tBrexa Bio Inc.

Welcome to tBrexa Bio, an innovative start-up CDMO based in Massachusetts, dedicated to transforming the future of healthcare. Our mission is to advance the biopharmaceutical industry by providing state-of-the-art manufacturing solutions for cutting-edge therapies. As a contract development and manufacturing organization, we offer a comprehensive range of biologics manufacturing services, from process development to cGMP clinical and commercial manufacturing. Our expertise in biomanufacturing and quality control is paired with advanced capabilities in immunoassays, molecular assays, and bioanalytical methods, ensuring the highest standards in cell and gene-based therapies and large-molecule biologics production. Our services encompass clinical and commercial drug substance and drug product manufacturing, release and stability testing, and a variety of process development services, including upstream and downstream development and optimization, analytical method development, cell line development, testing, and characterization. With our planned Massachusetts facility set to open in 2025, we are poised to have a significant impact on the biotechnology sector. We are actively seeking strategic partners and funding to bring our vision to life and lead the way in biopharmaceutical innovation. 1. Manufacturing Expertise: We develop and produce clinical-grade materials, ensuring compliance with Good Manufacturing Practices (GMP) standards. 2. Regulatory Support: We have a dedicated team that will assist in preparing Investigational New Drug (IND) and marketing applications globally. We help you navigate complex regulatory pathways. 3. Commercialization Readiness: Strategic planning and technical assistance to streamline the transition from research to market, including scalability assessments and cost optimization. 4. 2025-2026 Life Science Incubator: tBrexa proposes the creation of a state-of-the-art Life Science Incubator within our newly identified facility.