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.”
Source : http://www.outsourcing-pharma.com/