Contract manufacturing of commercial products of gene and cell preparations (CMO business)

Manufacturing of commercial gene and cell products in facilities compliant with J-GMP and PIC/S GMP.

・Support consultation and consulting
・Implementation of technology transfer
・Development and provision of SOPs of manufacturing and QC tests
・Maintenance of GMP documents such as deviation and change control
・Establishment of SOPs for filling tests and various validations
・Establishment of material equipment and facilities and documentation
・Material receiving and inventory control
・Planning and scheduling of manufacturing of commercial products
・Implementation of manufacturing, transportation and shipping, etc.

Process development of gene/cell preparations and contract manufacturing of investigational products (CDMO business)

Development of manufacturing processes (process development) and manufacturing of investigational products related to the seeds of CGT products for domestic and foreign pharmaceutical companies and bio-ventures.

・Support consultation and consulting
・Consulting including GMP/GCTP gap analysis
・Development of experimental protocols and manufacturing SOPs for a variety of cell types
・Construction of closed manufacturing system and introduction of automated culture equipment
・Consulting for introduction of electronic integrated system
・Construction and maintenance of SOPs of manufacturing and QC tests
・Implementation of manufacturing of investigational products, etc.

Contracted quality control testing of CGT products

Contracted quality control testing in accordance with the Japanese, EU or US Pharmacopoeia and GCTP/GMP for the manufacture of regenerative medical and CGT products.

・In-process monitoring and shipping inspections

・Aseptic testing (BAC-T method, direct method)

・Endotoxin testing

・Inspection using FCM (cell surface antigen analysis, etc.)

・Product-specific quality control testing (differentiation experiments, CTL analysis, etc.)
・Preparation and submission of quality inspection reports, etc.

Integration Development, sales, and service business of manufacturing management systems

Practical application of an integrated manufacturing management system to promote efficient manufacturing of CGT products.

・Development of an integrated manufacturing management system that integrates information on the
    manufacturing process of CGT products

・Marketing to pharmaceutical companies, CMOs, etc., and established a support system to collaborate with them.

・Promote the integration of information by integrating manufacturing and QC information with IoT and information
    integration including the supply chain.

Consulting for manufacturing of gene/cell preparations

Provide comprehensive consultation on manufacturing and commercialization of gene/cell preparations.

・Practical consulting for manufacturing investigational products and commercial products related to the seeds of
    gene/cell preparations for our clients.
・Consulting on development of automated culture equipment and integrated manufacturing systems
・Gap analysis under PICS/GMP and J-GMP control
・Training of manufacturing, quality control, and quality assurance team members for clinical trials and commercial
・Practical and practical consulting (manufacturing, quality control, quality assurance) by experts (PhD and Master's
    degree holders) based on their experience in commercial manufacturing of gene and cell products, etc.