tBrexa Bio: Pioneering Innovation in U.S. Biomanufacturing
Powering the Next Generation of Therapies – Agile Manufacturing for Early-Stage Biologics and Gene Therapies
Early-Stage Manufacturing Expertise
From Pre-Clinical to Phase 2
Accelerate your program with scalable, cGMP-ready solutions designed for early-stage biologics, gene, and cell therapies.
Integrated CDMO Services
All-in-One Development Partner
From process development to analytical testing and fill-finish—our end-to-end services reduce complexity and speed up timelines.
Built for Innovators
Flexible. Responsive. Startup-Focused.
As a woman and minority-owned CDMO, we partner with emerging biotech to bring transformative therapies to life.
who tBrexa Bio is, what WE stand for, and what makes us unique
Turning Possibility Into Progress for the Patients Who Need It Most
tBrexa Bio is built to accelerate innovation for therapies that matter most. As a next-generation CDMO, we specialize in bringing complex biologics, gene, and cell therapies from concept to clinic—empowering breakthroughs for patients with rare and underserved diseases. Our mission is to turn possibility into progress, transforming bold science into real-world impact.
Innovative Regulatory Science Group
Partnership with Regulatory
What sets tBrexa Bio apart is our foundation in regulatory excellence. Through our partnership with Innovative Regulatory Science Group (IRSG), we bring deep expertise in global regulatory strategy and clinical development into every manufacturing decision. This synergy ensures our clients move faster, with confidence, navigating early-phase milestones and complex therapeutic pathways with precision and purpose.
Manufacturing Capabilities
