ITRI is committed to driving the development of various industries with its outstanding technology and research abilities in hopes to create economic values and promote social well-being. In addition to playing a role of researcher and developer in the fields of medicine as well as medical devices, it has also established a complete structure of CRO (Contract Research Organizations) and CDMO (Contract Development & Manufacturing Organization) services. The one-stop biomedical services platform of ITRI provides assistance in a wide range of scopes, including research and development, model translation, GXP trial production, pre-clinical/clinical trial, and post-marketing consultation. This mechanism makes it possible for domestic manufacturers to lower their initial cost of investment, and accelerate their research and development.
The one-stop biomedical services platform of ITRI.
- Regulation Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
- Licencing: Bio-IT technology, precision diagnostics and innovative medical technology, regeneration medicine technology, precision healthcare and nutrition technology, and targeted drug and delivery technology.
- Prototyping: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
- Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, and clinical trial analysis and reports.
- Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical document preparation, business ecosystem linkage, and more.
What We Offer
Laboratory of Cosmetics Microbial Testing and Functional Evaluation
The laboratory provides professional services for cosmetics companies to evaluate cosmetic functions and develop functional skincare products.
Services
- Melanin content, Viscoelasticity, Transepidermal water loss, Moisture content of skin surface
Core Facility
- Courage+Khazaka electronic Cutometer® MPA580
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Antibody engineering, gene editing, RNA in vitro transcription, and bioinformatics services
Our aim is to facilitate the bioindustrials in Taiwan by bridging the pre-clinical gaps between academia and industry. We offer a complete R&D pipeline services in pre-clinical development of protein, nucleic acid, and cell therapeutics.
Services
- Protein drug engineering and process development
- Antibody and protein production
- Antibody efficacy verification
- Antibody humanization and affinity maturation services
- Antibody formulation optimization
- Optimization of antibody production process
- Development of high-producing and stable mammalian cell lines
- Analytical method development of protein drug
- Stability test of protein drug
- Collagen scaffold fusion platform
- Antibody screening using murine hybridoma fusion
- Antibody-drug conjugation
- Gene editing (gene expression, knock-out and knock-in) and cell engineering
- Nucleic acid (mRNA, saRNA) production and activity analysis
- In vitro cancer cell model and murine syngeneic tumor model for drug efficacy evaluation
- Liver cancer stem cell establishment and drug screening platform
- Autoimmune disease platform
- Customized biological information service
- Analytical method establishment of NGS and other Omics data
- Establishment of biomedical database
- Development of artificial intelligence (machine learning) predictive models
Core Facility
Celigo Imaging Cytometer, ultracentrifuge, flow cytometer, cell sorter, ClonePix automated cellular screening system, GloMax® Discover Microplate Reader for luminescence detection, SpectroMax Paraigm multi-model detection system, ÄKTA avant fast protein liquid chromatography, high-performance liquid chromatography, real-time PCR system, refrigeration equipment, cell culture incubator, differential scanning calorimetry.
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Medical Device GMP Manufacturer under QMS
ITRI's medical device GMP manufacturer under QMS establishes testing services and trial production lines to assist in the verification of new technologies and cross the last mile.
The QMS/GMP process accumulates complete design and development documents and experience, and has high-quality medical device trial production and manufacturing technology to complete the QMS/GMP environment hardware implementation. It establishes testing services and trial production lines to assist in the verification of new technologies and bridge the last mile. Additionally, it promotes small-scale trial production of innovative service products and assists in nurturing start-up companies.
- Medical electrical product
- IVD product and others
- iKNOBeads, iPMx, and SARS-CoV2 reagent products obtained TFDA QMS registration (April, 2023)
- iPMx products (iPMx analyzer and covid-19 reagent kit) obtained TFDA project manufacturing approval (July, 2020 & Oct, 2022)
- iPMx products (iPMx analyzer and covid-19 regaent kit) approved by PMDA (Japan) (Dec, 2021)
- Obtained a medical device GMP factory manufacturer license (September 27, 2019)
- Obtained the GMP factory registration certificate (September 26, 2019)
- GMP factory environmental protection approval letter (July 8, 2019)
- It has a quality system that has passed ISO13485 (April 2, 2019)
Services
- Counseling GMP quality system (including design, manufacturing, packaging and shipping)
- Counseling plant design and planning
- Commissioned design and trial production
- Consignment manufacturing of medical electrical device
- Small batch mass production of IVD detection reagents or immunotherapy reagents and commissioned manufacturing
Core Facility
- It is mainly divided into medical electrical assembly plant, reagent sub-assembly plant, warehouse, and quality control laboratory.
- Core facilities include isolator, biosafety console, liquid chromatography analyzer, flow cytometer, particle counting and particle size analyzer, spectrophotometer, automatic cell counter, precision balance, refrigeration equipment, oscilloscope, and power supply.
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Cell Manufacture Factory
The first GTP facility in Taiwan offering cell production services. We have successfully assisted many customers establishing their GTP facilities and quality management systems. We provide contract service of culture room rental, product manufacturing, and process development.
- TFDA announced the Good Tissue Practice (GTP) standard operation (December 13, 2002)
- Factory registration certificate (November 8, 2007)
- Three QC Inspection tests have also passed TAF ISO/IEC 17025 certification (April 7, 2011)
- Manufacturing Pharmaceutical License registration certificate (October 2, 2015)
Services
- GTP Service
We consult on the manufacturing process to optimize cell therapy products for clinical trials. In addition, we provide GTP training courses and offer rental services for dedicated culture rooms.
- QC Testing Service
ISO/IEC 17025, TAF-certified sterility testing, endotoxin testing and mycoplasma testing
- Cell Storage in Liquid Nitrogen
Provide temporary storage of cell products produced in the ITRI CMF
- Customized Service
Regulatory consultation, plant design consultation, quality control validation services, assistance in pilot testing, method evaluation and validation, and product manufacturing
Core Facility
- Self-balancing program incubator, automatic control of liquid nitrogen storage, program cooling instrument, automatic cell counting instrument with data preservation function, ultra-low temperature refrigerator, clean room air conditioning system linked with monitoring system, emergency generator, air-cooled ice water machine
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Quality Control Laboratory of Cell Manufacturing Facility
Quality Control Laboratory of Cell Manufacturing Facility provides services including raw materials, intermediates and final products. We also provide contract research services for cell product inspection.
- The lab starts from April 7, 2011 and has a number of QC tests passed TAF ISO/IEC 17025 certification.
Services
Quality Control Inspection Services
- ISO/IEC 17025 and TAF certification
- Sterility and bacteriostasis/fungistasis tests by direct or membrane filtration method
- Endotoxin Test and inhibition/enhancement test for endotoxin by gel clotting method
- Mycoplasma test by PCR Method
- Cell Surface Antigen Analysis
- Automated Sterility Test (Automated Blood Culture System) (Compliance with Pharmacopoeia 7021)
- Consultation on Related Testing Items
Core Facility
- Automated sterility testing, ABI Veriti PCR machine, three low temperature incubator, constant temperature water bath, The Pyros Kinetix® Flex
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Cell Medium Products QMS/GMP Plant
The cell medium products QMS/GMP plant of ITRI is the only medium that can produce clinical-grade cells in Taiwan (including the medium that are imported from abroad).
Adhering to the spirit of continuous innovation of the ITRI, and accumulating the long-term culture medium research and development experience and production of the R&D team, the ITRI culture medium product QMS/GMP plant is the first medium product plant to pass Taiwan's second-class medical material QMS/GMP certification. Our serum-free medium can be used to produce clinical grade cells for use in human cell therapy. This breakthrough provides essential key raw materials for Taiwan's biotechnology industry, addressing the long-standing reliance on imported culture media.
- The only serum-free culture media factory with a second-class medical material approval registration in Taiwan
- The only medium that can produce clinical-grade cells in Taiwan (including the medium that are imported from abroad)
Services
- Customized commissioned serum-free medium research and development and mass production process development.
- Customized commissioned serum-free medium production.
- Purification of serum-free mesenchymal stem cells and transfer of high-efficiency in vitro proliferation technology.
Core Facility
- Aseptic semi-automatic filling machine with Class 100
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Biomaterial Product QMS/GMP Plant
Technical added-value: Our plant has met TFDA QMS/GMP quality system requirement. We are able to assist our clients in pre-clinical trial design and experiment to speed up product marketing processing.
Industry support: We assist domestic manufacturers with pilot trial medical production design and development, helping to reduce costs and manage risks.
Talent training: We offer training in implantable medical device skills, including product development and manufacturing, to enhance the added value of the medical device industry.
- Establish ASTM F2255, F2256, F2258 Validation processes of tissue sealing manufacturing and evaluation
- Establish ISO13485:2016, TFDA QMS/GMP, EU CE93/42/EEC, US FDA QMS quality system
- Four manufacutring facilities and two material preparation rooms for proudct pilot production manufacturing and evalution
Services
QMS/GMP service
- Provide pilot trial production on type III implant medical devices
- Provide assistance on pre-clinical trial experiments for industry and medical institutes
- Provide assistance on product development of implantable medical device in compliance with ISO regulations to reduce cost and initial investment
- Focus on satisfying unmed medical needs and research
Customized service
- Regulation consultation, Factory plant design consultation, Quality validation service, QC evalution and validation, OEM
Core Facility
- Class 10,000 clean room, RABs system, Static Hydraulic Industrial Series (Instron)
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GMP Pilot Plant for Botanical Drug Products
The first pilot plant for botanical drugs with international ICH standards and official GMP certification among all of foundations in Taiwan.
The first one pilot plant for botanical drugs with international ICH standards and official GMP certification among all of foundations in Taiwan. The rapid and systematic service platform for pilot run and quality control. It can be used for the development and application of new drugs and health products, and establish a scientific and systematic technology platform, which can accelerate the process of clinical translation and commercialization.
Services
- Optimization, scale-up, and standardization of process
- Test article preparation for non-clinical and early phase clinical trial
- Identification for botanical resource ingredients and production of standards
- Analytical method development and validation
- Stability study of the production
- CMC documents construction
- Coaching for health food certification
- Coaching for GMP
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API PIC/S GMP Pilot Plant
API PIC/S GMP Pilot Plant.
The pilot plant is funded by MOEA and ITRI, which becomes a PIC/S GMP inspected and qualified by TFDA. Through ITRI’s expertise team, we can offer customized products for preclinical and clinical use. This can shorten the development schedule in chemical synthesis and pharmaceutical mass production as well as the development of pharmaceutical analytics. In addition, the package services related with regulation science and PIC/S GMP consultation are provided.
- API cGMP pilot plant was built and manufactured for API (1997)
- Equipments were validated and run for manufacuring (2001)
- PIC/S GMP from TFDA approval (2020)
- PIC/S GDP from TFDA approval (2023)
Services
- GXP One-Stop Service platform: drug synthesis development and pilot manufacturing, analytical method development service platform, and GXP consulting service
Core Facility
- 10-500 L jacketed reactor, Class B, C and D cleaning room, sterile manufacturing area, quality control lab and P2 lab
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Core facilities of ITRI's API PIC/S GMP Pilot Plant.
ITRI's API PIC/S GMP Pilot Plant shortens the development schedule in chemical synthesis and pharmaceutical mass production as well as the development of pharmaceutical analytics.
Aseptic Pharmaceutical Formulation Factory
ITRI aims to speed up product development and commercialization of complex formulation drug and bring benefits to the pharmaceutical industry.
Complex drug product attracts more attention in pharmaceutical industry ascribing the high entry barriers having few players. ITRI’s aseptic pharmaceutical formulation team has profound experiences in formulation design, analytic methods establishment, scale-up manufacturing process development and customized production line design for complex drug products. Our services aim to speed up product development and commercialization of complex formulation drug and bring benefits to the pharmaceutical industry.
Services
- Formulation development:
- To assist manufacturers in developing the best formula through the Design of Experiments (DOE)
- Scale-up manufacturing and analytical method development:
- Microspheres manufacturing
- Liposomes manufacturing
- Sterile liquid manufacturing
- Optimized lyophilization process development
Core Facility
- Manufacturing instrument:
- Microspheres manufacturing
- High pressure homogenizer
- In-line homogenizer
- Spray dryer
- Isolator
- Automatic filling machine
- Tabletop filling machine
- Freeze dryer
- Analytical instrument:
- Chromatography (LC-UV, VIS, ELSD, GC)
- Particle size analyzer (nano grade, micro grade)
- Spray particles analyzer
- Differential scanning calorimeter
- Viscometer
- Osmometers
- Dissolution machine (USP dissolution apparatus 1, 2, 4)
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Molecular Testing Laboratory
ITRI's molecular testing lab provides precision medical molecular testing LDTs service.
Assist in upgrading laboratory results (RUO) to LDTs services, provide precision medical molecular testing LDTs service, and accelerate the commercialization process and benefits.
- ISO17025 certification and TFDA-LDTs list registration-two test items of mycoplasma and EGFR
- A core laboratory for molecular testing that meets the needs of international regulations
Services
- Molecular reagent product quality control test
- Consulting molecular laboratory construction planning and quality system construction
Core Facility
- Sample Pre-Processing System:
Nucleic acid (DNA & RNA) extraction and purification of various clinical samples
- Real-Time Nucleic Acid Amplification Detection System:
Nucleic acid molecule amplification quantitative detection, mutation and gene expression analysis
- Digital Nucleic Acid Amplification and Detection System:
High-sensitivity digital nucleic acid molecule amplification and quantitative detection
- Micro Nanoparticle Analysis System:
Cell Exosomes Analysis
- Gene Sequencing Analysis System:
Gene sequencing, mutation and gene expression analysis
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Animal Laboratory for Biomedical Research
ITRI's animal laboratory for biomedical research provides preclinical trials and technical platforms for drug development.
The Animal Laboratory for Biomedical Research (ALBR) was established to support the development of the biotechnology industry in accordance with national policies and invest in research and development in the fields of biotechnology, pharmaceutical industry, and medical device for promoting the research and development level of domestic academia and related industries. It mainly supports the needs of the research for biomedicine and medical materials related programs within the ITRI, and provides high-quality breeding environments and related technologies for laboratory animals.
- AAALAC certification (Since 2011)
Services
- In addition to providing animal breeding services, it also provides preclinical trials and technical platforms for drug development, such as efficacy evaluation of various disease animal models, safety testing, pathological interpretation, and blood and serum biochemical testing.
Core Facility
- ALBR is divided into public areas, pathological and biochemical analysis laboratories and three animal experiment areas according to functions, including general animal experiment area, clean barrier area and ABSL-2 animal experiment area. The districts maintain environmental isolation from each other, and the access control is independent. It is also equipped with a non-invasive ln Vivo Imaging System (IVIS®) for experimental needs.
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Regulatory Affairs Services
ITRI's regulatory affairs services.
ITRI aims to assist the development of the medical device industry. Our experts are experienced in the medical device sector and specialized in regulatory strategies for companies to meet all the regulatory compliance requirements. We also offer consulting services with a holistic approach to lead your product go to market in less time while reducing risks and costs. Partnering with us will help you to get the registration certificate for your product. Our experience includes FDA 510(k) submission and pre-submission, TFDA registration, and CE marking preparation.
Services
According to specific product and regulatory requirements, we provide systematic and strategic services to lead your product go to market more quickly and successfully, including:
- Consulting of compliance requirements
- Regulatory analysis and marketing strategy
- Training courses in regulatory affairs: Product Registration & Quilaty management system
- Regulatory submission and dossier building, including general safety and performance requirements, risk management, clinical evaluation, software verification and validation, cybersecurity, and human factors/usability engineering.
- Post-Market Surveillance Planning
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