A Rapid Evolution: Highlights and Insights from Advancing Complex Biologics Day 2025
The biologics sector is rapidly evolving thanks to scientific innovation and investment. In this article, insights and perspectives from a selection of senior leaders shaping the future of biologics are reviewed.
Rising demand for personalized medicine and increasing disease burden around the world are contributing to growth in biologic-based therapies, which have the ability to meet unmet clinical need in a variety of therapeutic areas. Current estimates have forecast the biologics market to grow at a compound annual rate of 9.1% over the next decade, with next-generation biologics further driving market growth (1).
To discover more about the science, platforms, and strategies that are accelerating progress in biologics, Fierce Biotech, in partnership with Orientation Marketing, convened a selection of top executives and innovators from pharma and biotech companies for an exclusive one-day event (2). Here, the perspectives shared by these senior leaders shaping the future of biologics are reviewed, and the advances in manufacturing, evolving CDMO models, and upcoming opportunities in next-generation modalities are highlighted.
Scaling Up Through Automation and Efficiency
“Therapeutic proteins have come a long way from just being mAbs [monoclonal antibodies],” noted Deniz Kent, Co-Founder and CEO, Prolific Machines, during one of the tech talk sessions from the Advancing Complex Biologics Day (2). “The world is becoming a lot more complex, and with that increased complexity comes increased manufacturing challenges.”
These challenges mainly fall into one of four categories, Kent continued. “One is proteins have a short half-life. The second is proteins that are toxic to the host. The third is proteins that have complex PTMs [post-translational modifications] and take a long time to fold. And, the fourth is proteins that are signaling molecules that signal back to the host and disrupt their growth,” he said.
“In all of these cases, these are temporal control problems, meaning that if you could precisely control the timing of when you want to make certain perturbations, then these problems can be solved,” Kent specified. “This is important because Prolific has been building a system with extremely high temporal control at extremely low cost.”
The way the company has managed to achieve this is through a next-generation biomanufacturing platform that uses light to precisely and reversibly control protein production inside cells, addressing persistent challenges in therapeutic protein manufacturing. “We can toggle on and off [the] protein of interest by shining light on the cells, by taking advantage of the shape change that naturally happens when you expose these proteins to light,” explained Kent. By combining engineered light-sensitive proteins, modular illumination systems, and closed-loop machine learning, Prolific aims to enable fully autonomous bioreactors that lower production costs and improve scalability.
Focusing on RNA interference (RNAi) — small interference RNA (siRNA) in particular — Stefan Lutz, PhD, SVP Research, Codexis, pointed out that the growth in demand for this therapeutic modality is leading to a need for new manufacturing solutions. To meet this demand, Codexis has developed its next third-generation technology, the ECO Synthesis Platform — a fully enzymatic, aqueous-based RNAi manufacturing technology that replaces harsh chemical synthesis with scalable, sustainable, and high-quality production.
“This third-generation approach is turning nature’s enzymes for nucleic acid synthesis into industrial bio catalysts and making them an integral part of the oligonucleotide process,” Lutz confirmed. Additionally, he revealed that Codexis has developed a molecular toolbox of engineered enzymes and processes that can deliver on both second and third-generation oligo manufacturing processes.
“Our two-step process today operates on par with chemical synthesis,” Lutz explained. “An important distinction of this process is that not only does it run entirely under aqueous conditions, but it uses the enzyme as a true catalyst, allowing us to immobilize the enzyme while keeping the oligonucleotide in solution. This offers a critical advantage in regard to process scalability and allows for batch sizes that are significantly larger than what today's chemical processes can accommodate.”
With siRNA demand expected to double by 2030, Codexis’s Eco Innovation Lab, which was opened earlier in 2025, now supports annual production of oligos of up to 100 g, with enhanced synthesis of modified oligonucleotides.
An Evolving CDMO Model
For service providers, being able to scale production successfully and accelerate development timelines is key for complex modalities such as bispecific and trispecific antibodies. “Having flexibility and contracts so you can navigate [is important] as science goes sideways all the time,” specified Jesse McCool, Chief Scientific Officer of Bionova, in a fireside chat session from the Advancing Complex Biologics Day (2). “Really, having a sort of program management group that just helps move the teams forward and we can leave all the business discussions for later on, that’s really one of the most important things.”
This agility first mindset is embedded in the company’s ethos as its compact scale enables agile operations and integration of client-specific equipment, while the backing of parent company Asahi Kasei ensures stability and ongoing investment in advanced infrastructure. “[We] always tell people it's like coming to a smaller scale nimble company, not a start up in the sense, because we're backed by a large parent, multi-billion dollar conglomerate,” added Darren Head, Chairman and President at Bionova. “There's plenty of capital to support us as we grow, but you also get the flexibility and being nimble with an excellent science team.”
Having a disruptive impact on traditional biomanufacturing is Indian CDMO Enzene, with the latest version of its fully connected continuous manufacturing (FCCM) platform, EnzeneX 2.0. Through integrating upstream perfusion, real-time monitoring, and streamlined downstream purification, the platform significantly improves yield, consistency, and cost-efficiency, specified Mansi Bodani, General Manager, Analytical Development, Enzene.
“Using this technology, we are able to reach mAb production costs of less than $40 per gram,” said Bodani, highlighting Enzene’s ambitions to position itself as a global CDMO supporting both biosimilars and novel biologics.
Innovations and Hurdles in Advanced Modalities
Expanding biologics delivery beyond injections remains a high-risk, high-reward frontier, particularly in the fast-growing glucagon-like peptide-1 (GLP-1) receptor agonist market. Oral and inhaled formulations promise greater convenience but face significant scientific barriers, especially for peptide delivery. Bend Bioscience is taking a multidisciplinary, technology-agnostic approach to address these challenges.
“There’s no silver bullet,” said Bend’s Chief Scientific Officer, David Vodak, PhD. “[We are] uniquely set up to have a flexible technical approach here where we're able to mechanistically understand where the absorption comes from and then bring different particle engineering and formulation technologies to bear to the intermediate and the dosage form to select the right approach.”
For cell and gene therapies (CGT), analytical support can be complex and specialized infrastructure may be necessary, emphasized Elena Dukhovlinova, Senior Principal Scientist at Alcami. As CGT evolves, validating niche lab equipment and ensuring regulatory compliance remain challenging, underscoring the importance of diverse analytical tools, robust data management, and frequent testing.
“To summarize, with all the complexities related to CGT cell assays, we need to carefully consider cell line and control cell selection, cell bank qualification, master cell bank and working cell bank management, qualification stability and supply management of custom analytical regions, there usually are a lot of these, and detection antibodies, FBSS standards and controls,” Dukhovlinova asserted. “The ideal assay needs to consider consistency and reproducibility, correct system suitability criteria set for every step, and sensitivity and detection limits of key parameters.”
The Importance of Collaboration and Innovation
Collaboration in biotech is of the utmost importance, especially when seeking to overcome hurdles related to advancing novel treatments, confirmed Jennifer Michaelson, CSO of Cullinan Therapeutics. Highlighting her company’s work with MIT on the CLN-7 oncology program, Michaelson stressed that innovation often comes down to strong personal relationships and trust, both internally and with external partners.
“Our central core value is our impact on patients and their families,” Michaelson said. “We're not in the business of making drugs that are only going to be incremental. We want to develop medicines that are going to be transformative for patients and diseases that can have real impact.”
The company actively involves patient advocacy groups early in development, including during phase one protocols, to ensure patient insights shape clinical programs to demonstrate that communication and patient engagement are vital at every stage, benefiting both autoimmune and oncology programs.
When looking to the future of biologics, Judy Chou, President and CEO of AltruBio, emphasized that while digitalization and AI are accelerating drug development, significant challenges remain in scaling biologics and advanced therapies like monoclonal antibodies and cell/gene therapies. She predicts immunology and inflammatory diseases as areas where biologics will continue to make the most impact, followed by oncology and rare diseases, where biologics’ specificity is crucial.
Additionally, she noted that while cardiovascular, metabolic, and neurobiological diseases present opportunities, biologics may take longer to have a transformative effect there, with peptides and small molecules leading current advances. Chou concluded that ongoing innovation and talent will be essential to address the increasing complexity and unmet medical needs in these fields.
Ensuring Continued Progress
To round off the event, a key innovator’s panel discussion focused on the challenges and opportunities in early-stage drug discovery, particularly in biologics. Key themes included the critical role of academic-industry partnerships to foster innovation, with panellists highlighting how cuts in public funding threaten the talent pipeline, research continuity, and the pre-competitive academic space that drives foundational discoveries. The importance of academic incubators and postdoctoral teams was stressed, as they serve as engines for new ideas and entrepreneurial ventures.
Technological innovation — especially the integration of AI — was a central topic of debate, with the panel envisioning a future where AI becomes ubiquitous in life sciences, driving personalized medicine and precision oncology. Panellists discussed the promise and pitfalls of both predictive and generative AI in drug development yet were keen to highlight potential pitfalls such as data silos, validation complexities, and the risk of “garbage in, garbage out.”
Overall, the Advancing Complex Biologics Day showcased a sector in rapid evolution, driven by scientific ingenuity. Breakthroughs in automation, AI, and manufacturing are rapidly expanding what’s possible, but ultimately, the discussion called for sustained investment in innovation ecosystems to ensure continued progress and societal benefit.
References
Future Market Insights. Biologics Market: Biologics Market Analysis Growth & Forecast 2025 to 2035. Market Research Report, Jan 9, 2025.
Fierce Biotech. Advancing Complex Biologics into Real Treatments: Technologies, Experts, and Partners to Know in 2025. Virtual Event, April 9, 2025 (available on demand).