Information
16-4 Dongbaekjungang-ro 16beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
+82 31-217-9959
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Overview
- Summary
- CellSafe Co., Ltd. is a bio-venture company established in 2009, specializing in providing a total solution for Mycoplasma detection, elimination, and prevention essential for cell culture. The company focuses on developing molecular diagnostic products and technologies for the safety evaluation and quality control of biopharmaceuticals. It holds a diverse portfolio of bio-safety analysis products, including PCR, RT-PCR, qPCR, and residual DNA analysis kits. CellSafe is dedicated to implementing optimal technologies for ensuring the safety and quality control of next-generation biopharmaceuticals.CellSafe Co., Ltd. is a bio-venture company established in 2009, specializing in providing a total solution for Mycoplasma detection, elimination, and prevention essential for cell culture. The company focuses on developing molecular diagnostic products and technologies for the safety evaluation and quality control of biopharmaceuticals. It holds a diverse portfolio of bio-safety analysis products, including PCR, RT-PCR, qPCR, and residual DNA analysis kits. CellSafe is dedicated to implementing optimal technologies for ensuring the safety and quality control of next-generation biopharmaceuticals.
- Key Products/Technologies
- Mycoplasma Total Solution: BioMycoX® Mycoplasma PCR Detection Kit (Cat. No. D-50, D-100), SafeDry™ Mycoplasma PCR Detection Kit (freeze-dried form, Cat. No. LD-8, LD-48), MycoQSearch qPCR detection kit, BioMycoX® Mycoplasma Elimination Kit, BioMycoX® Mycoplasma Prevention Spray, and other products for Mycoplasma detection, elimination, and prevention [23, 25, 26, 29, 33].Mycoplasma Total Solution: BioMycoX® Mycoplasma PCR Detection Kit (Cat. No. D-50, D-100), SafeDry™ Mycoplasma PCR Detection Kit (freeze-dried form, Cat. No. LD-8, LD-48), MycoQSearch qPCR detection kit, BioMycoX® Mycoplasma Elimination Kit, BioMycoX® Mycoplasma Prevention Spray, and other products for Mycoplasma detection, elimination, and prevention [23, 25, 26, 29, 33].
- Host Cell DNA (HCD) Analysis Products: ResidualQSearch CHO, HEK293, E. coli residual DNA analysis products launched [27, 29].Host Cell DNA (HCD) Analysis Products: ResidualQSearch CHO, HEK293, E. coli residual DNA analysis products launched [27, 29].
- Replication Competent Virus (RCV) Analysis Products: A range of detection products for various replication competent viruses, including Lentivirus, Adenovirus, and Retrovirus [4, 29].Replication Competent Virus (RCV) Analysis Products: A range of detection products for various replication competent viruses, including Lentivirus, Adenovirus, and Retrovirus [4, 29].
- Customized PCR/qPCR Premix and HCD/RCV Kit Development Services: Providing customized products tailored to specific customer purposes [4, 11, 29].Customized PCR/qPCR Premix and HCD/RCV Kit Development Services: Providing customized products tailored to specific customer purposes [4, 11, 29].
- Upcoming Products: 'Live or Dead?' next-generation Mycoplasma Detection Kit and a rapid sterility test method under development [12, 18].Upcoming Products: 'Live or Dead?' next-generation Mycoplasma Detection Kit and a rapid sterility test method under development [12, 18].
- Core Advantages
- Pioneering technological leadership as Asia's first developer of Mycoplasma qPCR detection and elimination kits [7, 23].Pioneering technological leadership as Asia's first developer of Mycoplasma qPCR detection and elimination kits [7, 23].
- Provision of a comprehensive Mycoplasma Total Solution covering detection, elimination, and prevention, ensuring overall cell culture safety for customers [15, 23, 29].Provision of a comprehensive Mycoplasma Total Solution covering detection, elimination, and prevention, ensuring overall cell culture safety for customers [15, 23, 29].
- Differentiated Mycoplasma elimination technology utilizing non-antibiotic, biological agents (BioMycoX®), effectively removing contaminants without cytotoxicity to mammalian cells [26, 30].Differentiated Mycoplasma elimination technology utilizing non-antibiotic, biological agents (BioMycoX®), effectively removing contaminants without cytotoxicity to mammalian cells [26, 30].
- Market dominance with over 60% of ATMP (Advanced Therapy Medicinal Product) companies in Korea trusting their NAT-based Mycoplasma testing methods [12, 18].Market dominance with over 60% of ATMP (Advanced Therapy Medicinal Product) companies in Korea trusting their NAT-based Mycoplasma testing methods [12, 18].
- Establishment of a systematic quality management system, including GMP-grade manufacturing and ISO13485 quality system adherence for all products [11, 35].Establishment of a systematic quality management system, including GMP-grade manufacturing and ISO13485 quality system adherence for all products [11, 35].
- High sensitivity (10-100 fg/reaction) and rapid (within 2-3 hours) Mycoplasma PCR detection technology, providing quick and accurate results [33].High sensitivity (10-100 fg/reaction) and rapid (within 2-3 hours) Mycoplasma PCR detection technology, providing quick and accurate results [33].
- Ability to flexibly respond to diverse customer research and production needs through customized PCR/qPCR premix and HCD/RCV kit development services [4, 11, 29].Ability to flexibly respond to diverse customer research and production needs through customized PCR/qPCR premix and HCD/RCV kit development services [4, 11, 29].
- Commitment to continuous technological innovation and R&D, contributing to the advancement of next-generation biopharmaceuticals and pursuing sustained growth [7, 11, 29, 35].Commitment to continuous technological innovation and R&D, contributing to the advancement of next-generation biopharmaceuticals and pursuing sustained growth [7, 11, 29, 35].
- Target Industrie
- Biopharmaceutical manufacturing and quality control industry [7, 11, 12, 18, 29].Biopharmaceutical manufacturing and quality control industry [7, 11, 12, 18, 29].
- Advanced Therapy Medicinal Product (ATMP) development and production industry [7, 12, 18].Advanced Therapy Medicinal Product (ATMP) development and production industry [7, 12, 18].
- Vaccine and biosimilar production industry [7, 11].Vaccine and biosimilar production industry [7, 11].
- Cell and gene therapy research and development industry [7, 27].Cell and gene therapy research and development industry [7, 27].
- Life science research and diagnostics fields [26, 30, 33].Life science research and diagnostics fields [26, 30, 33].
- Major Markets
- Japan (Primetech) [27], Singapore (Afirmus Biosource Pte Ltd., Spectrum incubation, Golden Equator branch establishment) [27], Taiwan (Tseng Hsiang Life Science Ltd.) [27]Japan (Primetech) [27], Singapore (Afirmus Biosource Pte Ltd., Spectrum incubation, Golden Equator branch establishment) [27], Taiwan (Tseng Hsiang Life Science Ltd.) [27]
- Germany (PELOBIOTECH GmbH) [27], Europe (CE certification acquired) [27]Germany (PELOBIOTECH GmbH) [27], Europe (CE certification acquired) [27]
- USA (Mycoplasma products entered the market, patent registrations) [27]USA (Mycoplasma products entered the market, patent registrations) [27]
- Certifications/Patents
- ISO13485 Quality Management System Certification (acquired 2019) [11, 27, 35].ISO13485 Quality Management System Certification (acquired 2019) [11, 27, 35].
- CE Certification (Europe, acquired 2020) [27].CE Certification (Europe, acquired 2020) [27].
- Operation of GMP-grade manufacturing facility [11, 27, 35].Operation of GMP-grade manufacturing facility [11, 27, 35].
- South Korean Patent Registrations: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2010, 2013, 2016) [27].South Korean Patent Registrations: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2010, 2013, 2016) [27].
- Japanese Patent Registration: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2015) [27].Japanese Patent Registration: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2015) [27].
- U.S. Patent Registrations: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2 patents, 2014) [27].U.S. Patent Registrations: "Method for culturing mycoplasma contamination-free cells and method for removing mycoplasma contamination of cells" (2 patents, 2014) [27].
- MycoQSearch, ResidualQSearch, ViralQSearch brand trademark registrations in Japan, US, Europe (2024) [27].MycoQSearch, ResidualQSearch, ViralQSearch brand trademark registrations in Japan, US, Europe (2024) [27].
- Corporate R&D Center recognized by Korea Industrial Technology Association (KOITA, 2012) [27].Corporate R&D Center recognized by Korea Industrial Technology Association (KOITA, 2012) [27].
- In vitro diagnostic medical device manufacturer permit (2019) [27].In vitro diagnostic medical device manufacturer permit (2019) [27].
- COVID-19 RT-qLAMP PCR diagnostic kit export approval (2020) [27].COVID-19 RT-qLAMP PCR diagnostic kit export approval (2020) [27].
- Prime Minister's Commendation (2016) [27].Prime Minister's Commendation (2016) [27].
- Ministry of Trade, Industry and Energy Award (2024) [27].Ministry of Trade, Industry and Energy Award (2024) [27].
- GDWEB BRONZE PRIZE (2024) [36].GDWEB BRONZE PRIZE (2024) [36].
Introduction
Location
16-4 Dongbaekjungang-ro 16beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
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