SKyvec™ Lenti for in vivo Applications

In vivo lentiviral vector manufacturing produces vectors administered directly to patients, requiring higher doses, tighter impurity control, and CGMP-ready processes across development and commercial supply.

In vivo applications require higher vector quantities, stricter impurity thresholds, and more advanced characterization, increasing demands on process control, scalability, and regulatory readiness.

SK pharmteco supports in vivo LVV programs from early development through CGMP manufacturing, with integrated process development, analytical testing, and manufacturing capabilities.

SK pharmteco scales in vivo LVV manufacturing using controlled upstream and downstream processes, including suspension platforms and optimized IEX purification, maintaining consistency from bench to 500 L and into CGMP production.

Optimized downstream processes at SK pharmteco can achieve ≥70% recovery with a high IEX Yield and recovery approach, improving efficiency and reducing cost per dose compared to traditional ion exchange methods.

SK pharmteco integrates purification strategies designed to reduce host cell proteins, residual DNA, and process-related impurities to meet the higher purity requirements for systemic delivery. 

Batch consistency is maintained through tightly controlled upstream processes and optimized downstream workflows, including rapid IEX-based purification designed to reduce variability.

Process development defines scalable and reproducible conditions, optimizing yield, purity, and infectivity before transitioning into CGMP manufacturing.

SK pharmteco provides integrated support across process development, analytical testing, and manufacturing, including CMC strategy and IND/CTA readiness aligned with current regulatory expectations.

SK pharmteco supports in vivo lentiviral vector manufacturing from early development through clinical stages and commercial supply with scalable, controlled processes.