August 2026 brought a jolt to cell and gene therapy. Bristol Myers Squibb pulled out of its $380 million manufacturing pact with Cellares, blaming the Cell Shuttle platform for falling short on commercial Breyanzi production. Industry sources say Cellares failed to hit the bar for large-scale manufacturing. No one has confirmed if regulators forced the split or if both sides planned to fix the problems. The reversal landed hard after years of expansion and hype around autologous models. Safety setbacks and commercial headwinds were already piling up.
Inside the Phoenix convention center at the 2026 Cell and Gene Meeting on the Mesa, the mood turned from optimism to hard-nosed recalibration. Executives and scientists faced a new reality: the era of one-off, patient-specific therapies is fading. Companies now chase platforms that can serve more patients and lower risk. The autologous cell therapy model, once the pride of CDMOs, faces tough questions as firms look for broader impact.
In October 2026, independent manufacturers of cell and gene therapies formed the ACGMP alliance to support developers from early process development through to commercial-scale production, covering a wide range of modalities including autologous and allogeneic cell therapies, viral vectors, RNA, lipid nanoparticles, plasmid DNA, and apheresis starting materials.
From Bespoke to Broad: Rethinking the Business Model
Jodi A. Cook, PhD, CEO of Skylark Bio, has seen the sector’s wild swings up close. “The industry exploded on new money for a while,” Cook said. “And then it stopped. Now, we’re back to being mission-focused with sound business fundamentals to drive products forward.” Cook’s new playbook is blunt: raise enough cash to reach first-in-human trials and show strong data before chasing more funding. Skylark’s inherited hearing loss program shows the shift. Instead of customizing for each GJB2 mutation, Skylark delivers a full working gene, targeting the 15% to 30% of inherited hearing loss tied to GJB2. “We’re replacing the whole gene, so we don’t have to slice and dice to personalize it to you,” Cook said. Skylark reuses capsids, manufacturing steps, and analytics across programs. That move cut the second indication’s timeline to 18 months, down from three and a half years. The aim: make gene therapy pay off by building on platform efficiencies, not starting from scratch for every patient.
Others are taking a similar tack. Nanoscope Therapeutics is sidestepping the genetic maze of inherited retinal dystrophies by delivering a synthetic, chimeric opsin to bipolar cells, turning them into light sensors. “If you don’t have functional photoreceptors, it may not matter which disease caused it,” said Samarendra Mohanty, PhD, Nanoscope’s president, CSO, and co-founder. Their MOGENRY therapy, now under priority review by Japan’s PMDA, expresses a protein built from two algae and a sea anemone—the most synthetic gene sequence yet tested in humans. COO Paul Hallen calls it “hijacking the bipolar cells to make them de facto photoreceptors.” Unlike the Nobel-winning optogenetics work of Karl Deisseroth, Peter Hegemann, and Georg Nagel, Nanoscope’s approach aims for broad light sensitivity, not single-wavelength targeting. Regulators are watching closely, with MOGENRY’s data in retinitis pigmentosa and Stargardt disease now under review.
Prime Editing and the Pursuit of Differentiation
Allen Reine, MD, CEO of Prime Medicine, sees the future hinging on differentiation and real unmet need. “Are we solving a problem that others can’t by doing that? Probably not,” Reine said, brushing off the idea of chasing crowded targets like PCSK9. Prime is betting on its prime editing platform to tackle diseases with clear clinical and commercial gaps. The company’s Wilson’s disease program, focused on the H1069Q mutation, just dosed its first patient in a global Phase I/II trial. Its Alpha-1 Antitrypsin Deficiency (AATD) program, aimed at a mutation found in up to 98% of patients, is next in line. Reine expects clinical results for both liver programs in 2027. Preclinical data in lung and cystic fibrosis point to more expansion. “I strongly believe we can ultimately show that there are good business models behind these therapies in many cases,” Reine said. When clinical and commercial interests line up, he argued, the sector can finally deliver cures at scale.
Some firms are still reeling. Cellares, once hyped as an “Industry 4.0” force in autologous cell therapy manufacturing, is regrouping after the BMS deal collapse. CEO Fabian Gerlinghaus is blunt: “Losing BMS was a setback, but BMS does not define the company.” Since the split, Cellares has doubled its customer base and now targets a portfolio of 30 to 40 active autologous ex vivo programs. The company also landed a spot in the FDA PreCheck program, joining eight firms—including Eli Lilly and Regeneron—granted accelerated facility inspections before commercial launch. Gerlinghaus, less brash than in past years, admits the setback stung: “Now we’ve had a setback. But show me one company that never had a setback.”
At the 2026 Cell & Gene Meeting on the Mesa, FDA CBER director Karim Mikhail emphasized that manufacturing processes suitable for early clinical trials may not be adequate for commercial scale-up and validation, highlighting the regulatory focus on designing production with future commercial capacity in mind.
Industry at a Crossroads
Reversals are nothing new in this field. Between 2024 and 2026, safety alarms stopped Sarepta’s Elevidys after acute liver failure deaths, and Novartis’s Zolgensma hit a commercial ceiling. The Cellares-BMS breakup is just the latest in a string of high-stakes pivots. As BioPharm International reported, Caribou Biosciences, ArsenalBio, TScan Therapeutics, and Cellectis all pulled out of ex vivo cell therapy programs in 2026. Cellectis pointed to shrinking commercial prospects as rivals rolled out stronger first-line therapies and bispecific antibodies.
The 2026 Cell and Gene Meeting on the Mesa made one thing clear: the sector is moving past bespoke medicine. Scale, platform reuse, and commercial discipline now set the pace. Companies that can cut timelines and deliver therapies for broader groups have a shot at surviving the next shakeout. Those stuck on hyper-personalized, one-off treatments risk falling behind. The last word belongs to the firms that adapt and execute as the market resets around them.
