What happens when the charging elephant of biotech—antibody-drug conjugates (ADCs)—meets the organizational complexity of a 300-strong analytical powerhouse? The answer isn’t just in the science; it’s in how you marshal people, tech, and trust to outpace the clock and deliver therapies that matter.

This episode features Amanda Hoertz, VP of Analytical Development & Testing at KBI Biopharma. Amanda’s spent her career navigating the thicket of biologics—from biosimilars to the most challenging ADCs—while shepherding one of the largest analytical teams in the industry. Her perspective isn’t just tactical: it’s rooted in tenacity, team stewardship, and a practical playbook for bringing next-generation modalities to market. Check the first part of our conversation.

Key Topics Discussed

• Inside KBI BioPharma’s approach to Antibody–Drug Conjugate (ADC) development and the importance of treating each molecule as a unique challenge.
• How dedicated program management and long-term client partnerships ensure consistency and clear communication across complex projects.
• Managing large analytical and process development teams through structured leadership, collaboration, and scalable resource allocation.
• Building organizational knowledge and stability through strong tenure, clear communication, and a culture of continuous improvement.
• The digital transformation of analytical operations—implementing LIMS, ELN, and automation tools to streamline workflows and enhance data integrity.
• Proven strategies for accelerating ADC development, including platform methods, proactive analytical problem-solving, and deep molecular understanding.
• Cultural foundations of success at KBI: loyalty, adaptability, and empowering teams to innovate and grow.
• Emerging trends in ADCs and biologics, leadership lessons for biotech professionals, and the evolving role of scientists in a rapidly changing industry.

Episode Highlights

• How leveraging institutional experience accelerates development for new molecules and biosimilars [00:00:00]
• The role of program managers and dedicated client teams in ensuring seamless collaboration at KBI BioPharma [00:02:46]
• Scaling analytical operations—managing a 300-person team with flexibility, loyalty, and clear decision-making [00:05:40]
• Knowledge transfer frameworks that preserve consistency and stability across large analytical organizations [00:06:01]
• Driving digital transformation through LIMS, ELN, and lab automation to enhance efficiency and data integrity [00:08:31]
• Platform-based strategies and analytical troubleshooting for robust ADC method development [00:12:11]
• Adapting to emerging trends in ADCs and biologics through investment in cytotoxic analytics and accelerated workflows [00:14:25]
• Leadership lessons in biotech—embracing change, delegating effectively, and seizing new opportunities [00:16:07]
• The promise of ADCs as targeted therapies offering improved efficacy and reduced side effects for patients [00:17:51]

In Their Words

We definitely look at each molecule individually, but with the experience behind us. So as I mentioned, our tenure before - that's a huge advantage. We remember the molecules that are similar. There are a number of biosimilars where it's not the first time they've come to KBI. So we kind of have an idea of where to go down that path, and that really helps us accelerate for later clients.

The same thing with ADCs: if we know what molecule or method is going to be the trouble method—so I've already said that's the charge heterogeneity—we know to start with that method first in our method development.

Episode Transcript: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up - Part 2

David Brühlmann [00:00:36]:
Welcome back to Part Two of our conversation with Amanda Hoertz from KBI Biopharma. I'm your host, David Brühlmann, and in part one we explored Amanda's journey and the fundamentals of ADC development.

Now we are diving into the nitty-gritty: the analytical puzzles, the formulation challenges, and the scaling strategies that make ADCs so complex. Amanda will share KBI’s innovative approaches, leadership insights from managing 300 scientists, and the future trends shaping biologics development.

Let's shift our conversation towards the more, I'd say, project management or organizational aspects. What are some key best practices you follow at KBI to accelerate the path of ADC development?

Amanda Hoertz [00:02:46]:
So the approach is the same whether it's ADC or non-ADC. What we've found at KBI works best is we have a program manager, and that stays the same for the client. But then we also have dedicated teams in each space.

Once you have a dedicated director and group leader—for example, in the analytical space—that will be the same person you work with for the life of the project. It helps because we learn what this customer wants versus that customer. Right?

This customer may want all the raw data exported and sent to them on a secure shared drive so they can make overlays. Another client may not need that. One client may want everything in a PowerPoint presentation, one may not. One may have a critical filing deadline, one may not.

So by having a consistent point of contact—and that contact will stay the same if you have another molecule at KBI—you don’t have to relearn that relationship. Everything is consistent. You know how to get what you need, and you also know when they need something for, let's say, an IND update. You understand who to talk to, and you know what they need. It's a good relationship. If the client invests in it and KBI invests in it, it makes everything a lot faster.

What we've seen at some CDMOs that we outsource services to—for example, sterility testing and CCIT (Container Closure Integrity Testing)—it’s very confusing as to who to talk to. So when we have investigations at those other partner sites, and we are responsible for the relationship, I sometimes struggle to get answers out of a director or somebody at a different company. Not going to name names because I don't want to badger anybody in particular, but it's confusing.

And I can only imagine as a client, when you have a critical filing for your IND and you need this file now—if you don’t know who to contact or can’t get a clear tree of responsibility—how frustrating that would be. So we try to make sure that it’s seamless.

I'm not pretending that KBI is perfect. There are definitely times when a client needs something and the timeline is insane. We try to meet it and do everything we can.

That’s one of the strengths of the analytical portion of KBI. So, a typical CDMO has a QC team of about 20 to 30 people that execute testing—usually release and some limited stability. KBI, at the Hamlin site alone, has 200 analysts, and in the network it’s 400—300 of which are under my supervision.

It means that if you need something as a client, I can throw basically a flood of people and a flood of instruments on something to make sure you get what you need. It's an army. We can absolutely destroy any task by rearranging priorities.

And that’s one of the benefits of having the mammalian network for analytical testing under me, and the process development mammalian network under Leslie Wolfe at KBI, is that we can adjust priorities in real time. There’s no in-depth conversation or negotiation.

And even with our microbial partners, we leverage each other’s teams to make sure that we get what the client needs. We have excellent relationships across our entire network.

David Brühlmann [00:05:40]:
Having that many people is impressive, and it can definitely be an advantage if you manage your network well—or your people well.

So my question, Amanda: how do you ensure consistency and knowledge transfer among this huge army? And what is your framework for building analytical methods that are robust and scalable?

Amanda Hoertz [00:06:01]:
I can’t take credit for this because I’m benefiting from my parentage at KBI—they’ve set this up in a very scalable way.

So, at the Hamlin site specifically, there are about 200 people. We have eight directors, and then below the directors are group leaders. Below the group leaders are project leaders. So it’s a very structured tree, and that structure drives knowledge transfer as well.

Basically, we’ve all been “raised” in this environment. The average tenure at the North Carolina Analytical and Formulation Sciences (AFS) group is almost six years. And the average tenure for managers is close to 10 years. That is atypical for the industry, and it’s really the key to our success.

We very much advocate for our people. That’s my job—making sure I’m doing everything I can for the analysts all the way up to the managers. And those managers do the same. That inspires a lot of loyalty and consistency.

If we’re not constantly turning over analysts, we can benefit from their knowledge base and also have the bandwidth to do improvement projects. Analysts are, of course, the most common turnover point, but even there the average tenure is almost four years—compared to the industry average of around two years. That’s a big difference, and we benefit from it.

I think once you have a good culture, it’s actually easier to maintain it. But when you allow that to degrade, that’s when you start to face bigger problems. So I can’t take credit for creating it—I’m just trying to maintain what was entrusted to me when I started leading the department. That’s how so many people can work together effectively.

We also all have the same mentality: we know we need to deliver for the customer. There’s no confusion about priorities, and we have a very clear decision tree.

If I talk to one of my directors who’s working on a project and I say, “This other project has reached a critical status and we need to rearrange priorities,” first of all, we have the depth to move things around. Second, everyone understands how that priority was determined—and then it’s done.

And it works the same way for me. If my boss, Sigma Mostafa, our Chief Scientific Officer, tells me, “I need you to make sure this client or this activity is completed,” we just do it. Not in a military way, but in the sense that it’s clear: the decision has been made, now it’s time to execute. That clarity really helps.

David Brühlmann [00:08:08]:
That’s fantastic. I think clarity is key, and it’s great that you can leverage this huge network. So I’m curious, Amanda—you mentioned the culture is great and you put a lot of work into it. But on the technical side, how has digital transformation changed the way you operate? And how are you leveraging new technologies?

Amanda Hoertz [00:08:31]:
That’s a great question. Starting with things like a LIMS (Laboratory Information Management System) and an ELN (Electronic Laboratory Notebook), we’ve been rolling those out.

Hamlin is our largest site, so it’s always going to be the slowest to adopt new technologies. Right now, we have LIMS operating at our non-GMP sites and at two smaller GMP sites—our Boulder site (microbial) and our Geneva site (mammalian).

We are implementing LIMS across the network. As you’d imagine, we have over 650 active stability studies. Bringing those in from a paper-based system to electronic will take time, so we’re triaging and doing it incrementally. Our target is to be fully transitioned by the end of 2025.

That shift allows us to instantly understand statuses, compile data for clients, and track things in a much more robust way. We’ve had a very successful paper system, but paper can be damaged or lost. Electronic systems, when backed up properly, cannot. Same story for the ELN system—it’s already in place at our GMP and non-GMP site in Boulder, and at our non-GMP mammalian sites, and now we’re bringing it into our GMP mammalian sites.

It will allow us to link everything faster. Right now we already provide all raw data to clients, but it’s literally scanned pieces of paper. Soon, we’ll be able to deliver it in fully electronic format, searchable and linked—much more efficient.

Finally, at our non-GMP site we’ve implemented a lot of automation. Tecan systems are huge. For example, Derek Ryan, our Senior Director of Analytical Development in the mammalian network, and his team rely on them to process the hundreds and thousands of samples needed for PD on a regular basis.

We tried implementing a Tecan at our GMP site, but the complication was that the audit trail is essentially code—not straightforward for compliance. So Derek’s team tested alternatives in the non-GMP space. They pulled in the Waters Andrew+ pipetting systems. While they’re not using them with GMP audit functionality in development, they do have validated GMP audit trails.

So we purchased those for our GMP sites. The Waters Andrew+ systems take away all the repetitive pipetting from analysts. That improves consistency, reduces deviations and investigations, and allows analysts to set up ELISAs, dilution series, everything, and then just pop plates into the reader. Crucially, it has a clear GMP audit trail that reviewers can audit and understand. That’s a huge advancement.

On top of that, at KBI we have a very large amount of formulation development data. We’ve started to put that into a database and are using machine learning to see how we can predict formulations. For example, if a client needs a quick formulation—not fully optimized because of limited time or budget—we want to be able to set them up with the best possible chance of success.

All of these are works in progress, but it’s an exciting time. We’re adding efficiency and reducing some of the manual workload our analysts face.

David Brühlmann [00:11:57]:
Speaking of success, Amanda, what would you say are some best practices you follow to accelerate the path of ADC development? And what is core to your company culture that enables that?

Amanda Hoertz [00:12:11]:
We definitely look at each molecule individually, but with the experience behind us. As I mentioned, our tenure is a huge advantage. We remember the molecules that are similar. There are a number of biosimilars where it’s not the first time they’ve come to KBI, so we know where to start, and that helps us accelerate for later clients.

Same thing with ADCs—if we know what molecule or method is going to be the trouble spot (for example, charge heterogeneity), we start there in method development.

We also have a team, where after method development, they immediately start with method qualification. We have a number of platform approaches where we begin, and then we follow the molecule because it can always be different. But we understand where to start and what levers to pull—whether that’s improving resolution, improving a separation, or refining the method.

We make sure the method fully develops—whether that means resolving charged species, separating HMWs (high molecular weight species), or ensuring the peptide map is truly resolved.

We once had a client come to us with a charge method that showed only a single peak. They loved it, but we had to explain: if you’re not separating anything, the method has no value. We then showed them what could actually be separated with that method. They didn’t love seeing more than one peak, but for a method to be meaningful, it has to actually resolve species.

David Brühlmann [00:13:33]:
That’s a great example.

Amanda Hoertz [00:13:37]:
They didn’t like that very much, but we got them to where they needed to be.

David Brühlmann [00:13:40]:
I know, I know. It reminds me of some conversations I had in my career. I’d say technological advancements are not always welcomed, let’s put it like that. I’m not going to name names.

Amanda Hoertz [00:13:51]:
No, exactly. We want to understand—because that’s how the differences between batch one and batch two may be explained. If you see a difference in performance, you want to understand why. And as the industry continues to evolve, we may see different things. We may achieve better separation, we may now understand what the differences are. And we have to accept that.

David Brühlmann [00:14:13]:
Yeah, definitely. And there’s a lot going on, the industry is evolving. So what is your vision for the future of ADCs and biologics development in general? What trends do you see?

Amanda Hoertz [00:14:25]:
It’s really exciting—and I love it for patients. Having more targeted therapies and more options is huge.

We saw this in the early days with biologics—early IgG1s and IgG2s required much more customization to understand what you were doing. Now, many of those approaches are platforms. As we continue to see more ADCs produced, we’re going to get more comfortable with how to manufacture them efficiently, cost-effectively, and how to identify winners and losers faster. That’s huge.

KBI right now has the ability to test non-cytotoxic ADCs at all of our sites, and cytotoxic ADCs analytically at two of our sites. What we’re investing in is another U.S.-based lab where we can test GMP cytotoxic ADCs safely within the mammalian network—covering both process development and analytical development.

That’s going to require significant capital investment, since handling large amounts of toxic payload requires specialized facilities. We’re still determining whether to partner with clients for GMP production through a vendor or to build those capabilities fully in-house. But we see this as the next frontier, and we’re making those investments to grow with the industry.

Given our experience with niche molecules and with ADCs, I think we’re in the right position to maximize the benefit for patients.

David Brühlmann [00:15:47]:
So, you’ve built a successful career leading a team of 300 people. What advice would you give biotech scientists looking to excel in complex modalities like ADCs—and also in managing large, cross-functional organizations that aren’t all at the same site?

Amanda Hoertz [00:16:07]:
For managing a site this large, it all comes down to having the right people working for you and with you. There’s no way I could directly handle all the issues that can come up with 300 people. My direct reports need to be empowered to handle things, and then we triage as issues move up and down. That’s critical.

For building a successful career: people don’t love change, but change is part of what we do. My job has changed over the years, the industry has changed over the years. Absorbing information and being willing to move with what’s hot and what’s emerging in the market is important.

ADCs can be intimidating. There are plenty of drugs that don’t have toxic payloads, that are easier and lower risk. But this is where the industry is going. We need to find ways to develop them safely and successfully—for both patients and employees. So being nimble and willing to move with the market is critical.

When I came to KBI, I only intended to stay for two years. But I was in the right place at the right time, opportunities came up, and I took them. I don’t think there was a master plan. And I think many of my colleagues at KBI have had similar experiences—as the company grew, opportunities appeared, and it’s been a great place to be. I don’t know if that kind of growth can be planned or replicated—it just comes down to being willing to do what’s needed to make the company successful.

David Brühlmann [00:17:41]:
Well, this has been great, Amanda. Thank you so much for sharing your passion and insights. What would you say is the most important takeaway from our conversation?

Amanda Hoertz [00:17:51]:
I think the most important takeaway is that ADCs are an exciting new therapy, and they represent a significant improvement on existing therapies—providing patients better outcomes with fewer side effects.

There’s such a rich pipeline in the industry right now, and being able to adapt and characterize these biologics is the next challenge. We’re looking forward to being part of that solution for the industry. Thanks so much for taking the time to talk with me today—I really appreciate it.

David Brühlmann [00:18:12]:
That’s fantastic. Amanda, where can people get a hold of you?

Amanda Hoertz [00:18:16]:
The KBI website is a good place. There’s also our dedicated portal, https://standalone.kbi.bio/, which allows you to get quick quotes, ask questions—it’s very interactive and easy to use. We jokingly call it the “Domino’s Pizza Tracker” for biotech, because you can submit a request and then see exactly where it is in the process.

David Brühlmann [00:18:33]:
Excellent. I’ll leave all the links in the show notes so listeners can find them easily. And once again, Amanda, thank you so much for being on the show today. It was a huge pleasure.

Amanda Hoertz [00:18:43]:
Thanks, David. I appreciate it. Bye.

David Brühlmann [00:18:46]:
What a fascinating conversation with Amanda Hoertz. Her insights on ADC development, analytical strategies, and leadership are invaluable for any biotech scientist.

Please leave us a review on Apple Podcasts or whatever platform you found us on. It helps other biotech scientists like you discover the show. I thank you so much already - and I love hearing from you. So thank you very much for tuning in today. Stay tuned for part two where we'll dive into the analytical complexities of ADCs.

For additional bioprocessing tips, visit us at Smart Biotech Scientist Podcast - Master Bioprocess Development. Stay tuned for more inspiring biotech insights in our next episode. Until then, let’s continue to smarten up biotech.

Disclaimer: This transcript was generated with the assistance of artificial intelligence. While efforts have been made to ensure accuracy, it may contain errors, omissions, or misinterpretations. The text has been lightly edited and optimized for readability and flow. Please do not rely on it as a verbatim record.

Next Step

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

🧬 De-risk CMC development and get decision-making guidance with a new AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com

About Amanda Hoertz 

Amanda Hoertz is the Vice President of Analytical and Formulation Sciences (Mammalian Network) at KBI Biopharma, where she leads a team of more than 300 analytical scientists. Her organization supports method development, verification, qualification, validation, formulation design, forced degradation studies, characterization, and stability testing across preclinical to commercial-stage biopharmaceutical products.

With over 14 years at KBI, Amanda brings deep expertise in analytical strategy and biopharmaceutical development. She earned her Ph.D. in Chemistry from Duke University and holds additional academic experience from Johns Hopkins University and the University of Pennsylvania.

Connect with Amanda Hoertz on LinkedIn.

He is also a biotech technology innovation coach, technology transfer leader, and host of the Smart Biotech Scientist podcast—the go-to podcast for biotech scientists who want to master biopharma CMC development and biomanufacturing.  

Hear It From The Horse’s Mouth

Want to listen to the full interview? Go to Smart Biotech Scientist Podcast. 

Want to hear more? Do visit the podcast page and check out other episodes. 
Do you wish to simplify your biologics drug development project? Contact Us