Overview
- Summary
- SLS Bio is a biotechnology company specializing in pharmaceutical quality control, new drug development support services, and in-vitro diagnostic kit development. It is Korea's sole provider of comprehensive quality control services covering pharmaceuticals, quasi-drugs, and veterinary drugs. The company develops in-vitro diagnostic devices based on its nano-bio convergence multiplex diagnostic technologies, NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platforms. Recently, the company has been expanding its business into the food and cosmetics testing markets. SLS Bio was relisted on the KOSDAQ market in October 2023.SLS Bio is a biotechnology company specializing in pharmaceutical quality control, new drug development support services, and in-vitro diagnostic kit development. It is Korea's sole provider of comprehensive quality control services covering pharmaceuticals, quasi-drugs, and veterinary drugs. The company develops in-vitro diagnostic devices based on its nano-bio convergence multiplex diagnostic technologies, NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platforms. Recently, the company has been expanding its business into the food and cosmetics testing markets. SLS Bio was relisted on the KOSDAQ market in October 2023.
- Key Products/Technologies
- Pharmaceutical Quality Control Services: Comprehensive quality control services including finished drug product quality inspection, stability testing, and customized testing. Provision of quality control services for a wide range of products, including chemical drugs, biopharmaceuticals (vaccines, antibody treatments), and veterinary drugs.Pharmaceutical Quality Control Services: Comprehensive quality control services including finished drug product quality inspection, stability testing, and customized testing. Provision of quality control services for a wide range of products, including chemical drugs, biopharmaceuticals (vaccines, antibody treatments), and veterinary drugs.
- New Drug Development Support Services (CRO): Specialized services covering the entire new drug development cycle, such as clinical trial sample analysis, candidate substance efficacy evaluation, clinical design, and consulting. Provision of total services for obtaining IND (Investigational New Drug) approval.New Drug Development Support Services (CRO): Specialized services covering the entire new drug development cycle, such as clinical trial sample analysis, candidate substance efficacy evaluation, clinical design, and consulting. Provision of total services for obtaining IND (Investigational New Drug) approval.
- In-vitro Diagnostic Kit Development: Development of diagnostic kits based on NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platform technologies. Development of various diagnostic products including Fragile X, STR kits, Allergy Rapid Kits, Bovine Pregnancy Rapid Kits, and COVID-19 antibody diagnostic kits.In-vitro Diagnostic Kit Development: Development of diagnostic kits based on NTMD (Nano-bio Technology Multiplex Diagnostics) and NALF (Nucleic Acid Lateral Flow) platform technologies. Development of various diagnostic products including Fragile X, STR kits, Allergy Rapid Kits, Bovine Pregnancy Rapid Kits, and COVID-19 antibody diagnostic kits.
- NTMD (Nano-bio Technology Multiplex Diagnostics) Platform: Multiplex simultaneous diagnostic technology utilizing various nanomaterials. Contribution to reducing testing costs and shortening testing time.NTMD (Nano-bio Technology Multiplex Diagnostics) Platform: Multiplex simultaneous diagnostic technology utilizing various nanomaterials. Contribution to reducing testing costs and shortening testing time.
- NALF (Nucleic Acid Lateral Flow) Platform: Nucleic acid-based rapid diagnostic technology. Utilized for providing quick and accurate diagnostic results.NALF (Nucleic Acid Lateral Flow) Platform: Nucleic acid-based rapid diagnostic technology. Utilized for providing quick and accurate diagnostic results.
- Food and Cosmetics Testing Services: New business areas including agricultural and marine product safety testing, functional food testing, and cosmetic skin toxicity testing. Services targeting both domestic import and international export markets.Food and Cosmetics Testing Services: New business areas including agricultural and marine product safety testing, functional food testing, and cosmetic skin toxicity testing. Services targeting both domestic import and international export markets.
- Core Advantages
- Capability to Provide Korea's Only Comprehensive Quality Control Services: The company is Korea's sole provider of comprehensive quality control services covering pharmaceuticals, quasi-drugs, and veterinary drugs. Possession of KFDA approval for over 300 test items and products.Capability to Provide Korea's Only Comprehensive Quality Control Services: The company is Korea's sole provider of comprehensive quality control services covering pharmaceuticals, quasi-drugs, and veterinary drugs. Possession of KFDA approval for over 300 test items and products.
- Proprietary Diagnostic Platform Technology: Possession of nano-bio convergence multiplex diagnostic platform technologies such as NTMD and NALF. Capabilities for reducing testing costs, shortening testing time, and enabling multiplex simultaneous diagnosis.Proprietary Diagnostic Platform Technology: Possession of nano-bio convergence multiplex diagnostic platform technologies such as NTMD and NALF. Capabilities for reducing testing costs, shortening testing time, and enabling multiplex simultaneous diagnosis.
- Partnerships and References with Global Pharmaceutical Companies: Experience in collaborations with global pharmaceutical firms, including quality control for Novo Nordisk's obesity drug 'Wegovy' and contracts for mRNA vaccine quality inspection with global big pharma. Partnerships with leading domestic and international pharmaceutical companies such as Pfizer, GSK, and Amgen.Partnerships and References with Global Pharmaceutical Companies: Experience in collaborations with global pharmaceutical firms, including quality control for Novo Nordisk's obesity drug 'Wegovy' and contracts for mRNA vaccine quality inspection with global big pharma. Partnerships with leading domestic and international pharmaceutical companies such as Pfizer, GSK, and Amgen.
- Securing Growth Drivers through Business Diversification: Expansion from its stable pharmaceutical quality control business into new drug development support, in-vitro diagnostic kit development, and recently into the food and cosmetics testing markets. Aim for becoming a comprehensive testing and inspection institution.Securing Growth Drivers through Business Diversification: Expansion from its stable pharmaceutical quality control business into new drug development support, in-vitro diagnostic kit development, and recently into the food and cosmetics testing markets. Aim for becoming a comprehensive testing and inspection institution.
- Specialized Technical Personnel and R&D Capabilities: Numerous R&D achievements and ongoing projects through expert researchers in medicine, medical science, and biochemistry. A virtuous cycle of stable revenue leading to R&D investment.Specialized Technical Personnel and R&D Capabilities: Numerous R&D achievements and ongoing projects through expert researchers in medicine, medical science, and biochemistry. A virtuous cycle of stable revenue leading to R&D investment.
- Designated Institution by MFDS and MAFRA: Designated as a pharmaceutical quality inspection institution and clinical trial sample analysis institution by the Ministry of Food and Drug Safety. Certified as suitable for agricultural and marine product safety inspection by the National Agricultural Products Quality Management Service.Designated Institution by MFDS and MAFRA: Designated as a pharmaceutical quality inspection institution and clinical trial sample analysis institution by the Ministry of Food and Drug Safety. Certified as suitable for agricultural and marine product safety inspection by the National Agricultural Products Quality Management Service.
- Target Industries
- Pharmaceutical Industry: Quality control and new drug development support for chemical drugs, biopharmaceuticals (vaccines, antibody treatments, biosimilars), and veterinary drugs.Pharmaceutical Industry: Quality control and new drug development support for chemical drugs, biopharmaceuticals (vaccines, antibody treatments, biosimilars), and veterinary drugs.
- Medical and Diagnostic Industry: Development and supply of in-vitro diagnostic kits for humans and animals. Diagnosis of allergies, pregnancy, and infectious diseases.Medical and Diagnostic Industry: Development and supply of in-vitro diagnostic kits for humans and animals. Diagnosis of allergies, pregnancy, and infectious diseases.
- Food Industry: Ensuring food safety through agricultural and marine product safety testing, functional food testing, etc.Food Industry: Ensuring food safety through agricultural and marine product safety testing, functional food testing, etc.
- Cosmetics Industry: Quality and safety testing for cosmetics, including cosmetic skin toxicity testing.Cosmetics Industry: Quality and safety testing for cosmetics, including cosmetic skin toxicity testing.
- Major Markets
- Japan (patent acquisition for bovine pregnancy diagnostic kit)Japan (patent acquisition for bovine pregnancy diagnostic kit)
- EU (pursuing product registration and approval)EU (pursuing product registration and approval)
- USA (pursuing product registration and approval)USA (pursuing product registration and approval)
- Australia (patent acquisition for bovine pregnancy diagnostic kit)Australia (patent acquisition for bovine pregnancy diagnostic kit)
- Certifications/Patents
- KOLAS (Korea Laboratory Accreditation) Certification (Korea Accreditation System)KOLAS (Korea Laboratory Accreditation) Certification (Korea Accreditation System)
- Medical Device Manufacturing License (Ministry of Food and Drug Safety)Medical Device Manufacturing License (Ministry of Food and Drug Safety)
- STD 6-type Product Approval (Ministry of Food and Drug Safety)STD 6-type Product Approval (Ministry of Food and Drug Safety)
- Japanese Patent Acquisition for Bovine Pregnancy Diagnostic KitJapanese Patent Acquisition for Bovine Pregnancy Diagnostic Kit
- Australian Patent Acquisition for Bovine Pregnancy Diagnostic KitAustralian Patent Acquisition for Bovine Pregnancy Diagnostic Kit
- Designated as a Pharmaceutical Quality Inspection Institution and Clinical Trial Sample Analysis Institution by the Ministry of Food and Drug SafetyDesignated as a Pharmaceutical Quality Inspection Institution and Clinical Trial Sample Analysis Institution by the Ministry of Food and Drug Safety
- Suitability Approval for Agricultural and Marine Product Safety Inspection Institution (National Agricultural Products Quality Management Service)Suitability Approval for Agricultural and Marine Product Safety Inspection Institution (National Agricultural Products Quality Management Service)
- Additional KFDA Approval for Advanced Biopharmaceutical 'Antibody Therapeutic' Quality Testing ItemsAdditional KFDA Approval for Advanced Biopharmaceutical 'Antibody Therapeutic' Quality Testing Items
- KFDA Approval for Nitrosamine Impurity Testing Items (carcinogenic substances)KFDA Approval for Nitrosamine Impurity Testing Items (carcinogenic substances)
Introduction
Location
7F, 260 Changnyong-daero, Yeongtong-gu, Suwon, Gyeonggi-do, South Korea
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