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
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’s 2023 in Review: A Year Of Transformation
Dear colleagues, friends, and supporters: As we approach 2024, we want to take a moment to look back over an absolutely astounding year of progress for our business and give thanks to the many who made it possible. Nearly a decade of hard work culminated in an industry-first achievement here at Antheia. In August, we announced our first successful commercial-scale fermentation run of our debut product, thebaine. For Antheia, it represented a moment in our history where an entirely new model for pharmaceutical supply chains was proven viable. This achievement also marked an industry inflection point, heralding a new frontier of scalable biomanufacturing of highly engineered microbial organisms with 25-30 complex, heterologous biosynthetic steps and more than 20 enzymes. Over this past decade, we’ve taken this scientific innovation from theory, to lab bench, to viable commercial production. With this year’s debut of our first products in a pipeline of 70+ key starting materials (KSMs) and active pharmaceutical ingredients (APIs), we’ve only just scratched the surface of what’s possible in terms of using this platform to produce critical pharma ingredients for essential medicines. As early pioneers in this field and stewards of this proven and scaled technology, our determination to bring this biomanufacturing solution to the world has only grown with this year’s progress. The need and urgency for this solution persists; this year the healthcare industry faced relentless shortages in critical drug classes, including central nervous system therapies, antimicrobials, fluids/electrolytes, hormones, and chemotherapies, while the pharmaceutical industry continued to struggle to resolve these shortages in a timely and effective manner. Over the past five years, we’ve seen the occurrence of new molecule shortages triple, with a striking 84% of the drugs in shortage being generics. Combined with the persistence of up to 50 new drug shortages annually and an average shortage duration of 1.5 years, pharma supply chains underpin a dire situation in healthcare that demands immediate attention and comprehensive resolution. Fortunately, we see a brighter future. Our estimates show that more than 50% of the drugs on the U.S. FDA Essential Medicines list can be made via biomanufacturing technology. With this reality now within reach more than ever before, the U.S. – and more broadly, the world – is quickly realizing the potential of synthetic biology as an advanced, and much-needed manufacturing solution. Just this year, we were proud to contribute to The National Action Plan for U.S. Leadership in Biotechnology. The plan outlines a series of policy recommendations with the end goal being an “agile, rapidly-scalable, distributed biomanufacturing base that efficiently produces the majority of essential medicines and makes affordable medicines available to everyone who needs them.” As further legislative efforts have – and continue to – emerge, we are encouraged to see the industry and the U.S. government moving in the same direction, toward the same shared goal: to capture the full potential of synthetic biology and unlock solutions that will materially improve the availability and supply chains of essential medicines. As we approach 2024 and this next chapter of our business, we want to take a moment to recognize what truly makes Antheia so great. It isn’t just the continued scientific innovation or our operational development that makes 2023 such an impressive year of transformation, but the phenomenal team of people behind it. We believe in a world where patient care and health equity are never jeopardized by global pharma supply chain vulnerabilities, and our growth would not have been possible without the exceptional colleagues that are dedicated to this mission each and every day. Our wins this year, and our success next year and beyond, are thanks to our team and our many supporters – we look forward to another big year as we advance our commercial strategy in 2024. Cheers, Christina Smolke, PhD | CEO and Co-Founder Kristy Hawkins, PhD | CSO and Co-Founder
Introducing Suzanne Sato, Antheia’s Head of Downstream Processing
As the Head of Downstream Processing, Suzanne Sato leverages her 19 years of experience to lead downstream chemistry processes at Antheia. Her ability to keep the big picture in focus while working collaboratively with various teams is central to the success of Antheia’s mission. Suzy recently sat down for a Q&A in which she shares her insights on the challenges and opportunities that arise when bridging the gap between research, commercial production, and downstream processing in the biomanufacturing industry, as well as the team dynamics that make success possible. Q: Tell us a little bit about your background, and how you came to Antheia? I originally planned on teaching science, but while I was getting my degree in chemistry, I ended up doing two years of research on inorganic chemistry and got bit by the research bug. I discovered I really enjoyed the hands-on work and problem solving that comes with research, and knew that I just had to get a job in the industry. In research, you rely on a lot of things you’ve learned, but you have to adapt and apply it differently most of the time, which means you have to get pretty clever and creative. What drew me to the synbio field specifically was the opportunity to do something sustainable that could truly compete with fossil fuels-based chemistry. For my first job in the industry, I was lucky enough to work for a company called Arena Pharmaceuticals that had its own pilot plant producing active pharmaceutical ingredients (APIs). While at Arena, I worked in chemical synthesis, which provided my foundation for process development with training from chemical engineers and process chemists. I gained hands-on experience with developing chemical routes for scalable processes. This is not as simple as just performing the same chemistry on a larger scale. You have to take into consideration the costs, yields, and cycle times and most manufacturing processes are very different from the original bench-scale process. I also received training working within GMP compliance, learning to understand the gravity of producing APIs that would be tested on human beings is critical in the pharmaceutical industry. Eventually, I joined Amyris, which was my first experience with fermentation products. This is very different from chemical synthesis, as bio-derived products have much more variability. No two fermentations are exactly the same in impurity profiles. This meant the team had to develop very robust processes while at the same time meeting the specifications deduced by the commercial team for customers. In the 8 years I worked with the Amyris team, we had very aggressive timelines and the team had to learn a fail-fast approach. For chemical conversion products, it was about the simplest path to the products, minimizing the number of steps and raw materials. We would try several routes and continuously narrow the possibilities based on testing until the process was defined, then we optimized. An opportunity at Antheia came at exactly the right time. I had built a team at Amyris that was doing really well, and the role at Antheia allowed me to apply my collective career experience from both the pharmaceutical ingredients side and the fermentation process development. It was the perfect combination, so of course I said yes. Q: What milestones in your career are you particularly proud of? One of my proudest accomplishments is that I played a pivotal role in helping the team at Amyris transition from chemical process development to fermentation process development. We were able to pivot quickly and successfully, taking 11 projects to commercial scale. Normally, it takes 18-24 months to develop and scale a process to manufacturing, so for the team to have scaled so many processes successfully in 8 years to meet specifications speaks volumes of their skill. More recently, I’ve been thrilled to be a part of Antheia’s efforts to scale our first products to commercial levels. In the four years I’ve been at Antheia, I’ve had the pleasure of building the DSP team and watching my colleagues grow into skilled industry-leading professionals and prove themselves with every successful run, from pilot to commercial scale. I’d like to think that my aspirations for being a teacher have still been fulfilled at Antheia. Q: Antheia’s core mission is to innovate and transform essential medicine supply chains. Tell us more about how your role as Head of Downstream Processing supports this mission. What are your key responsibilities? As soon as fermentation is complete, the DSP team takes control of the whole cell broth material to begin refining it; it’s our job to purify and isolate our products from what’s known as the fermentation broth. My responsibility is to ensure that we keep the big picture in mind, as it’s easy to become myopic and focus only on the immediate problems at hand, or even go down rabbit holes when conducting bench-scale work at 1-20L scale. Part of that is always remembering that our work must be able to apply to tech transfer, and it needs to scale up to a commercial scale of more than 100,000L. There’s a common misconception that scaling up processes is just about making the bench-scale work bigger, but it’s actually much more complex. Some of that complexity is that we have to be able to speak to the manufacturing team about the engineering aspects of our work, not just the chemistry. Since DSP goes through stages, we have to start with understanding the physical properties of the product. As we scale, we leverage this knowledge while keeping in mind the equipment we have to work with to implement our processes. Our Chief Operations Officer Zack McGahey recently touched on this aspect in his blog, The Road to Commercialization. Another key responsibility in my role is building and managing my team. Our DSP team is composed of both chemists and engineers, and this combination is crucial, in my experience, to ensure that our process can successfully be reproduced and scaled. What I’ve learned is that by the time you
Unleashing Joy: Introducing He-Man, Chief Dog Officer at Antheia
He-Man serves as Antheia’s Chief Dog Officer (CDO), where he has worked diligently to make a paw-sitive impact on employee morale, team dynamics, and the company treat budget. In this blog, He-Man shares more about his exciting life at Antheia and his invaluable role in boosting morale. From Humble Biotech Beginnings to Biomanufacturing Brilliance Before my journey at Antheia, I had my paws in the biotech world for quite some time. I worked at two biotech companies prior to joining Antheia, where I honed skills in boosting team spirit and spreading joy, especially in the area of trashcan digging operations. I was one of the earliest hires at Antheia, joining my human, Antheia’s Chief Scientific Officer Kristy Hawkins, and CEO Christina Smolke, who co-founded the company. In addition to being told that I’m a good boy and a great team player, it’s also been said that they couldn’t have done it all without me. I agree. One of my most important qualities as a teammate is my calm demeanor under pressure, which helps me focus on what truly matters, and encourages others to do the same. Whether we’re tackling complex scientific challenges or navigating intricate strategy decisions, I’m right alongside the team, reminding everyone that a little bit of positivity can go a long way. Picture this: Scientists engrossed in deep discussions about groundbreaking research and innovative biomanufacturing processes. You can imagine that it can be intense, so sometimes a little of my light-heartedness is necessary to keep the atmosphere balanced. I typically step in during meetings to unleash my charm and infectious energy, ensuring that everyone has a reason to smile. After all, a happy team makes for a happy workplace. Teamwork Makes the Dream Work I’m fortunate to have an excellent team by my side at Antheia. One of my closest collaborators is Suzy, the Head of DSP (they keep referring to it as Downstream Processing, but we all know it’s Doggy Snack Preparation). Suzy is responsible for crafting the most delectable lunches for my canine colleagues and I, a tradition that started originally with her lunch prep for her dog, Maddie. Here at Antheia, we have a culture of supporting the whole team, so over time, Suzy began making all of our lunches as well. She moonlights as the head of DSP, ensuring that our key starting materials (KSMs) and active pharmaceutical ingredients (APIs) are purified and isolated. Another important part of my role is serving as a mentor to the other dog employees. Ember, our Director of Dogs, joined us when she was just a pup with her human Ken, Antheia’s Head of Biology, and thanks to my guiding paw, she has climbed the ranks quickly. One of our more recent hires, Avo, is just getting her feet wet as an intern in Business Strategy, shadowing me and her human, Yen-Hsiang, who is helping her learn the ropes on the business side in his role as Head of Strategy, Partnerships, and Finance. A Day in the Life As a critical part of the Antheia team, I have the honor of uniting us through my cheerful presence and playful antics. Even when the scientists are grappling with the most intricate problems, a wagging tail can lighten the mood and a surprise “gas bomb,” as my mom calls them, can diffuse the tension and remind us all to find some levity in our day-to-day work. I take pride in setting these precedents for a dog-friendly office culture that embraces both productivity and playfulness. But as any good executive knows, it’s not all fun and games. As CDO, I adhere to a purposeful routine to remind my team that I mean business. I spend much of my day patrolling the office, enforcing our open door policy so that my team and I can take full advantage of the best napping spots and access all the treats we need. Of course, I also attend meetings where my presence is a vital part of our work, and as part of our commitment to sustainability, I do a trash can inspection at 5pm to make sure no one is wasting their lunch leftovers. “Have You Tried Trying?” When I’m not busy fulfilling my duties as the CDO, you can find me moonlighting as a coach for elite powerlifters at Boss Barbell Club alongside my championship human. I’ve picked up some valuable insights from the gym that I apply to my role here at Antheia. Just like in the gym, teamwork, dedication, and a positive attitude are crucial for success – and just like how the lifters at Boss Barbell Club are the elite, best-of-the-best, so is our team at Antheia. That means I expect only the best of them. “Have you tried trying?” is my mantra. It may sound harsh, but I only use it to help push everyone when they need a little nudge to achieve their full potential. Every pound matters in the gym, just as every ounce matters in fermentation. Being a Part of Something Bigger than Ourselves Serving as the Chief Dog Officer of Antheia is a role I wholeheartedly embrace, from spreading smiles to fostering a sense of unity among our dedicated team members. I am committed to making every day at Antheia a paw-sitive experience for our teams so that they can continue to make groundbreaking discoveries and advancements in Biosynthetic KSMs and APIs. While we’re focused on making products for humans at Antheia, I know that synthetic biology has the potential to change the world for all types of problems – who knows what the future could hold for us dogs! This meaningful work drives me to be the best Chief Dog Officer I can be, day in and day out and I’m proud to be a steward of Antheia’s culture. Follow Antheia on LinkedIn and Twitter/X, and for more content from the company’s Chief Dog Officer, follow He-Man on Instagram.
