TCL Pharma Selects Lonza to Develop, Manufacture Top Drug Candidate

The long-term service agreement includes strain development using Lonza’s proprietary XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material.

05/03/09 TcL Pharma and Lonza have recently signed a development and supply contract for TcL Pharma’s lead drug candidate, an innovative monoclonal antibody that adjust the immune system, and a compound that would treat graft rejections and help patients with auto-immune diseases, if approved.

The long-term service agreement includes strain development using Lonza’s proprietary XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material.

“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.”

The first phase of the project will encompass strain development using Lonza’s patented E. coli expression technology, followed by microbial process development and optimization activities to help achieve the highest yields possible, increase speed to market, and lower the total cost of goods. Subject to several project milestones, Lonza will then produce the bulk drug substance in its state-of-the-art 1,000 L microbial biopharma facility in Visp, Switzerland for toxicological studies and a phase I clinical trial.

“We are looking forward to a long-standing relationship with a promising, innovative company developing new therapies for patients in need,” said Dr. Stephan Kutzer, Head of Lonza Biopharmaceuticals.

TcL Pharma’s compound, a PEGylated anti-CD28 Fab, is a therapeutic antibody fragment designed to selectively inhibit T-cell responses against grafts. The molecule is a novel antagonist of the human CD28 receptor, an important co-stimulatory protein expressed on T-cells. Promising preliminary results indicate that this molecule will be administered for the treatment of graft rejection and auto-immune diseases.