tBrexa Bio
tBrexa Bio
tBrexa Bio operates under a hybrid, agile model focused on R&D: process development, cell line optimization, and analytical method development for monoclonal, bispecific, and trispecific antibodies and other large‑molecule therapeutics. We combine in‑house expertise with strategic partners to scale as needed while aligning to regulatory expectations.
Upstream and downstream development with DoE, scale‑down models, and comparability planning for antibody programs (mAb, bsAb, tsAb) and other large molecules.
Cell line screening and optimization for titer, quality, and stability; media/feed strategy; early scale‑up guidance.
Immunoassays (e.g., ELISA), molecular assays (qPCR/ddPCR), and bioanalytical methods for identity, purity, binding, and potency to support characterization and comparability.
Data packages, draft control strategies, and transfer plans that de‑risk future GMP transitions with our partner network.
Documented SOPs, data integrity (ALCOA+), and traceability in a controlled lab environment to align with regulatory expectations.
Clear milestones, regular updates, and transparent dashboards for scope, timelines, and deliverables.
Our hybrid model blends tBrexa’s in‑house R&D with a vetted network of partners to carry programs beyond our current scope. This lets clients move from research to clinical stages without losing speed or context.
Access trusted CDMOs for DS/DP manufacturing and clinical supply. We coordinate knowledge transfer to protect your timelines and right‑first‑time outcomes.
Tap external cores and CROs for advanced characterization when needed (e.g., orthogonal methods, high‑resolution analytics).
University cores and innovation hubs extend capacity and accelerate feasibility work without heavy fixed overhead.
Through Innovative Regulatory Science Group (IRSG), our sister firm, we align development activities with evolving global regulatory expectations — reducing risk and rework later.
Regulatory roadmaps, meeting prep, briefing packages, and responses that reflect process reality and data readiness.
Authoring and review of CMC sections, phase‑appropriate controls, and realistic commitments that enable efficient scale‑up.
Part 11 considerations, change control and CAPA frameworks, and inspection preparedness woven into operations.
As a woman‑ and minority‑owned company, we invest in the next generation of scientists. Our partnership with Inner City Academic Achievers provides STEM apprenticeships, mentoring, and hands‑on learning for students from underrepresented communities — building a stronger, more inclusive life‑sciences workforce.
Lab exposure to early‑stage biologics workflows and analytical methods.
Career pathways in biotech, regulatory affairs, and entrepreneurship.
Real‑world skills that feed regional life‑sciences talent needs.
Questions? Email info@tbrexa.com.
Prefer a guided intake? If you’d like our Business Development team to reach out, please complete our
Project Intake Form.
After you submit the intake, our BD team reviews within 1–2 business days and routes to the right expert. We’ll propose a phased plan for non‑GMP R&D and outline GMP partner pathways if needed.