KOLON Biotech
Kolon Biotech is a CDMO focused on cell- and gene-based advanced biopharmaceuticals and exosome therapies. The company provides end-to-end services including technology transfer, process development and scale-up, GMP manufacturing (clinical to commercial), aseptic filling, quality control/testing, regulatory support (IND to BLA), and cold-chain storage and logistics. It operates dedicated GMP manufacturing facilities and QC laboratories in Korea.
Industries
Nr. of Employees
medium (51-250)
KOLON Biotech
Products
Bio Plant
Manufacturing facility with full services and equipment for cell and gene therapy and exosome therapy products development and manufacturing.
Bio Plant 2
17,000m2 facilities including production suites, QC area, warehouse, cell suites, filling rooms, and process development room.
Cell and Gene Therapy CDMO
End-to-end contract development and manufacturing organization (CDMO) services specializing in advanced advanced biopharmaceuticals, covering technology transfer, process development, GMP manufacturing, quality control, regulatory support, and storage/transportation.
줄기세포 치료제
임상 단계의 줄기세포(MSC, iPSC 등) 치료제 CDMO 및 공정개발, GMP 제조, 보관 서비스.
Quality Testing Service
Extensive QC and characterization methods supporting process testing, stability, and comparability studies including safety, potency, identity, and physical characterization tests.
GMP Compliance Service
Quality system service meeting latest global GMP standards, ensuring all production processes adhere to international GMP regulations with cGMP requirements, MFDS certification, FDA Drug Establishment Registration, and compliance with PIC/S, WHO, and ICH guidelines.
Bio Plant
Manufacturing facility with full services and equipment for cell and gene therapy and exosome therapy products development and manufacturing.
Bio Plant 2
17,000m2 facilities including production suites, QC area, warehouse, cell suites, filling rooms, and process development room.
Cell and Gene Therapy CDMO
End-to-end contract development and manufacturing organization (CDMO) services specializing in advanced advanced biopharmaceuticals, covering technology transfer, process development, GMP manufacturing, quality control, regulatory support, and storage/transportation.
줄기세포 치료제
임상 단계의 줄기세포(MSC, iPSC 등) 치료제 CDMO 및 공정개발, GMP 제조, 보관 서비스.
Quality Testing Service
Extensive QC and characterization methods supporting process testing, stability, and comparability studies including safety, potency, identity, and physical characterization tests.
GMP Compliance Service
Quality system service meeting latest global GMP standards, ensuring all production processes adhere to international GMP regulations with cGMP requirements, MFDS certification, FDA Drug Establishment Registration, and compliance with PIC/S, WHO, and ICH guidelines.
Services
Manufacture of clinical and commercial cell-, gene- and exosome-based therapeutics in dedicated GMP suites with aseptic filling capability.
Development and optimization of scalable, robust manufacturing processes (scale-up/scale-out) and support for automation and closed processing.
Execution of technology transfer into GMP environment with provision of validation documentation and process implementation support.
QC testing and characterization to support release, stability and comparability including sterility, mycoplasma, endotoxin, potency, cell counting/viability and PCR assays.
Regulatory support across development phases including CTD/RMP preparation, official meeting preparation, IND/BLA submissions and post-submission maintenance.
Cold-chain storage, warehouse capacity for cell banking and product storage, and transportation services to maintain product quality during distribution.
Manufacture of clinical and commercial cell-, gene- and exosome-based therapeutics in dedicated GMP suites with aseptic filling capability.
Development and optimization of scalable, robust manufacturing processes (scale-up/scale-out) and support for automation and closed processing.
Execution of technology transfer into GMP environment with provision of validation documentation and process implementation support.
QC testing and characterization to support release, stability and comparability including sterility, mycoplasma, endotoxin, potency, cell counting/viability and PCR assays.
Regulatory support across development phases including CTD/RMP preparation, official meeting preparation, IND/BLA submissions and post-submission maintenance.
Cold-chain storage, warehouse capacity for cell banking and product storage, and transportation services to maintain product quality during distribution.
Expertise Areas
- Cell and gene therapy contract development and manufacturing
- Process development and scale-up for adherent cell therapies
- GMP clinical and commercial manufacturing
- Regulatory submission preparation and lifecycle support
Key Technologies
- Automated 2D adherent cell culture
- 3D adherent cell culture systems
- Multi-layer flask and stacked vessel systems
- Large-scale culture vessels with automation
News & Updates
Commencement of operations at Bio 1 plant enabling clinical sample production and early commercial supply.
Initiated commercial production of cell and gene therapy products.
Commissioning of second large-scale manufacturing plant to expand large-batch production capability.
Obtained authorizations for advanced biopharmaceutical manufacturing and received GMP suitability determinations for biologics (raw material and finished product) in 2024.
Commencement of operations at Bio 1 plant enabling clinical sample production and early commercial supply.
Initiated commercial production of cell and gene therapy products.
Commissioning of second large-scale manufacturing plant to expand large-batch production capability.
Obtained authorizations for advanced biopharmaceutical manufacturing and received GMP suitability determinations for biologics (raw material and finished product) in 2024.