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The Road to Commercialization

Antheia’s Chief Operations Officer Zack McGahey offers his perspective on the company’s most recent commercial milestone – a successful full-scale fermentation run of its first product at 116,000L. 

The completion of our recent commercial-scale production run is a tremendous accomplishment for our team and marks a turning point for supply chain challenges that continue to plague the pharma industry. Validating our biomanufacturing platform at this scale is an important step in moving production dependencies away from legacy sourcing to a more reliable, efficient, and agile approach. 

Bringing Antheia’s vision to life has been a complex journey – as any commercialization process is – of experimentation, process development, and layer upon layer of careful decision making. I joined Antheia in November 2021 to lead our transition to manufacturing and this commercial milestone is a huge achievement for Antheia, as well as the synbio industry. 

When I drill down to the core aspects of what made this recent success possible, it comes down to three main elements: building a world-class team, managing stage-appropriate investments, and establishing strong relationships with third-party partners. 

Curating a Purpose-Built Team

Preparing Antheia for its evolution to a commercial-stage company started with building the right team for the job. In the 20+ years that I’ve spent working in manufacturing, I’ve learned that building a world-class operations team is as much about mindset and adaptability as it is experience. Any number of things can (and will) go wrong when bringing a new product to scale and what we’re doing at Antheia has never been done before – so, despite the collective decades of experience within our team, we still face challenges that none of us have encountered before. With every challenge, we have had to evaluate all our possible options, try new approaches, and pivot quickly if it doesn’t work so that we can always move closer toward our goals. 

Our team is unique because we focus less on what we’ve done before that worked, and focus more on what we can do now within our current parameters, timelines, and resources. Being resilient, patient, and agile when attempting something as big as we are doing at Antheia is absolutely critical – and our operations team has intentionally been built around these very principles. 

Over the past few years, I’ve had the pleasure of bringing on some of the best in the industry, including Guerin Kob, our VP of supply chain, Jesse Ahrendt, our SVP of quality assurance & regulatory affairs, and Farrah Pulce, our head of project management. Guerin brings a depth of expertise in managing fermentation-based global supply chains to Antheia and previously led one of the largest bioscience businesses through the COVID-19 pandemic when supply chains were under immense pressure. This is the second time Jesse and I have had the opportunity to work together and I was thrilled to bring him onto Antheia – he brings a holistic approach to developing our quality systems and regulatory processes for both our immediate needs and our long-term goals, and understands the interplay between risk management and quality/regulatory affairs. Finally, the importance of project management cannot be understated – Farrah has been instrumental in ensuring that we maintain our pace and push this project forward every single week, despite the challenges we face on a daily basis.

Our team is unmatched and what we’ve accomplished together thus far – and will continue to accomplish – is nothing short of remarkable. 

Stage-Appropriate Management of Investments 

One of the core tenets of manufacturing that I’ve adopted as part of my professional philosophy is that you have to be relentless in maintaining pace and progress. 

In earlier stages of development, it’s particularly important to be agile and flexible – these are the pivotal moments where you have to invest resources according to your growth trajectory and goals. Antheia’s priority was getting our first product to market rapidly. Sometimes, this means making tough decisions and tradeoffs in efficiency or initial throughput in order to keep progress moving forward and maintaining our aggressive timelines. Now that we have a viable first product, we’re positioned to further develop relationships with future customers, as well as optimize that product to gain throughput efficiencies, which will ultimately benefit the customer. We’re already developing optimizations on the R&D side that will allow us to make efficiency leaps in both time and cost of production. 

With our customers being in the pharma industry, accounting for the long timelines they work in was a huge factor in wanting to get our products to market fast. Introducing our customers to our first product as soon as possible allows us to begin the process for entering their supply chains, all while we continue to bring the rest of our pipeline to market and build up our portfolio of products that we can offer customers. 

But speed doesn’t mean cutting corners. We’ve taken on an enormous lift to meet quality and regulatory standards in a short range of time. Bringing a highly engineered product of this complexity to scale at this speed is a milestone for this industry and we’ve maintained the highest standards for quality and regulatory throughout the entire process. Based on our current progress, our first product will successfully meet all quality and regulatory requirements of all of the necessary regulatory bodies – and our entire pipeline will also be held to the same standards. 

Establishing Trust and Transparency

The third-party partners we work with are also a huge part of bringing our products to market. Two relationships in particular have played a vital role in our success: our CMO (contract manufacturing organization) and the regulating agencies. We’ve been very intentional to establish a company culture around valuing and fostering these relationships. 

Selecting a top-tier CMO partner was critical. They had to meet quality, reliability, and cost parameters, as well as demonstrate a record of quality manufacturing in terms of failure rates and compliance to cGMP and FDA standards. They also had to be able to produce long-term volumes, and accurately develop a path to future business opportunities for its partners. We evaluated a number of technical factors that helped us identify if our processes were compatible with our CMO’s facility. While we expected to make investments in equipment, facilities, and training on our processes, ultimately, both parties had to be confident in the technical ability to achieve the production goals. 

While the technical factors may seem like the most important aspect in choosing a CMO, they are just one element of a broader partnership. In order for any CMO relationship to be fruitful, there has to be a foundation of transparency, open dialogue, and mutual desire for success. Even if all the requisite equipment and capacity is available, we can’t be successful without a CMO that believes in what we’re doing and that we can rely on to meet our goals and timelines. 

We have a similar perspective on our relationships with regulatory agencies. We see them as essential partners in our efforts and they are a linchpin in keeping our pharmaceutical supply chains safe. As a result, we started the discussion with the FDA and DEA as early as possible to introduce them to who we are and what we’re trying to accomplish. Anyone in this industry will tell you about the importance of building open and honest relationships with regulatory agencies and we adopted this as part of our quality and regulatory ethos. 

Building on our Success

I’ve said it already, but it bears repeating: what we’re pursuing at Antheia is unprecedented. The pharma industry is overdue for innovation for how KSMs and APIs are manufactured, and the synbio industry has yet to see a product of this complexity reach commercial scale. 

With our first successful run now under our belt, we’re able to optimize across R&D, manufacturing, operations, and even in our relationships with our third-party partners. The investments that we made to achieve our first manufacturing run will continue to pay dividends well into the future. The flywheel effect that we’ve achieved at the R&D level has now expanded to include our operations and manufacturing efforts. Investments that we make in bringing our first product to commercial scale will increase the speed of our go-to-market efforts across our portfolio of products.

We are incredibly proud to have achieved this first commercial milestone, and we’re excited that it’s also just the beginning. We’re already optimizing our first product, establishing the roadmap for our robust pipeline, and exploring new ways our platform can be applied to bring greater innovation to this market. There is so much more to come – and it holds huge promise for the future of essential medicines. 

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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.