Antheia Announces New Funding to Support Domestic Production of Critical Pharmaceutical Ingredients
Company awarded government project agreement to onshore key pharmaceutical supply chains, alongside strategic investment from In-Q-Tel and Echo
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.
Antheia at SynBioBeta 2024: Scaling Highly Engineered Strains
Antheia was a proud sponsor of this year’s SynBioBeta, the Global Synthetic Biology Conference hosted annually in the San Francisco Bay Area.
Introducing Pavel Aronov, Senior Director, Bioanalytics
Pavel and his team have developed the processes to accurately measure the quantity of our biosynthetic KSMs and APIs produced via biomanufacturing, which is no small feat when working with biological products
U.S. Secretary of State Antony J. Blinken Visits Antheia to Discuss Biotechnology Innovation
In early May, U.S. Secretary of State Antony J. Blinken visited Antheia, HQ in Menlo Park, California for a tour of our labs and a panel discussion with innovators in the biotechnology industry
Secretary of State Antony J. Blinken Tours Antheia, Discusses the Importance of Biotechnology Innovation in the United States
Visit demonstrates U.S. commitment to bolstering the domestic biotechnology industry and onshoring critical supply chains, including pharmaceuticals Menlo Park, Calif., May 6, 2024 – Antheia, the pharmaceutical ingredient manufacturer transforming essential medicine supply chains, today hosted Secretary of State Antony J. Blinken for a tour of its state of the art labs, as well as a discussion on biotechnology innovation and leadership in the United States. During his visit, Secretary Blinken met with a panel of industry and policy experts from Atomic AI, Ginkgo Bioworks, MycoWorks, Stanford University, and Twist Bioscience. The discussion was moderated by Christina Smolke, Ph.D., CEO and co-founder at Antheia and focused on the critical role of biotechnology to U.S. national and economic security, the need for strong international partnerships to develop solutions for global good, and the urgency to maintain U.S. leadership in this critical emerging technology. “We are grateful to Secretary Blinken for his time and attention today, as well as the U.S. government’s continued commitment to advancing biotechnology and biomanufacturing,” said Dr. Smolke, CEO and co-founder, Antheia. “With the ongoing support of both the public and private sectors, a future with resilient, sustainable pharmaceutical supply chains, minimal disruptions to critical drug supplies, and equitable access to essential medicines for all is well-within reach.” On September 12, 2022, President Biden issued Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” According to the White House, “global industry is on the cusp of an industrial revolution powered by biotechnology.” As part of the scope of the biomanufacturing executive order, the Department of State is working to promote and protect U.S. technologies and the global bioeconomy. By Antheia’s estimates, advanced biomanufacturing can enable domestic production of over 50 percent of the key starting materials (KSMs) and active pharmaceutical ingredients (APIs) underlying essential medicines at a fraction of the time and cost of conventional manufacturing. Antheia’s first product, thebaine, is a key ingredient used in the production of several drugs on the U.S. Food and Drug Administration and the World Health Organization’s Essential Medicines lists. Antheia’s processes have been validated at scale, demonstrating this technology’s viability, commercial-readiness, and societal impact. About AntheiaAntheia is the next-generation pharmaceutical ingredient producer transforming essential medicine supply chains to end drug shortages. Using its novel whole-cell engineering approach, Antheia’s biomanufacturing platform enables the reconstruction of biosynthetic pathways of unprecedented complexity in yeast cells and the scaling of fermentation processes to commercial levels. This highly flexible approach enables on-demand, agile, and resilient biomanufacturing of critical pharmaceutical ingredients, replacing legacy approaches that cannot support the needs of modern healthcare. For more information, visit www.antheia.bio. MEDIA CONTACT: Mission North for [email protected]
Antheia CEO Keynotes at OECD Global Forum on Technology: Building our Bio Future
Last week, Antheia CEO and co-founder, Dr. Christina Smolke joined OECD’s Global Forum on Technology: Building our Bio Future as a keynote speaker. OECD (Organization for Economic Co-operation and Development) is an international organization bringing together government, academia, and industry to build global policies that foster prosperity and well-being for all. In her keynote address, Dr. Smolke discussed the transformative power of synthetic biology, its role in solving major challenges across industries including pharma supply chains, and how policy can support a flourishing synthetic biology industry. This forum brought together some of the brightest minds across the synthetic biology field from around the world. A recurring theme from the event’s discussions, both on- and off-stage, was the need to align stakeholders from all aspects of this international industry. The urgency to develop sustainable manufacturing solutions is rapidly increasing as natural resources are depleted and supply chains repeatedly falter. The global population is at risk of failing supply chains, but with a coordinated effort between industry, academia, government – specifically, policy, governance, and regulation – synthetic biology has the potential to fundamentally transform these legacy systems to better support the public at large. As a pioneer in the field of synthetic biology with more than 20 years of experience, Dr. Smolke offered a unique perspective on the evolution of this technology and its current role as an advanced manufacturing technology for critical pharmaceutical ingredients. Pharma is one of the most vital global supply chains, but it is also one of the most fragile and unreliable, with serious consequences (e.g. drug shortages, inadequate patient care) for human health when something goes awry. Synthetic biology offers an innovative solution to build resilient, agile, and sustainable supply chains for pharma, as well as other critical industries like food, agriculture, and industrial materials. As a global community, countries need to consider how to support and incentivize the advancement of synthetic biology to unlock benefits for all people and the planet. This could take the shape of public-private partnerships, funding, or policies that provide incentives to bring these innovative solutions to global markets. Synthetic biology is a powerful technology for solving major, global problems and is on the precipice of reaching its full potential. With the right policy, support, and prioritization from leaders like those present at OECD’s Global Forum on Technology event, we will continue to see growth and transformation stemming from synthetic biology innovation. Follow Antheia on LinkedIn and X/Twitter.
Future of Pharma Insights: Q&A with Olon Group
We sat down with Andrea Conforto, VP of CDMO at Olon Biotech.
Introducing Walter Tamulis, Senior Staff Engineer, MSAT
Antheia’s recent commercial breakthrough required the effort of many technical experts who contributed countless hours of hard work. In today’s blog, we are pleased to introduce Walter Tamulis, Senior Staff Engineer of MSAT, a key member of the operations team who was essential in executing our first 116,000L scale run of thebaine and subsequent validation runs. We sat down to speak with Walter to ask him about his background and what inspires him at Antheia: You bring a wealth of experience in pharma manufacturing to the team, from pilot scale to commercial scale manufacturing. For those who don’t know you, let’s start with you telling us a little about yourself and your background. I studied molecular biology at the lab bench in graduate school, but my first industry experience was actually in large scale manufacturing of monoclonal antibodies for Genentech. That’s where I started growing a passion for the science of manufacturing and scale up, which has endured across my 17 years in bioprocess industries. From manufacturing pharmaceutical biologics with Genentech, I moved on to developing advanced biofuels technologies with BP and DuPont, industrializing enzyme production processes with BASF, and more recently, scaling-up precision fermentation with Zymergen. Now, I am enabling the commercialization of cutting-edge synthetic biology technologies with Antheia. My experience has really been about straddling different scales of technology with different teams and tech transferring processes within and across companies, including owned and operated facilities and contract manufacturers. I’ve always loved seeing things happen for the first time on a large scale, and at Antheia, I do just that – working with the right partners, facilities, and technologies to ensure the scaleup and manufacturability of our products is feasible. What made you say “yes” to Antheia initially and what inspires you about the work you do here? I was introduced to Antheia by Zack McGahey, our COO whom I had worked with previously at Zymergen. As soon as we had our first conversation about Antheia, I really understood the power of the technology and the potential it holds for sustainable and renewable manufacturing. I found that incredibly inspiring and I was immediately interested by the opportunity to both apply my experience in the industry and work on something that is meaningful to me on a personal level, since I believe that sustainability and renewability in manufacturing is one of the most dynamic things we can do to work within our resource constraints while improving our planet. When I reconnected with Zack, the technology had just matured and was ready to move into commercial production, so I was fortunate to join right as the operations team was beginning to ramp up. Once I had a chance to meet the team, I was really sold by the work ethic, scientific excellence, and focus shared by the entire company – it was an easy decision. Since then, I’ve been a part of that critical moment where the rubber hits the road as we actively commercialize our first products. It’s been an exciting time to be a part of this team. We know you’ve had an incredibly busy season – can you share what your work looks like, as the rubber has hit the road, so to speak? My work is pretty project based, focusing on the target product that we’re working on at any given point. Now that Antheia’s first product, thebaine, has debuted, we are hard at work on moving our second and third products to commercial scale while our R&D team continues to develop and progress products that are still moving through our pipeline. These products are in various stages of development and commercialization, which means my role is overseeing the transfer of those technologies – at any stage they’re in, whether that be pilot, demonstration, or commercial – to our external sites, currently both abroad for commercial and in the U.S. for some of our pilot-scale operations. In addition to our commercial and customer engagement efforts, these tech transfers and scaled runs are critical to our forward momentum as a KSM and API producer. It’s exciting to be part of this progress as we move toward validating our product with customers and passing the final hurdles with regulatory bodies. In terms of my day-to-day, I spend a lot of time at these partner sites, working closely with our third-party manufacturing teams and liaising between Antheia’s R&D, operations, and commercial teams. One week I may be evaluating a potential facility in anticipation of scale-up and commercialization and the next week I’m supporting the execution of commercial production runs at an established partner. These are tangible, on-site projects with capital expenditures that require up-close monitoring to ensure functionality, which means that I’m constantly collaborating with people at manufacturing sites all over the world. The first successful commercial run of thebaine was a massive milestone for Antheia and then shortly after, Antheia completed its validation campaign. These were huge feats for the operations team, and you specifically spent a lot of time with our partner in Europe to make that happen. Can you share more about that experience? Absolutely. From an engineering perspective, quite a few complex capital expenditure (CAPEX) projects were required at our partner contract manufacturing organization (CMO) to enable these first manufactured batches of thebaine. In the 12 months leading up to actual execution, we had to design, order, install, and commission equipment while working closely with the CMO engineering team to ensure on-time delivery and to meet all operational and safety requirements. We also identified projects to increase efficiency and reduce operational costs, alongside modeling the techno-economics of our processes. During the execution of our first commercial validation runs, I represented Antheia at our CMO as our person-in-plant. In this role, I helped maintain timelines and ensure that Antheia’s expectations of operational execution, equipment reliability, and product quality were met. I was the eyes and ears for Antheia onsite at our CMO for weeks and months at a time, and it meant wearing multiple hats, monitoring
Antheia Completes Successful Product Validation
Company’s first full-scale fermentation run reinforces commercial viability for a robust pipeline of Biosynthetic KSMS and APIs
