Service

CDMO Service from Product Design to Commercial Production

The list of our services is below

Service Menu List

R&D consulting, Issue identification, support of product specification design, etc.

Categories	Menu overview	Details
1) R&D Consulting	Development Planning Support	We support to build a development plan suitable for clients' technological seeds, including appropriate test items and their timing. Our experienced consultants can support PMDA consultation from preparation. In addition, we support you to comply with regulations in Japan, where overseas clients have high needs.
	Supports of PMDA consultation
	Consulting of regulation in Japan, for overseas clients
2) Identification of issues in manufacturing methods	On-site assessment of manufacturing process/technology	Our engineers check clients' process on site to identify issues in manufacturing methods and propose solutions.
	Assessment of manufacturing process/technology by co-trial (Carrying out clients' process together at our sites)
3) Design of product specification	Support for setting quality specifications and safety of raw materials	We support to select raw materials per product characteristics and propose quality specifications. For biological raw materials, we can support to confirm compliance with "Standards for biological raw materials".
	Support to develop manufacturing processes	Based on product characteristics, we support the development of manufacturing processes from human cells/tissues to meet required quality specifications.
	Support for setting specifications	From the viewpoint of quality and safety, we support process inspections, inspection items, and specification setting in the manufacturing process from the acceptance of source cells/tissues to the shipment of products.
	Support for setting up quality specification tests
	Support for building transportation system	We support to develop packaging and carriers for transportation based on product characteristics as well as building of transportation systems to ensure quality and safety.
	Stability test support	We support stability testing for quality and safety.
	Manufacturing process development	Based on the product characteristics, we develop the appropriate process of manufacturing from source cells/tissues with meeting required quality specifications.
	Equivalence verification per changes in manufacturing methods	We perform equivalence verification due to changes in manufacturing methods.
4) Manufacturing of preclinical supplies	Manufacturing of preclinical supplies	We manufacture the products for preclinical studies.
	Establishment and operation of production system	Appropriate management of manufacturing and quality is required for the products of cell and gene therapy/regenerative medicine in accordance with the GCTP regulation in Japan. We build and operate an appropriate management system suitable for the client's product characteristics.
	Quality specification testing	We perform required quality specification testing per specifications of products.
5) Manufacturing of clinical supplies	Manufacturing of cell processing products	Based on the procedure manual (SOP) from a client, we work on technology transfer then manufacture cell processing products.
	Establishment and operation of production system	We build and operate an appropriate management system that is suitable for the product characteristics of each client’s product.
	Quality specification testing	We perform required quality specification testing per specifications of products.
6) Improvement of manufacturing process	Improvement of manufacturing process improvement for late-stage clinical supplies or commercial supplies	We improve/customize the manufacturing process developed during product specification design for adjusting to late-stage clinical supplies and/or commercial supplies.
7) Manufacturing process development	Development of manufacturing processes for late-stage clinical supplies or commercial supplies	We develop the manufacturing process for late-stage clinical supplies and/or commercial supplies.
	Equivalence verification per changes in manufacturing methods	We perform equivalence verification due to changes in manufacturing methods.
8) Manufacturing of clinical supplies	Manufacturing of clinical supplies	We manufacture clinical trial materials.
	Establishment and operation of production system for clinical supplies	Appropriate management of manufacturing and quality is required for the products of cell and gene therapy/regenerative medicine in accordance with the GCTP regulation in Japan. We build and operate an appropriate management system suitable for the client's product characteristics.
	Quality specification testing	We perform required quality specification testing per specifications of products.
	Support for building logistics of transportations	Since products in cell & gene therapy/regenerative medicine require rigorous temperature control due to its limited shelf-life, it is necessary to optimize the transportation system for medical institutions per each product. Through the collaboration with the logistics companies who we partner with, we can support to deliver your products to your designated destination.
	Cell bank establishment and storage	We support to establish cell banks for manufacturing, which are especially essential for allogeneic cell products, and conduct quality inspections such as microbial tests and characterization tests. The established cell bank is stored at an appropriate temperature under our management system.
9) Supports of works for regulatory submissions	Data collections required for regulatory submissions	We support and execute documentation for PMDA consultation and other regulatory interactions.
	Support documentation for regulatory submissions
	Works to regulatory inspections
10) Manufacturing of commercial supplies	Technology Transfer	We perform technology transfer including your technology, procedures, experiences and other important data to ensure successful manufacturing.
	Validation Execution	We execute verification and validation of scientific rationale to ensure stable and sustainable manufacturing of your products.
	Manufacturing of approved products	We manufacture your approved products.
	Quality specification testing for approved products	We perform required quality specification testing per specifications of your approved products.
	Establishment and operation of a production system in accordance with GCTP regulation	Appropriate management of manufacturing and quality is required for the products of cell and gene therapy/regenerative medicine in accordance with the GCTP regulation in Japan. We build and operate an appropriate management system suitable for the client's product characteristics.
	Shipment and logistics of approved products	We ship and transport your approved products from our manufacturing sites.
	Stability testing	We support stability testing to ensure quality and safety.
11) Process improvement of commercial manufacturing	Process improvement of commercial manufacturing for approved products	We work on the improvement of the manufacturing process of the your approved products.

Vector manufacturing and tests that can be handled by TFBS Bioscience, Inc.

EX: Phamacology testing, toxicology testing, characterization testing of cell banks

* TEIJIN group partners with TFBS Bioscience and they conduct the tests.

• TFBS Bioscience: Vector manufacturing services
• TFBS Bioscience: Contract tests

* These are the links to TFBS Bioscience web site.

Categories	Sub categories	Test Items/Contents
Pharmacology Tests	In vivo testing	Animal species: rats, mice, guinea pigs, hamsters
		Route of administration: Intravenous, intra-arterial, intracranial, intratracheal, subcutaneous, customized, intraperitoneal, intra-articular, intranasal, intracerebral, oral, intramuscular
		Disease Model: • Respiratory system (Chronic obstructive pulmonary disease (COPD))/Rhinitis/ Asthma) • Acute liver failure (ALF)/Inflammatory bowel disease (IBD) • Acute/chronic kidney disease (AKD/CKD) • Diabetes • Skin care (whitening effect/moisturizing effect/Hair regeneration effect) • Cardiovascular • Solid tumors • Custom models
Toxicity Tests (Safety)	General Toxicity Tests	Bio-distribution test (GLP/non-GLP)
		Genotoxicity Tests
		Local hypersensitivity test
		Tumorigenicity Tests
		Pilot toxicity studies (non-GLP)
		Pivotal Toxicity Test (GLP)
	Bioanalysis for animal testing	Clinical Observation
		Histopathology (IHC, H&E)
		Cell-mediated analysis * Primary cell culture for immunoassays
		Serology Analysis * Cell-based platform
		Titration of neutralizing antibodies * ELISA platform
Cell Bank Characterization (Mammals)	Identity test	Karyotyping
		DNA Fingerprinting
		RAPD (Random Amplified Polymorphic DNA)
	Purity Tests	Electron microscopy
		Sterility Tests
		Mycoplasma test
		Specific Virus Tests
		Virus testing (in vivo/in vitro)
		Retrovirus testing
		Mycobacterium test
	Stability Tests	Nucleotide sequence analysis
		Genetic Stability Tests
	Other Exams	Oncogenic
		Carcinogenicity
Cell bank characterization (bacteria and yeast)	-	Viable bacteria count test
		Identification testing according to API 20E
		Bacteriophage testing
		Gram staining
		Direct culture method
		RAPD (Random Amplified Polymorphic DNA)
		Antibiotic Resistance Tests
		Sequence Analysis
		Restriction enzyme mapping and copy number analysis
		Confirmation of retention of expression constructs
Virus Clearance Testing	-	-
Bulk Rot Release Test	-	-
Customized assay development and analysis for preclinical and clinical Mr./Ms.	-	-

Quality tests supported by TEIJIN Group

EX: Analytical development, cell morphology test and other confirmatory testing, stability testing

Test items	Exam content
Test method development	Development of test methods in the early stages of development
Confirmation test	Cell morphology, appearance, properties, insoluble foreign matter test, differentiation capacity (osteoblasts, adipocytes, chondrocytes)
Tests related to infectious agents	Sterility test, endotoxin test, mycoplasma negation test, human virus negation test
Safety	Cell proliferation analysis
Purity Tests	Impurity test derived from manufacturing processes (cell purity test, albumin residue test derived from fetal bovine serum), immunophenotype (target cells, non-target cells), transgene copy number
Impurities derived from the manufacturing process	Proliferative retrovirus, residual viral vector, bovine serum albumin
General Exams	Appearance, Properties, and Insoluble Foreign Matter Tests
Content test	Viral copy number test, number of transgenic cells, viability test
Characterization	Gene transfer copy number test, cell surface marker test
Biological activity or titer test	Cytotoxic activity, cytokine production, gene expression
Storage Stability Test	Long-term storage test, transport stability test, post-freeze-thaw (use) stability test

Inquiry flow

This is a general process from initial contact to actual works.