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 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.
PharmaSource: Antheia and Olon Extend Biomanufacturing Partnership
Antheia and Olon have announced a continuation of partnership, leveraging Olon’s fermentation infrastructure for the manufacture of Antheia’s early products
Antheia and Olon Continue Partnership for Biomanufacturing Antheia’s Pipeline of KSMs and APIs for Essential Medicines
Antheia and Olon established this partnership in 2022 to leverage Olon’s fermentation sites across Italy. Olon has since played a pivotal role as a CDMO for scaling Antheia’s biomanufacturing processes and producing its Biosynthetic KSMs (key starting materials) and APIs.
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
Forbes Sustainability Leaders Summit: Antheia’s CEO on Transforming Supply Chains
Antheia joined some of the industry’s most notable thought leaders at the prestigious Forbes Sustainability Leaders Summit, which gathered on September 20 in New York City to discuss insights, innovations, and visions for a more sustainable future.
Addressing the Drug Shortage Crisis: Transforming Pharma Supply Chains
Drug shortages in the U.S. have become an urgent issue over the last few years. So much so that in 2020, the Administration issued an Executive Order for the U.S. FDA to establish an Essential Medicines List of critical drugs that are deemed medically necessary, with the ultimate goal of identifying ways to protect and provide for the American public’s undisrupted access to these essential medicines. Ultimately, pharmaceutical supply deficits have continued to plague U.S. healthcare systems, with cancer drug shortages being the latest impacting patients. Oncology drug shortages in particular carry dire consequences for cancer patients given the urgency of treatments, leaving many with limited care options. Simultaneously, healthcare providers are being forced to make extraordinarily difficult decisions with the drugs they do have, rationing doses or delaying care in order to balance the needs of their patients with limited supplies. Compromising care and treatments leaves doctors and patients alike in a no-win situation – and one that shouldn’t have happened in the first place. Unsurprisingly, recent shortages have sparked many healthcare professional and patient groups to ask Congress to intervene, leading to the recent introduction of the Pharmaceutical Supply Chain Risk Assessment Act. We believe it will be one of many policy efforts to seek solutions, as public discourse continues to build regarding the extreme lengths individuals have gone to secure life-saving medicines. While the request is simple – generate more supplies, and quickly – the solution is not. Pharmaceutical supply chains are extremely complex and face many factors that are easily disrupted and can quickly trigger a drug shortage, including natural disasters, climate change, geopolitical events, and manufacturing facility issues, to name a few. These ever-growing threats and challenges continue to add pressure to the urgent need for innovative and nimble solutions to optimize pharma supply chains, and ensure that the public has reliable access to all critical, essential medications. Antheia was founded in 2015 to address the threat of drug shortages through agile biomanufacturing techniques, and we have witnessed the urgency of realizing our mission with each passing year. Currently, we are working to bring a robust pipeline of Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs) – the critical components of a medicine that produce the intended effect – to market, across a wide variety of therapeutic areas, including oncology, as well as neurology, respiratory, anti-infective, gastrointestinal, endocrinology, and hematology. Our platform and pipeline are intentionally designed to ensure reliable, consistent, and equitable access to critical drugs, to avert supply disasters by decoupling KSM and API production from current agricultural sourcing, and over time, make drug shortages a problem of the past. Biomanufacturing has the power to transform pharmaceutical supply chains. By leveraging engineered yeast and fermentation-based manufacturing processes that can be activated quickly, on-demand, and potentially anywhere in the world, we can ensure that patients and providers have reliable access to critical medicines. The cancer drug crisis we’re experiencing right now is not the first, but it could be the last if we systematically transform our pharmaceutical supply chains and invest in advanced biomanufacturing technologies. Follow Antheia on LinkedIn and Twitter.
Antheia at SynBioBeta: Leveraging Synthetic Biology to End Drug Shortages
Antheia was a proud sponsor of this year’s Global Synthetic Biology Conference, and participated in two high impact talks designed to share our progress toward transforming pharmaceutical supply chains.
