Office of Translational Production & Quality

Daniel Kota, PhD

Director, Office of Translational Production & Quality

The Office of Translational Production & Quality is responsible for the strategic and operational planning, successful execution and management of all translational quality assurance and manufacturing functions within the Houston Methodist Research Institute. Our office is additionally responsible for establishing policies, objectives and plans to articulate vision and commitment to quality and for implementing and maintaining robust Quality Systems to support translational projects at HMRI.

The cGMP Core, comprised of Quality Assurance, Quality Control and Quality Operations, serves as the Quality Unit for the Office of Translational Production & Quality at the Houston Methodist Research Institute. Our mission is to provide internal investigators and external academic or industry partners with a cGMP compliant and cost-effective route to translating novel therapeutics and devices to the clinic.

Most academic institutions and small biotechnology companies outsource GMP manufacturing to contract manufacturing organizations, which can be very costly and time-consuming. Our infrastructure is designed to provide not only the Quality Systems, facilities and equipment for cGMP manufacturing and release, but also the expertise to guide and implement GMP protocols for investigators who may be less experienced in the process.