Founded in 2011, Tanvex BioPharma USA has been perfecting our skills in making biologic therapeutics more accessible to patients. To-date, we have successfully brought our first product to approval and two additional BLAs pending FDA approval. Our journey is defined by an unwavering commitment to excellence, innovation, and a passion for revolutionizing healthcare. We are now offering our technical and operational expertise to a greater audience by becoming a Contract Development and Manufacturing Organization – Tanvex CDMO.

Nestled in the Sorrento Valley of San Diego, our 100,000 square feet, state-of-the-art campus serves as the nucleus of our operations. With Research and Development, and GMP manufacturing all under one roof, we foster smooth collaboration, maximizing efficiency at every step of the drug development process from pre-clinical to commercialization for both microbial and mammalian derived biologics. At the heart of Tanvex CDMO is our dedicated team of over 160 skilled professionals who bring unparalleled expertise to every project. Innovation thrives at Tanvex CDMO where we offer a comprehensive suite of services including:

●	Cell line development (mammalian and microbial)
●	Microbial fermentation process development and optimization
●	Mammalian cell culture process development and optimization 
●	Pre-formulation and drug product formulation development
●	Analytical development, method qualification/validation
●	QC lot release testing & Stability study 
●	Clinical to Commercial GMP manufacturing (mammalian and microbial)
●	Regulatory support

From high-throughput (HT) workflows for process development to streamlined equipment for seamless process transfer to GMP production, coupled with single-use technology in our GMP manufacturing facilities, we are ready to advance your molecule to the next stage. Together, let's deliver groundbreaking advancements in biopharmaceuticals and make a lasting impact on healthcare worldwide.

Biotechnology

Pharmaceutical

Therapeutics

Tanvex CDMO

Henry Chen

Norma Braun

Kevin Yeh

John Mosack

The Quality Assurance and Process Development team at Tanvex CDMO is dedicated to ensuring that all biopharmaceutical products meet the highest standards of quality and compliance throughout the development and manufacturing process. This team collaborates closely with scientists and engineers to design and optimize processes, validate analytical methods, and implement stringent quality control measures, ultimately facilitating seamless transitions from pre-clinical stages to commercial production while adhering to regulatory requirements. Their focus on continuous improvement and innovation fosters a culture of excellence, enabling the delivery of safe and effective therapeutics to patients.

Quality Assurance and Process Development

Leadership Team

Quality Assurance and Process Development

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Leadership Team