Behind the scenes of building a biotech: Tearing my hair out over cold shipping logistics & kicking off Round #2 of external testing for FBS Replacement Solution (FRS). Highs/Lows of the month ⤵️
The highs 🎉 1️⃣ Round #2 of external testing has started! It felt like I visited every major scientific research institute in Melbourne so a huge shoutout to our collaborators and everyone who offered an introduction. Startups and children both take a village! Cell culture media is cool because it underpins so many research areas - from improving our fundamental understanding of biology to creation of new therapeutics - and round #2 covers all of that ground. 2️⃣ Import licenses were approved & supply chain is on track. 3️⃣ New cells & minor technical breakthroughs! Our FRS product information sheet will soon include the growth curves for a wide variety of common immortalised cells - in addition to the nutritionally demanding primary cells we’ve already tested. 4️⃣ While we are sticking to our “lean, mostly bootstrapped biotech” philosophy, the 2024 efforts we put towards grants are paying off. Will share our learnings after the final signatures are sorted 😊 The lows 🙃 1️⃣ Cold shipping logistics are tough, especially if you’re located in a regional area of Australia. We had a few FRS deliveries for pilot testing which weren’t as smooth as we’d have liked. You might think “external testing” is mostly for product validation…and it is, in part. But it’s also the time to iron out shipping processes, instruction manuals, and other user-facing interfaces. 2️⃣ Getting paid by overseas folks can be unexpectedly complicated…also important to sort this out now versus later. 3️⃣ I got sick. It slowed us down. The ugly reality of a small company. Overall feeling? Momentum is so energising. Still, I’ve found founder life is a lot like managing a big team; you could be doing an objectively excellent job but there is still inevitably something which is a little bit on fire. Managing that emotional roller coaster is key and I’m grateful for the support system around me (though advice in this area is always welcome!)
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Behind the scenes of building a biotech company: Previously, I worked with a North American startup company who decided to send their CSO on a massive, multi-month trip around Asia to get physically into the laboratories of their earliest collaborators. To me, this seemed excessive. I was dead wrong.
On that note, I’m heading to Melbourne! Not indefinitely, just for a few days (sorry Melbourne friends) Currently, we are getting samples of our chemically defined and animal-free replacement for FBS into the hands of scientists across Australia who want to reduce or eliminate FBS in their cell culture. 🧪 We’ve learned a truly astronomical amount from this pilot phase. As expected, we’ve been able to gather some nice growth curves of cells growing without FBS which we wouldn’t have been able to test on our own. 🔬 But it’s the laboratories in which things haven’t immediately gone according to plan where the really interesting learnings from a company-building perspective have emerged. To make a truly user-friendly product, in the earliest pilot testing stages it’s not enough to just send the product instructions and the product. This stage works best when both you and your amazing collaborator (who’s taking a chance on you!) are fully in the project together - think looking over the experimental plans and exchanging photos in real time. Or ideally, being physically in the lab together. Now, it makes a lot of sense why that North American CSO was spending two weeks with every company that was trialing his technology. And while my own world tour is not on the cards yet, the rest of Australia is certainly within reach. So on that note, I am heading to Melbourne with a big batch of FBS Replacement Solution (FRS) soon. If you’re a scientist interested in removing FBS from your cell culture, I’d love to hear from you, make arrangements to meet in person and see whether we can collaborate to make cell culture more reproducible, cleaner, and animal-free. Of course, the same applies to Sydney-based scientists but you don’t need to wait until I make a special trip! 📷 Excitement at having completed manufacturing batch #1! Before 2024 wrapped up, we manufactured our first batch of FBS Replacement Solution (FRS) for external use. We hand-delivered to scientists at CSIRO and shipped to as a small cell therapies company based in Melbourne.
Along the way to hitting this milestone, we learned an awful lot:
As we roll into 2025, we have plans to ship and deliver FRS to laboratories and small companies across Australia. During the next 6 months, FRS will be tested on a broad range of cell types. We are especially prioritising companies or laboratory groups trying to reduce or eliminate their dependence on FBS for regulatory reasons, so please reach out if that’s you and we will set up a call. From there, we will scale our manufacturing capability. To date, we have compelling data that shows FRS supports the long-term growth of primary cells including muscle stem cells, fibroblasts and chondrocytes, as well as immortalised cell lines such as CHO. We are happy to share a product sheet with data and growth curves upon request. Here’s some interesting science you probably didn’t know (plus the Media City Scientific origin story):
15 years ago, the first journal club I ever delivered looked at the effects of culturing cells in serum derived from different animals. 🐁 Mouse cells cultured in human serum had a human-centric immune response. 👩🔬 Human cells cultured in mouse serum had a mouse-centric immune response. …And isn’t it interesting to consider these results in light of the fact that (all types of) cells are most commonly cultured in serum from fetal cows? 🐮 These findings lived rent-free in my mind until 2024 when I decided to do something about it. Like many scientists, I’ve cultured a lot of cells in FBS because “it works” and “that’s how everyone does it.” Like many scientists, I could also list the reasons why FBS is far from ideal scientifically and ethically. So, I started by optimising a chemically defined supplement for the most nutritionally demanding primary cells I had worked with, then expanded to other primary cell types and immortalised cells. One year later, we’ve started shipping an alternative to FBS that supports the growth of a broad range of cells. I’m a scientist, so I’m naturally skeptical, but I’ve collected enough data to feel pretty stoked about the direction of 2025. It’s also been about a year of being public on the internet about the company journey - mostly musings on cool science and startups, sharing learnings from founding a boot-strapped biotech as well as my previous four years with a hypergrowth, VC-backed startup. I’ve met so many scientists and engineers from around the world, and you've made this whole journey extra rewarding. Who knows? Maybe you’ll also find your life circling back to the very first journal club you ever delivered. ______ Much more science can be found in the paper by Warren et al: Resilience to bacterial infection: difference between species could be due to proteins in serum. It’s open access! 🥳 Graph shows how mouse cells differ in TNF production following challenge by 20ng/mL of LPS, when cultured in different types of serum. It also shows an inverse relationship between the lethal sensitivity of each species to LPS and TNF production by mouse cells cultured in each species' serum. The good news for this particular research model? Calf serum aligns with human serum more closely than many other species. Is this always the case? Time will tell.... I came across this article from a few years ago and thought it was rather interesting and concerning1/9/2025 The article outlines how a group illegally smuggled 13,000 L of FBS from South America into Australia, posing a significant biosecurity risk. The smuggled FBS was used by the CSIRO in its cattle research and had the potential to introduce foot and mouth disease into Australian herds.
Events such as these underscore the value in replacing FBS with a broad spectrum chemically defined replacement. Bovine blood products illegally smuggled into Australia in international conspiracy - ABC News Behind the scenes of building a biotech company: A big milestone unlocked and supply chain dramas 🥳 😵💫
The highs: 🥳 1️⃣ I’m so pleased with how our FBS-replacement solution, FRS, is looking. I’ve been working out the final shipping format over the past months, and every time I go into the laboratory and see a wide range of cells growing in FRS after weeks and months, it just makes my heart happy. 2️⃣ Product is being shipped to scientists doing important work, who want and need to replace FBS in their cell culture. Some of these folks have worked alongside me in the past, and it feels really special to share this moment with them. Frankly, I probably need to pause and celebrate this milestone a bit more. I think it just doesn’t feel real yet. The lows: 😵💫 1️⃣ Gosh, life sciences supply chain can be so tough in Australia. Reagents might come with a quoted 6-8 week lead time...but sometimes I’ve seen that become 4+ months if it arrives at all! Sometimes I wonder if I should just fly to the US to visit family & pick up reagents at the same time! (Would this make the flight a business expense? Not sure what the import implications would be, so please don’t interpret this musing as a recommendation!) 2️⃣ The last 2 months have brought some personal life challenges. One of my jobs as company leader is to constantly assess “what are the biggest risks to the business right now?” Reality is, at this tiny stage of company growth, if something slows me down even marginally, it’s going to slow down company progress as well. Something I’m keen to de-risk as we move into 2025 and figure out what scale-up looks like. Overall, it feels good. I’m a cautious scientist by nature, but I’m becoming increasingly excited about the potential FRS has to replace a great deal of FBS out there - making cell culture more sustainable, consistent, and contaminant free. Photo: Our first labels! It’s getting real 😍 This week in "behind the scenes of building a biotech company", it's IP protection, manufacturing and marketing! And - of course - a lot of cell culture. Scientists, don’t believe anyone who tells you starting a company is glamorous 🙃
Here’s the fun part of building a company ➡ You'll work across all areas of the business as you build the version 1 of all major processes. Here’s the reality of starting a company ➡ Initially, those self-developed V1 processes won’t be all that great. Where we’ve needed to upskill over the last month: 1️⃣ Forming a well-researched opinion on intellectual property strategy 2️⃣ Website design, company branding, and sales 3️⃣ Manufacturing, supply chain, and distribution strategy for scale and geographies 4️⃣ Financials big and small: from stress-testing our funding strategy to improving our accounting Where I’m confident: ✅ The science behind the product: As we would hope, given how long I’ve been a scientist! ✅ The market: Arguably the most important area to nail as an entrepreneur. ✅ Hiring, growing, and leading a technical team: It’s critical to make the right hires at the right time. I’ve done enough of this previously to be confident we’ll do a great job. ✅ Our ability to figure it out: Look, I’m naturally a little bit skeptical and a realist, probably “too much of a scientist” and not quite the ambitious, overly confident entrepreneur that plenty would argue I need to be in order to launch a company of this magnitude. But we’ve built a laboratory, made the necessary technical progress, spoken with hundreds of potential customers, built V1 pipelines in all the critical areas, and have done so on a shoestring budget. This time last year, all of those goals felt insane. Turns out that Katie-one-year-ago was capable of more than she thought she was. So manufacturing and scale-up strategy, let’s bring it on. When I decided to build a biotech company, there were a series of routines or small habits I committed to. The goal? To build momentum across the many parameters of running business - from technical to customer to finance.
A few months in, here’s how those routines are compounding: ⤵ 1️⃣ Our laboratory is just down the road from my house. The convenient location means I run experiments constantly - including weekends & public holidays. ➡️ It’s not glamorous, but it’s honest work. I’m obsessed with this problem and have made good progress - but that’s a topic for a more technical post, coming soon! _______ 2️⃣ I share something I’ve learned publicly at least once a week. ➡️I grew very quicky in my previous role at an early-stage startup but didn't have the time/mental space to solidify those learnings. Humans learn best by teaching and I'm clearer on how to hire/lead/grow a team of scientists following this period of reflection & writing. Other positives: ✅ Helped a friend hire a scientist for her early-stage startup ✅ Found my first customers & collaborators ✅ Sending my words into the world felt intimidating, but so did the idea of shipping a product. Had to start somewhere! Hopefully it’s also useful for other scientists interested in entrepreneurship - that has always been the primary goal. _______ 3️⃣ I receive a daily update of the newest hits on google for my areas of scientific interest. ➡️Lots of new scientific learnings 😊 _______ 4️⃣ We're regularly applying for grants that Media City Scientific qualifies for. ➡️Some failures, but enough success to keep us funded! My co-founder takes on the lion’s share now; most government grants are administrated by non-scientists, so tailoring applications to the appropriate audience is important! I built my own cell culture facility in order to complete the early-stage R&D necessary to start a biotech company. Here are the questions that land my inbox most weeks ⤵
Wait, you built your own lab? That’s crazy! How did you do that? ➡️ I previously built a lab while working at another early-stage startup. My husband had just finished building our house, so we figured a laboratory couldn’t be too much more challenging. ___ How much did it cost? ➡️ We spent ~14k USD (20k AUD) to establish the laboratory. It required some investment, but it was much less expensive than most people expect! Factors that helped us do a lot with a limited budget: 💵Performing some of the building work ourselves (e.g. dry wall) 💵Purchasing second-hand lab equipment 💵Claiming 43.5% of R&D spending back from the Australian government (very helpful!) ___ Why didn’t you just rent lab space? ➡ I live ~2 hours from Sydney. Because this is regional Australia, there are no rental lab facilities nearby. I wanted the lab nearby so R&D could happen seven days a week. ____ Weren’t regulations a pain? ➡ Regulations were less complicated than I expected, largely because I'm not working with genetically modified organisms or anything similar. I am sure these vary between countries. ____ What are you doing in your lab? ➡ I’m developing a chemically defined, animal-component free substitute for fetal bovine serum. I’ve achieved some exciting results with a variety of nutritionally demanding primary cell types and will be sharing more soon 🎉 ____ That’s so cool that you built a lab! ➡ Thanks! I'm super excited about it! ____ Happy to answer any other questions - or give advice if you're thinking about doing this too! ____ 👋 I’m building a biotech company and sharing some of the behind-the-scenes online, in the hopes of lowering the barriers to entry for other scientists interested in commercialization. I’ve spent over 15 years working in mammalian cell culture labs, so a few years ago, I was happy to transition away from the bench to a more management-oriented role.
Being a people manager is a huge responsibility; you inevitably have a massive impact on the lives and careers of your direct reports - for good or for bad. I also gained a lot of satisfaction from assembling the ideal team; one whose individuals’ strengths and weaknesses complimented each other, so they could achieve goals at maximum efficiency. And so, I wondered whether “returning to the bench” as I start my own company might feel monotonous compared to the new challenges around team management I had been enjoying. I shouldn’t have worried. Today, I get a bit of a thrill whenever I enter my lab; I built this lab and I own the IP I’m generating here! It still feels like this crazy dream I’m living and as a result, something as simple as passaging cells feels really cool. __________ Outside of the lab, here’s what I’m learning from building: 1️⃣ Get your webpage up. Someone told me “Get a landing page up early, even if it’s not the most gorgeous landing page, because you’ll learn a lot based on how people interact with it.” So true - and it has been really motivating to get emails from folks from around the world, keen to eliminate their use of FBS. 2️⃣ Build relationships early. I’ve been in the early-stage startup world for a while; it’s a world where research pivots really fast. Those pivots don’t happen so quickly in academic and other industry labs, so it’s been encouraging to realise that I can and should start conversations with collaborators early. 3️⃣ Old habits die hard. Awareness of the traps you’re predisposed to fall into and a team that holds you accountable is critical. Here are some areas I improved in after holding an executive role at a startup company: ➡️ Spending money as needed to reach research goals ➡️ Owning how capable I am ➡️ Saying no Here are the traps I’m continually reminding myself to avoid now that I’m building my own company: ➡️ Being too frugal ➡️ Hesitating to vocalize big goals to others because I feel insecure ➡️ Spreading myself too thin An embarrassing amount of overlap 🙃 Thankfully, being aware of the traps I’m predisposed to fall into means my community knows what to hold me accountable on. With their help, it won’t be those traps that get me! |
What's been happening?Sharing the Media City journey is important to us because we want to encourage the next generation of scientists to establish companies that will advance scientific research. Check back regularly for the "building in public" updates on what it looks like to establish a scientific company. Archives
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