Our History
Founded in 2001, Title21 was named after Title 21 of the Code of Federal Regulations, which governs the U.S. food and drug industries. From the beginning, the company helped healthcare and life sciences organizations manage complex regulatory requirements and maintain high standards of compliance and quality.
Over time, Title21 expanded its platform to support cellular therapy laboratories, blood and marrow transplant programs, and biotherapeutic manufacturers. Today, the company provides digital solutions to streamline documentation, improve compliance, and support regulated operations at leading healthcare institutions.
A major milestone came in 2026 with the acquisition of MyCellHub, a manufacturing execution system (MES) for advanced therapy manufacturing. Adding MyCellHub expanded Title21’s capabilities to include real-time production monitoring, digital batch records, and embedded quality management in manufacturing operations.
Together, these capabilities position Title21 as a single-source digital platform connecting quality, manufacturing, and clinical workflows across the advanced therapies ecosystem. This helps organizations reduce risk, improve efficiency, and accelerate the delivery of life-saving therapies to patients.
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Our Mission
Title21 believes biotherapies are the future of medicine and the industry needs higher quality and better access to tools and data to discover and deliver cures to patients. Our role is to design and implement software that bridges the gap between clinical practice, laboratory science, and therapeutic manufacturing, empowering our customers to serve patients with quality, efficiency, and kindness in mind. Ultimately, Title21 is proud to enable and enhance the execution of workflows and the collection and presentation of data that lets our customers tell their stories and serve their patients.
Our Commitment to the Future
As the healthcare landscape continues to evolve, Title21 remains committed to being at the forefront of innovation. We are dedicated to investing in research and development, expanding our product offerings, and partnering with healthcare organizations to create a brighter, healthier future for all.
Join Our Team of Innovators
We're a community of problem-solvers and collaborators dedicated to bringing innovative software solutions to patients globally. If you're ready to use your unique talents and make a real impact, explore our open positions and discover a career where your contributions truly matter.
