, crystallization, blending, granulation, and tablet coating. Production stops after each step, and raw material moves to the next machine or facility.

Benefits: The equipment, workflows, and regulation surrounding batch manufacturing are well established; pharma companies have already invested in batch machinery and facilities for thousands of drugs. For batch production, drugmakers can often leverage existing equipment. It requires relatively simple machinery, which tends to be easier to operate, maintain, and troubleshoot.

Challenges and limitations: The batch approach is more time-intensive and requires higher operational costs because of the multiple steps and facilities involved. Production is often distributed across multiple countries which adds time, complexity, and the need to coordinate storage. Batch manufacturing requires large-scale equipment and significant physical space, so it has a larger environmental footprint than other advanced manufacturing processes.

Another limitation of batch manufacturing is that it is not agile. Production volume is set at the beginning of the process; there is no room to dial it up or down based on spikes or dips in demand.

Advanced manufacturing approach:

1. Continuous manufacturing

What it is: Continuous manufacturing functions like a constantly running assembly line, turning raw materials into small molecule drugs without pausing after each step. It operates in a single facility, which streamlines production.

Benefits: The most significant benefits are time and cost savings—continuous manufacturing can save weeks or months and millions of dollars because there is no waiting for material to be transported, sampled, and stored.

Quality is also built into the process. The material can be tracked at a more granular level, which allows drug-makers to isolate quality issues.

Continuous production can ramp up quickly, making it more responsive to demand changes and more flexible overall. The assembly line can run for a longer period to produce a higher volume.

Challenges and limitations: The “always-on” nature of continuous manufacturing means that maintaining machinery is disruptive—for example, malfunctions in one part of the system can shut down operations overall. The integrated nature of the process means that it requires a significant upfront investment in equipment.

Despite its clear benefits and the FDA’s encouragement, adoption remains limited. Pharma companies have already invested many millions of dollars in batch processing facilities. Reporting by STAT found that just a handful of pharmaceutical companies in the U.S. have moved to continuous processes, and only for a limited number of new drugs.

Current discussions about batch vs. continuous manufacturing acknowledge these benefits and challenges, but they exclude an essential consideration. Continuous manufacturing does not provide access to new chemical space or produce new types of compounds. The problem of manufacturing plant-based medicines at scale remains. Even if the U.S. were to transition entirely to continuous manufacturing, we would still be vulnerable to critical shortages of life-saving drugs.

2. Biomanufacturing

What it is: Biomanufacturing is the process of producing desired molecules using microbial hosts such as yeast or bacteria. Through fermentation, these microbes operate as living factories to manufacture small molecule drugs at scale.

Now, with advances in synthetic biology, it’s possible to clone genes from plants and express single enzymes and even entire pathways in yeast. Our team at Antheia has engineered yeast cells to manufacture plant-based drugs, including tropane alkaloids, which occur naturally in the nightshade plant and are used to treat Parkinson’s and other conditions.

Benefits: A biology-based manufacturing platform can make medicines that are not accessible through chemical synthesis. Biomanufacturing is the only viable alternative to growing and harvesting medicinal plants, which present significant supply chain challenges.

Synthetic biology opens up the potential to develop drugs in underrepresented chemical space. With a syn-bio-based manufacturing platform, it is possible to address biological targets that are currently considered “undruggable.”

Challenges and limitations: Biomanufacturing has only been applied to small molecule drugs relatively recently. The typical question raised in the industry is whether the technology is ready to be commercialized and scaled. Our recent progress has affirmed this readiness; scaling is not a far-off reality.

Scaling biomanufacturing technologies

Biomanufacturing already produces commercial quantities of small molecules ranging from fragrances (e.g., rose oil) to food-grade products (e.g., sweeteners including Reb M, aka Stevia) to cannabinoids (e.g., CBD). There is existing infrastructure that can be expanded or repurposed to make pharmaceuticals.

Pharma applications are far from new; insulin, antibiotics such as penicillin, and protein therapeutics are all commonly manufactured via microbes today.

These pharma applications also include plant-based drugs manufactured using fermentation. Amyris developed strains that Sanofi used to produce up to 20 metric tons of artemisinin, an antimalarial naturally derived from the sweet wormwood plant. Now Manus Bio is exploring a lower-cost solution using its E. coli platform.

At Antheia, we are engineering yeast cells to manufacture plant-based pharmaceuticals at scale: recent pilot runs reached commercially relevant titers. We are confident that biomanufacturing will soon produce a broad range of medicines: chemotherapeutics, anticholinergics, anesthetics, and many others that are now sourced from plants.

Advancing pharma manufacturing for all medicines

Solving America’s most urgent drug supply problems requires investment in a variety of advanced manufacturing technologies. Biomanufacturing is a powerful, proven platform and a complement to continuous manufacturing. Together, these technologies represent a critical step toward building resilient drug supply chains, and ensuring that patients have access to essential medicines when they are most in need.

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.