As the biotech industry reflects on the recent J.P. Morgan Healthcare Conference, attention is turning from ambitious projections to the practical challenges of manufacturing complex biologic drugs. The 2026 outlook for drug development is marked by promises of AI-driven discovery and rapid progress in tackling difficult targets, but industry leaders are emphasizing the importance of having a robust and flexible manufacturing toolkit.
Manufacturing these advanced molecules requires more than new technology; it calls for experienced contract development and manufacturing organizations (CDMOs) that can adapt their processes to meet the unique needs of each product. Industry experts note that relying on a single approach may no longer be effective given today’s regulatory demands and diverse pipelines.
Kasper Møller, Chief Technical Officer at AGC Biologics, explained, “We are acutely aware of the pressures our customers face: the need to innovate with increasingly complex molecules, and the simultaneous demand to get to the clinic faster and more cost-effectively than ever before. Our partnership with ATUM is a direct response to that need. We are not just adding a new technology; we are providing our customers with more options and flexibility.”
For standard monoclonal antibodies, established platforms like AGC Biologics’ CHEF1 offer a track record of supporting approved products, giving developers confidence in regulatory submissions and predictable outcomes. In contrast, for more complex molecules such as bi- or trispecific proteins, platforms like ATUM’s Leap-In can help accelerate process development by generating stable cell pools quickly—a capability valued by both developers and regulators seeking thorough process understanding.
ATUM co-founder Claes Gustafsson highlighted this focus: “We developed the miCHO cell line and Leap-In Transposase to improve expression robustness, maximize efficiency and increase speed to clinic. The platform was designed with complex biologics manufacturing in mind. The combination of our enabling technology with AGC Biologics’ deep manufacturing expertise will create an exceptional offering for the industry.”
As companies navigate an uncertain business environment in 2026, strategic choices about manufacturing partners—based on flexibility and technical know-how—are expected to play a critical role in transforming scientific breakthroughs into approved therapies.
Sponsored content is written and provided to BioSpace by the advertiser. It is published with the advertiser’s approval without contribution from BioSpace’s editorial and insights teams.
