Revolutionary treatments like cell and gene therapies offer hope to patients. Yet the manufacturing infrastructure required to deliver these innovations lags. For many patients, such therapies remain out of reach because how biologics are made hasn’t kept pace with discovery. Closing the gap requires fundamentally rethinking cell therapy manufacturing.
The Gap Between Discovery and Delivery at the New Frontier of Medicine
The shift from small molecules to living therapies has redefined what’s possible. The question is less “What are biologics?” than how living, variable therapeutics can be produced reliably at scale.
As of January 2026, there were 25 FDA-approved cell and gene therapies with 438 more in development across the U.S. Biologics include personalized treatments that target disease at the molecular level. Producing biologics vs. small molecules is challenging because biologics are manufactured in living systems where slight variations in conditions can alter the final product. Their patient-specific nature creates unprecedented manufacturing complexity.
The world’s first personalized CRISPR treatment demonstrates both the promise and the challenge. Developed for an infant with a rare genetic urea cycle disorder, a process that would typically take 18-24 months was compressed into less than six months. The therapy corrected a mutation in a gene that detoxifies ammonia, work that would have been impossible with traditional pharmaceuticals.
According to Sandy Ottensmann, VP/GM of Gene Writing and Editing at IDT, a Danaher company involved in the groundbreaking therapy, “We’re just at the beginning of what’s possible. This isn’t just about one breakthrough or one patient; it’s about building a platform that can deliver personalized cures on demand, for thousands of diseases that still have no treatment.”
The Biomanufacturing Bottleneck
The question of what biomanufacturing is becomes operational and about how living systems are controlled, scaled and validated for clinical use. Chemistry, Manufacturing and Controls (CMC) issues represent a significant barrier to getting therapies to patients. Regenerative medicine accounts for approximately 40% of all NIH clinical trial holds, despite making up around 2% of overall trials. Of those holds, about 25% are related to CMC challenges.
The Scale-Out Challenge
Traditional biomanufacturing relies on scaling up production in massive bioreactors. That model works for biologics produced in large batches but fails for therapies unique to each patient. Cell therapy manufacturing demands a different approach, scaling out rather than up, producing many small batches with consistent quality and sterility.
The complexity multiplies when the product itself is a living cell. Each batch requires precise environmental control — temperature, pH and nutrient levels — throughout the process. Quality control involves verifying biological function and viability, not just chemical composition.
Infrastructure Constraints
Infrastructure compounds the problem. Building conventional biomanufacturing facilities requires billions of dollars and years of development time. A single facility might serve one therapeutic program.
When that therapy needs modification or a new patient-specific variant, the entire production process must be revalidated in a timeline measured in months or years. These centralized plants are poorly suited to the new therapeutic landscape where personalized biologics treatments need different production models.
“The hope is that automated and closed system manufacturing of cellular therapy products can address some of these current manufacturing obstacles,” noted Peter Marks, Director of CBER at FDA, at a 2024 forum on regenerative medicine.
The Solution: Agile, Localized and Digitally-Enabled Cell Therapy Manufacturing
The path forward requires reimagining how biologics are made. Chief Science Officer at Danaher, Jose-Carlos Gutiérrez-Ramos, frames the transformation clearly. “To support new therapeutic modalities, there will need to be a proliferation of small-scale facilities to produce them. Shifting manufacturing to smaller, more localized facilities doesn’t just make manufacturing more feasible. It also speeds development and reduces the cost, making them more accessible to more people.”
This shift toward modular, distributed production replaces massive centralized plants with flexible “factory-in-a-box” concepts. Decentralized biomanufacturing brings production closer to patients while automation and digital systems manage workflow complexity at scale. Real-time monitoring and data analytics enable process optimization while reducing human error and contamination risk inherent in manual operations.
Technology Enabling the Shift
These efforts are powered by companies like Cytiva, a global biopharma company within the Danaher group, which develops the underlying bioprocessing technologies and automated systems that agile manufacturing needs.
This includes filtration systems and chromatography columns used to purify biological products, as well as bioreactors where cells grow and produce therapeutic proteins. The impact such innovations can make is substantial. In 2024, over 90% of global monoclonal antibody production was supported by Cytiva’s technologies.
An Ecosystem Approach to Unlocking Cures
Technology alone won’t solve the manufacturing paradox. Biologics vs. small molecules requires more collaboration. The biological complexity and regulatory requirements demand shared protocols and validation frameworks that no single entity can develop in isolation. Partnerships between technology providers, academic research centers and regulatory bodies are essential.
Standardizing Innovation
A powerful example is the “CRISPR Cookbook,” an initiative developed by Danaher in partnership with the Innovative Genomics Institute and the Chan Zuckerberg Initiative. This comprehensive guide standardizes the protocols and components for creating CRISPR-based therapies, helping to dramatically shorten development timelines and simplify regulatory pathways. Democratizing this critical knowledge breaks down barriers and ensures the entire field can move forward together, turning isolated breakthroughs into accessible biologic treatments.
The momentum is building. In 2025, there were around 250 active trials worldwide with a projected 20% annual growth rate through 2034. Experts predict that gene therapy will transition from an emerging technology to a mainstream practice in medicine in the next decade. Addressing the biologics manufacturing paradox will be crucial for success.
The Dawn of a New Era in Medicine
The biologics revolution has arrived. Scientific innovation has delivered therapies that were once considered impossible. The challenge now is building the biomanufacturing infrastructure to match that innovation through flexible, distributed production models that can deliver personalized medicine at scale. That’s how the gap between discovery and delivery narrows, enabling the promise of biologics to become a practical reality.
