The cell and gene therapy (CGT) sector is entering a phase of more disciplined and sustainable growth after years of volatility, according to industry leaders speaking at the 2026 Biotech Showcase in San Francisco. During the Alliance for Regenerative Medicine’s (ARM) annual State of the Industry briefing, ARM Chief Executive Officer Tim Hunt pointed to a recovery in financing and partnership activity as key signals of renewed confidence in the sector.

Capital inflows into CGT reached USD 11.1 billion in 2025, reflecting a rebound in investor interest alongside a growing emphasis on scalable and commercially viable platforms. As funding conditions improve, companies focused on the commercialization of cell therapies are accelerating execution across development, regulatory engagement and manufacturing.

One such company is San Francisco-based Cellares, an integrated development and manufacturing organization (IDMO) specializing in automated, end-to-end manufacturing technologies for cell therapies. The company is focused on addressing one of the sector’s biggest bottlenecks—scaling production to meet patient demand while maintaining consistent quality.

Cellares recently marked a significant milestone after the US Food and Drug Administration cleared an investigational new drug amendment submitted by Cabaletta Bio, enabling Cellares to manufacture rese-cel, an investigational autologous CAR-T therapy, for clinical trials. The therapy will be produced using the company’s automated Cell Shuttle manufacturing platform and its Cell Q quality control workcell.

This approval represents the first time Cellares’ full manufacturing system will generate good manufacturing practice drug product intended for patient infusion. The company expects first patient dosing to begin in the first half of 2026.

According to Cellares leadership, scalability is particularly critical for autoimmune indications, which typically involve far larger patient populations than oncology. The company believes its automated manufacturing approach offers a differentiated solution capable of supporting these higher-volume requirements.

Cellares’ manufacturing progress is underpinned by strong financial backing. The company’s most recent major funding round, a USD 255 million Series C, supported the development of its first commercial-scale smart factory in New Jersey. Since then, Cellares has announced additional manufacturing facilities in Japan and the Netherlands as part of a broader global expansion strategy.

The company has also secured a USD 380 million capacity reservation and supply agreement with Bristol Myers Squibb for CAR-T manufacturing across the United States, Europe and Japan.

Regulatory momentum has further validated Cellares’ approach. The FDA recently granted an Advanced Manufacturing Technology designation to the Cell Shuttle platform, recognizing its potential to reliably manufacture cell therapies at scale and reinforcing confidence in automated CGT manufacturing models.