Lonza To Develop, Manufacture TcL Candidate

TcL Pharma and Lonza have signed a development and supply contract for TcL Pharma’s lead drug candidate, a monoclonal antibody that adjusts the immune system for the potential treatment of graft rejections and patients with auto-immune diseases.

The long-term service agreement includes strain development using Lonza’s XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material. The first phase of the project will involve strain development using Lonza’s E. coli expression technology, followed by microbial process development and optimization activities to help achieve the highest yields possible. Pending certain project milestones, Lonza will then produce the bulk drug substance in its 1,000 L microbial biopharma facility in Visp, Switzerland for toxicology studies and a Phase I trial.

“We choose Lonza for their extensive know-how and experience in the development and scale-up of microbial biopharmaceuticals,” said Maryvonne Hiance, president of TcL Pharma. “We look forward to working with such a trusted name in custom manufacturing and are confident that it will lead to positive results.”