As biopharma pipelines shift toward complex therapeutic modalities, traditional cell lines and legacy outsourcing models are reaching their limits. To understand how specialist service providers are redefining the biomanufacturing ecosystem through targeted innovation, optogenetics, and dynamic process control, The Pharma Navigator sat down with Christelle Dagoneau, Ph.D., Chief Business Officer at Prolific Machines.
Evolving Expectations
TPN: How has the shift in industry toward complex modalities transformed sponsor expectations when evaluating external service providers compared to traditional small or large molecule outsourcing?
Dagoneau: This indeed has been a major shift as over half the pipeline is now some form of complex molecule such as: multispecifics, fusion proteins, cytokines and more. And the expectations from sponsors have evolved accordingly: can you handle the products in my complex pipelines from process, analytical and clinical manufacturing standpoint? In the field of biologics manufacturing, traditional cell line development and expression systems struggle with these novel formats, and the sponsors are actively looking for new solutions.
A Need for New Tech
TPN: What specific technical capabilities, analytical tools, or platform technologies allow a service provider to genuinely stand out in the current market?
Dagoneau: These days it’s about both ‘developability of the molecule and scalability of the manufacturing process! Can your partner help develop the right cell line to get you to the clinic, produce enough material for your clinical journey and then carry the process through IND, late-stage and commercial supply? This has become straightforward for standard monoclonal antibodies, but that’s no longer the case for novel formats. New technologies are needed to provide sufficient control, quality, and yield for the next-generation biologics. Prolific Machines’ optogantibodies platform, which uses light to control cell expression in the cells and deliver breakthrough productivity, has been in much demand lately precisely to address this issue.
Seamless Scale-Up
TPN: How can specialized CDMOs and CROs demonstrate proactive problem-solving in process development and analytical testing early on in the drug lifecycle to prevent costly delays during late-stage scaling or commercialization?
Dagoneau: The most costly problems at Phase 3 are usually built in at the cell line stage: a titer that can’t support commercial COGS, or quality attributes that were never really under control. So, the proactive move is to solve them early. Get the chain pairing, glycosylation profile and productivity right at the cell line stage, rather than reworking the process later. Scale-up should then be as seamless as possible, on the same system and on existing equipment, to avoid cost and complexity. Prolific’s platform is designed to integrate into existing bioreactor infrastructure, so a process can move from benchtop to whatever scale the product needs.
Significant Improvement with Digital Tools
TPN: Where do you see digital innovation offering a clear competitive advantage for specialized service providers, and where is the market still struggling to see real value?
Dagoneau: That’s a great point. New digital and AI tools are already enabling significant improvement in biologics development, analysis and manufacturing Where the market struggles is turning that data into action. Most processes are data-rich but lever-poor: today’s levers, such as media, feeds, temperature and pH, act indirectly on the cell and are largely fixed once the recipe is set. By coupling optogenetics with AI-driven closed-loop control, Prolific turns light into a tunable process parameter. Light acts directly on cell behavior and can be adjusted in real time, cutting the number of experimental cycles needed to reach a robust process.
A Splintered Landscape
TPN: How can niche or boutique specialized providers maintain a distinct value proposition and defend their market position over the next three to five years?
Dagoneau: We are seeing in the market the splintering of CDMO service models at this point. Some very large CDMOs are continuing to offer comprehensive solutions, but many are now specializing in end-to-end services for specific modalities or dose forms, and some are providing very niche specialized solutions that mainstream players are not interested in given the stage or the scale. Prolific is working with several CDMOs to incorporate our technology at their existing facilities to their clients can take full advantage of integrated services at the right scale using the new technology. We believe that this is the fastest path to new technology adoption and would deliver the best service to innovators.
Innovation is Key
TPN: Looking ahead, what advice would you give to biopharma teams trying to bridge the gap between breakthrough science and commercial manufacturing?
Dagoneau: Translating scientific breakthroughs into manufacturable medicines requires process and manufacturing innovation at every step of the value chain, and that innovation is increasingly driven by specialists like Prolific Machines across a growing range of modalities. My advice is not to treat speed to clinic and commercial COGS as a trade-off. Too many programs reach the clinic on a conventional toolkit and arrive at Phase 3 with a process that was never designed for commercial cost. Sponsors are evaluating many approaches, so what matters is delivering innovation backed by validation and data. That’s what the Prolific team has been focused on: the platform recently delivered a record 21 g/L mAb titer, and we are now working hand in hand with biotechs, top-tier pharma, CDMOs and global health foundations, both to scale the manufacturing platform and to advance next-generation biologic candidates. This is the key to delivering better treatments for patients waiting for them.
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