The collaboration comes as Japan turned over a new leaf as far as regenerative medicine last fall. The country passed a new law, the Revised Pharmaceutical Affairs Act, which grants conditional approval to a regenerative medicine when clinical safety and efficacy are demonstrated. Experts expect Japan to be at the forefront of the clinical application of cell and gene therapy products.
The companies said the global reach of the regenerative medicine market and the advancements in stem cell manufacturing have driven this collaboration. Nikon is likely to benefit from Lonza’s track record in cell manufacturing and it will acquire the technical know-how to differentiate and manufacture cells, including somatic stem cells.
Lonza will not have any ownership of the Nikon facility “but rather support in the training of personnel and provide access to Lonza’s operating procedures and facility design,” Lonza spokeswoman Colleen Floreck told Outsourcing-Pharma.com.
She added: “There are a few competitors (Takara Bio, Fujifilm, and Japan Tissue Engineering) in the contract cell manufacturing space in Japan, however Lonza is the recognized world leader in cell therapy manufacturing, producing many times more than current competition in Japan.”
The Japanese market for gene and cell therapies is expected to be worth 170bn yen ($1.42bn) in 2030 and 420bn yen ($3.51bn) in 2050, Floreck said.
The Tokyo/Yokohama area of Japan is currently under consideration for the site location of Nikon’s new facility.
Andreas Weiler, Head of Emerging Technologies, Lonza Pharma & Biotech, added: “We are utilizing our expertise built over the last decade to work together with Nikon in bringing high-quality, innovative development and manufacturing to Japan. Because of its work in iPSC [induced pluripotent stem cell] technology, we believe Nikon is an ideal partner for this collaboration in regenerative medicine.”
Nikon also plans to develop equipment and disposables needed to optimize the manufacture of high-quality cells, along with hardware and software from Japan to the international market.
“Lonza will be able to work closer with Japanese regenerative medicine customers who will initiate production at the Nikon facility and then progress into world market,” Floreck added. “This need for additional capacity will allow them to transition into an existing larger-scale Lonza Cell Therapy facility with minimal technology transfer.”