ABSTRACT
Recombinant proteins have diverse medical and industrial applications. The sources of the biologics used in medicine have changed from animal tissues or human blood to recombinant human proteins because of the high safety and reliability requirements. A variety of recombinant protein production systems have been developed, but it is still difficult to efficiently produce high-molecular-weight proteins with complex structures. Silkworm can synthesize a vast amount of silk proteins in a short period of time. To utilize this capacity for mass production of recombinant proteins, a transgenic silkworm system was developed, in which recombinant proteins were synthesized in the silk gland and secreted into the cocoon. Using the system, various proteins including laminin fragment, collagen α-chain and monoclonal antibodies were successfully produced and developed as materials for diagnostic or research-use reagents, and for cosmetics. Moreover, several silkworm-produced proteins are being developed as biologics for therapeutic uses. To produce biologics, transgenic silkworms must be reared under GMP-compliant conditions. Immuno-Biological Laboratories Co., Ltd. constructed GMP-compliant facilities for producing biologics using the transgenic silkworm platform and is currently engaged in developing biologics in the pilot facility.
