BIO 2026: Bridging the Complexity Gap
Complex, targeted medicines are introducing bottlenecks into the CMC pathway, creating critical hurdles for clinical scale-up, emphasizes Henny Zijlstra from Ardena.
Scaling a drug candidate from benchtop discovery to standard multi-kilogram GMP batches represents an exponential escalation in complexity. For advanced nanomedicines and specialized drug conjugates, this transition is particularly treacherous. Traditional small-molecule approaches fail to accommodate the intricate multi-component assemblies required to keep these modern formulations stable and efficacious
“Scaling targeted nanomedicines and drug conjugates is still hard... and it usually comes down to the execution,” says Henny Zijlstra, CCO at Ardena. “So, first, the conjugation — getting the drug and targeted part to attach consistently is not straightforward. If you don't control that well, you quickly run into variability and impurities.”
Beyond the structural conjugation chemistry, characterization remains a definitive operational threshold. Standard analytical paradigms cannot fully evaluate or qualify these hybrid entities. Zijlstra emphasizes that analytical deficiency creates structural risk across downstream processing.
“These systems are complex and standard methods often can't fully characterize them,” Zijlstra notes. “That makes it harder to really understand and control quality. You also have stability challenges. Many of these molecules are fragile, so you need the right conditions and expertise to keep them functional.”
Moreover, the structural environment required to handle these formulations elevates cost metrics. Because the operational chemistry heavily relies on aqueous processing, facilities face intensive cleanroom dependencies. “Most processes run in aqueous systems, so you're dependent on cleanroom manufacturing and strict contamination control. That adds cost and complexity,” Zijlstra states. “And finally, scale, what works in a lab doesn't easily translate to production, and keeping batch-to-batch consistency remains a major hurdle.”
As candidate complexity spikes, bioanalysis can no longer function as a late-stage check-box exercise prior to investigative new drug (IND) filings. In modern precision engineering, analytical validation must run parallel to early formulation chemistry to avoid catastrophic, late-stage structural or clinical failures.
“Bioanalysis is becoming more important, not less.,” Zijlstra asserts. “Therapeutics are getting more complex. Molecules are becoming more tailored and multi-modal. The way we measure them needs to keep up. You often can't rely on a single method anymore. You need multiple approaches, sometimes across different platforms to really understand what is happening.”
According to Zijlstra, executing a functional clinical strategy hinges entirely on early bioanalytical integration. A developer may synthesize a highly potent compound, but if that compound cannot be precisely measured at low limits of quantitation within biological matrices, clinical translation halts.
“Timing is critical. The earlier you think about bioanalytics, the better. If you don't plan early how you are going to measure your molecule, you can run into major problems later,” Zijlstra warns. “Regulatory expectations are also increasing. Agencies are looking more closely at bioanalytical strategies, especially for the complex therapeutics.”
Market demand continues to pivot sharply toward high-potency and targeted indications. Oncology remains the dominant clinical anchor, marked by highly potent substances with limited solubility profiles that demand advanced bioavailability enhancement. Simultaneously, accelerated clinical timelines and rare disease indications are forcing smaller, ultra-precise batch operations where developer agility, biomarker strategy, and robust CMC packages are critical for clinical validation and securing secondary funding.
A profound shift in biopharma macroeconomics is the proliferation of virtual biotechs—highly capitalized, asset-light entities driving breakthrough science without retaining a physical manufacturing footprint. This creates a critical demand for structural and operational incubation that traditional, transactional CDMO vendor models are poorly structured to fulfill.
“You simply cannot get away from being just a service partner in the industry,” Zijlstra remarks. “You have to be a true development partner. A lot of innovation today comes from the virtual biotech because they have the science, but they don't have the infrastructure. So they don't need just the execution. They need our guidance.”
To successfully transition these asset-light innovations through clinical benchmarks, CDMOs must take early, holistic ownership of the development lifecycle, bridging the gap between raw research and commercial manufacturability. Zijlstra highlights that this requires moving away from modular silos toward completely integrated teams across formulation, bioanalysis, and fill/finish.
“Early-stage biotechs... need flexibility and speed and clear decisions. The model from us switched from 'you tell us what to do' to 'we help you define the right path and we execute it with you',” Zijlstra comments. “Because in the end, any virtual biotech, you don't need a vendor, you need a partner that can work with you, that can reduce the risk, and that can grow your molecule successfully with you.”
As precision therapeutics become increasingly elaborate, Zijlstra notes that clinical success relies entirely on expert scientific judgment. “Clients are not simply looking for capacity, they're looking for scientific judgment,” she summarizes.
Bionova Scientific will be exhibiting at this year’s BIO conference at stand #3253
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About the Speaker
Henny Zijlstra is Chief Commercial Officer at Ardena. Henny joined Ardena as Chief Commercial Officer in May 2026. She is an accomplished commercial leader in the pharmaceutical and CDMO industry, with a career built on driving growth through strategic business development, brand positioning, and customer engagement.
Henny has held senior commercial roles across the sector, including at Lonza and most recently at Adragos. At Ardena, she leads the commercial organization across business development and marketing, with a focus on strengthening Ardena’s market presence and supporting customers in complex molecules, nanotechnology, drug conjugates, and bioanalysis.
Henny believes that strong commercial performance is built on trust, authenticity, and meaningful relationships. She leads with a clear focus on results and on helping customers connect with the specialist expertise they need to advance complex therapies.
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