SK Pharmteco
SK pharmteco provides comprehensive gene therapy manufacturing solutions, including process development, CGMP manufacturing, regulatory support, analytical testing, cell banking, and viral vector manufacturing. Their mission is to deliver scalable, innovative solutions to accelerate the development and commercialization of life-changing therapies, ensuring safety, quality, and regulatory compliance. They emphasize a flexible, transparent, and client-first approach to support their partners' success in the gene therapy field.
Industries
Nr. of Employees
large (251-1000)
SK Pharmteco
1000 Main Street, City, State, ZIP
Products
Optimized lentiviral manufacturing platform (proprietary)
A validated, plug-and-play lentiviral vector manufacturing process engineered for adherent or suspension workflows to deliver high productivity and validated analytical methods for release.
Optimized AAV manufacturing platform (proprietary)
An AAV production platform optimized for high yield and consistent product quality using HEK293-based processes with options for suspension processing in single-use bioreactors or shake flasks.
Optimized lentiviral manufacturing platform (proprietary)
A validated, plug-and-play lentiviral vector manufacturing process engineered for adherent or suspension workflows to deliver high productivity and validated analytical methods for release.
Optimized AAV manufacturing platform (proprietary)
An AAV production platform optimized for high yield and consistent product quality using HEK293-based processes with options for suspension processing in single-use bioreactors or shake flasks.
Services
cGMP manufacturing of viral vector drug substance and drug product across clinical and commercial scales, including upstream, downstream, purification, and fill/finish.
Process development services from early R&D to tech transfer, including upstream/downstream optimization, process characterization, and scale-up support.
Release, in-process, and extended characterization testing for gene therapy products, including sequence analysis and vector-specific assays delivered via high-throughput workflows.
Manufacture, testing, storage, and inventory management for master and working cell banks and master and working viral banks in segregated GMP facilities.
Regulatory strategy and preparation of submission packages (IND, BLA, marketing authorization), CMC documentation, briefing documents, and meeting support with global health authorities.
Preclinical manufacturing services that supply drug substance and drug product for toxicology, biodistribution, and proof-of-concept studies, using processes aligned to CGMP to reduce comparability risk.
cGMP manufacturing of viral vector drug substance and drug product across clinical and commercial scales, including upstream, downstream, purification, and fill/finish.
Process development services from early R&D to tech transfer, including upstream/downstream optimization, process characterization, and scale-up support.
Release, in-process, and extended characterization testing for gene therapy products, including sequence analysis and vector-specific assays delivered via high-throughput workflows.
Manufacture, testing, storage, and inventory management for master and working cell banks and master and working viral banks in segregated GMP facilities.
Regulatory strategy and preparation of submission packages (IND, BLA, marketing authorization), CMC documentation, briefing documents, and meeting support with global health authorities.
Preclinical manufacturing services that supply drug substance and drug product for toxicology, biodistribution, and proof-of-concept studies, using processes aligned to CGMP to reduce comparability risk.
Expertise Areas
- Viral vector manufacturing (AAV, lentivirus, adenovirus)
- Gene therapy process development and scale-up
- CGMP cell and viral banking
- Analytical testing and characterization for gene therapies
Key Technologies
- Adeno-associated virus (AAV) production
- Lentiviral vector production
- Adherent and suspension cell culture
- Single-use bioreactors
News & Updates
Gene therapy event in Phoenix, AZ from Oct 6 to Oct 8, 2025.
Gene therapy event in Seville, Spain from Nov 3 to Nov 5, 2025.
Gene therapy event in Vienna, Austria from Nov 7 to Nov 10, 2025.
White paper on cell line development for gene therapy vectors.
Technical poster on platform strategies to speed gene therapy development.
Inspection Pass Rate at All Facilities
0% inspection pass rate at all facilities.
Gene therapy event in Phoenix, AZ from Oct 6 to Oct 8, 2025.
Gene therapy event in Seville, Spain from Nov 3 to Nov 5, 2025.
Gene therapy event in Vienna, Austria from Nov 7 to Nov 10, 2025.
White paper on cell line development for gene therapy vectors.
Technical poster on platform strategies to speed gene therapy development.
Inspection Pass Rate at All Facilities
0% inspection pass rate at all facilities.