SK pharmteco provides end‑to‑end CDMO services for viral vector‑based gene therapies, covering process development, CGMP manufacturing, analytical testing, and regulatory support for AAV, lentiviral, and adenoviral platforms. Their single U.S. facility offers scalable production from bench‑scale bioreactors to 1,000 L capacity, with parallel manufacturing suites and digital dashboards that give clients real‑time visibility into quality and supply continuity.
Funding
Funding not disclosed
Founders
Product
Problem
Developing gene therapies that use viral vectors such as AAV, lentivirus, and adenovirus requires specialized process development, scalable manufacturing, and regulatory support, which are often unavailable to biotech companies lacking dedicated facilities and expertise.
Solution
SK pharmteco offers end‑to‑end contract development and manufacturing (CDMO) services for viral vector‑based therapeutics. The company provides optimized process development to accelerate timelines and reduce cost of goods, followed by CGMP‑compliant manufacturing that can scale from bench‑scale bioreactors to 1,000 L production capacity. Integrated cell line and viral banking, analytical testing, and regulatory consulting ensure consistent product quality and facilitate interactions with global health authorities. All activities are performed at a single U.S. site in King of Prussia, PA, featuring three independent production suites and aseptic fill‑finish lines, enabling parallel runs and rapid tech transfer. A flexible, milestone‑based partnership model and transparent digital dashboards give clients real‑time visibility into safety and quality metrics.
Target Audience
Primary customers are biotech and pharmaceutical companies developing viral vector‑based gene therapies that require process development, GMP manufacturing, and regulatory assistance from early‑stage through commercial launch.
Features
- Process development workflows that streamline tech transfer, control variability, and lower manufacturing costs for AAV, LVV, and AdV vectors
- CGMP manufacturing capability with bioreactor capacity from bench scale to 500 L and scalability to 1,000 L via multiplexing
- Three independent production suites and two aseptic fill‑finish lines for parallel manufacturing of drug substance and drug product
- In‑house cell line development and plasmid engineering to maintain control over critical starting materials
- Integrated analytical testing and cell/viral banking to ensure product consistency and supply continuity
- Regulatory support covering CMC strategy, submissions, and global health authority interactions
- Digital batch records and client dashboards providing full traceability and real‑time quality metrics