Establishment of a GMP-compliant pilot production facility
First written in FY2016. 3 of 7 entries say "Restated". Latest entry: FY2020.
No other company in this theme has enough history to compare yet.
- FY2020RestatedAnnual report
「To achieve pharmaceutical manufacturing using genetically modified silkworms, it is also necessary to comply with regulations such as GMP. In 2016, we built the Maebashi Research Institute as a pilot plant for pharmaceutical manufacturing using genetically modified silkworms.」
The company continues to develop GMP manufacturing, strain management and manufacturing control technologies based at the completed Maebashi Research Institute. - FY2019AdvancedAnnual report
「We held a strategic consultation with the PMDA regarding the management of genetically modified silkworm strains and banks, and obtained agreement on our planned approach to (1) the generation process and strain management methods for genetically modified silkworms, and (2) quality and process control during the large-scale rearing of genetically modified silkworms and the starting point for GMP control.」
The company conducted a strategic consultation with the PMDA regarding GMP compliance based at the Maebashi Research Institute and obtained agreement on its approach to manufacturing and quality control. - FY2018-Q2AdvancedAnnual report
「We are currently using the pilot facilities at the Maebashi Research Institute to advance silkworm rearing and antibody production technology development under a GMP framework.」
The completed Maebashi Research Institute and its GMP pilot facilities are being used for silkworm rearing and antibody production technology development under a GMP framework. - FY2017RestatedAnnual report
「Capital expenditures on property, plant and equipment totaled ¥387.516 million during the consolidated fiscal year, as detailed below by segment.」
The company is reaffirming the opening of the pilot plant at the Maebashi Research Institute. Capital expenditures in the genetically modified silkworm business totaled ¥374.798 million, while ¥941.704 million was recognized as research and development expenses at the end of the fiscal year. - FY2017-Q3RestatedAnnual report
「In the genetically modified silkworm business, the GMP pilot production facility for proteins produced by genetically modified silkworms was completed in August 2016 and opened as the Maebashi Research Institute. Capital expenditures totaled ¥1,040.062 million.」
The company is reaffirming the completion of the GMP pilot production facility and opening of the Maebashi Research Institute in August 2016, with capital expenditures stated at ¥1,040.062 million. - FY2017-Q2AchievedAnnual report
「In the genetically modified silkworm business, the GMP pilot production facility for proteins produced by genetically modified silkworms was completed in August 2016 and opened as the Maebashi Research Institute. Capital expenditures totaled ¥1,038.564 million.」
The GMP pilot production facility was completed in August 2016 and opened as the Maebashi Research Institute. Capital expenditures totaled ¥1,038.564 million. - FY2016First statedAnnual report
「Establishment and equipment of a GMP pilot production facility for proteins produced by genetically modified silkworms」
The plan called for an investment of ¥1 billion, work to begin in June 2015 and completion in July 2016.