SK Pharmteco
Global contract development and manufacturing organization (CDMO) offering integrated cGMP manufacturing, process development, analytical testing, and regulatory support for small molecules, cell and gene therapies. Operates multi-site manufacturing and testing facilities across key markets and provides end-to-end services from early development through commercial lifecycle management.
Industries
N/A
Services
Cell therapy CDMO services
End-to-end process development, GMP manufacturing, cryopreservation, QC testing, and logistics for autologous and allogeneic cell therapy programs.
Viral vector and plasmid DNA manufacturing
Manufacture of plasmid DNA and viral vectors including AAV, adenovirus, and lentivirus across development and GMP scales.
Small-molecule API development and commercial manufacturing
Process development, scale-up, cGMP API manufacturing, high-potency API handling, and lifecycle management for clinical and commercial supply.
Analytical development and testing services
Method development, validation, reference standard management, release testing, stability programs, forced degradation studies, and specialized impurity testing.
Regulatory affairs and CMC submission support
Strategic regulatory guidance and preparation of IND, BLA, marketing authorization packages, PPQ documentation, and briefing materials; support for regulatory meeting preparation.
Technology transfer and process validation
Technology transfer services, process performance qualification (PPQ), method validation, and continued process verification to transition products between development and commercial manufacturing.
Cell therapy CDMO services
End-to-end process development, GMP manufacturing, cryopreservation, QC testing, and logistics for autologous and allogeneic cell therapy programs.
Viral vector and plasmid DNA manufacturing
Manufacture of plasmid DNA and viral vectors including AAV, adenovirus, and lentivirus across development and GMP scales.
Small-molecule API development and commercial manufacturing
Process development, scale-up, cGMP API manufacturing, high-potency API handling, and lifecycle management for clinical and commercial supply.
Analytical development and testing services
Method development, validation, reference standard management, release testing, stability programs, forced degradation studies, and specialized impurity testing.
Regulatory affairs and CMC submission support
Strategic regulatory guidance and preparation of IND, BLA, marketing authorization packages, PPQ documentation, and briefing materials; support for regulatory meeting preparation.
Technology transfer and process validation
Technology transfer services, process performance qualification (PPQ), method validation, and continued process verification to transition products between development and commercial manufacturing.
Expertise Areas
- Cell and gene therapy manufacturing
- Viral vector and plasmid DNA production
- Small-molecule API process development and commercial manufacturing
- Analytical development and release testing
Key Technologies
- AAV, adenovirus, and lentivirus manufacturing platforms
- Plasmid DNA production
- cGMP API manufacturing and high-potency containment
- Continuous flow / continuous processing