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SKyvec™ AAV Manufacturing for Advanced Therapies

Advance your AAV program with a partner experienced in clinical-stage manufacturing and scalable vector production. From construct design through drug substance and drug product, our high-yield, regulatory-ready platform and custom solutions enable rapid progression from early research to clinical and commercial supply. With operations in North America and Europe, we provide accelerated timelines, full process transparency, and flexibility in starting materials tailored to your program. Our focus on speed ensures you can meet critical milestones without compromise, while maintaining the highest standards of quality and efficiency.

Build Quality in from the Start

Eliminating inefficient designs and early-stage risk

Product safety, efficacy, and manufacturability begin at the construct level. Our approach integrates critical quality attributes (CQAs)—including potency, identity, purity, and genome integrity—early in development through advanced plasmid design, sequence verification, and regulatory element optimization. 

This foundation enables: 

  • Enhanced vector packaging, yield, and potency  
  • Reduced product-related impurities and improved full capsid recovery  
  • Elimination of risks such as replication-competent recombination, antibiotic resistance markers, and unintended DNA packaging  

By addressing these variables upfront, programs avoid costly redesigns and delays while establishing a strong path to scalable manufacturing. 

Capabilities

Tailored to Your Program

Flexible development strategies support both platform-based and fully customized AAV programs. Whether working with established serotypes or novel constructs, solutions are adapted to diverse serotypes, transgenes, and next-generation vector programs to meet your needs.
Integrated analytical testing, cell banking, and regulatory support ensure continuity across the product lifecycle—from development through clinical and commercial manufacturing.

A Distinctive Approach to AAV Manufacturing

Our fully integrated AAV platform combines proprietary HEK293 cell lines, plasmid technologies, scalable suspension manufacturing, and advanced analytical capabilities to support programs from development through GMP production. With extensive expertise across natural, engineered, and shuffled capsids, including next-generation vector programs, our teams provide the process knowledge, characterization expertise, and comparability strategies needed to accelerate development while maintaining product quality and consistency at scale.

Scale with Confidence

Processes are designed for linear scalability from early development through commercial production, with process development performed at scales up to 500 L to closely align with CGMP production conditions. This approach enables a controlled and efficient transition into manufacturing, minimizing variability during tech transfer. Consistent performance is maintained across scales through a well-characterized manufacturing platform and rigorous process control strategy. Proven scalability through 500 L and 1,000 L bioreactors demonstrates no loss of titer during scale-up, delivering uniform performance and consistent output across manufacturing systems.
Robust cell growth and high viability are maintained thorughout the process, reducing risk and ensuring reliable progression from development to CGMP manufacturing.

Built for Technology Transfer and Long-Term Supply

Our proprietary AAV production technologies are supported by dedicated development, MSAT, and manufacturing teams that work together to facilitate efficient technology transfer and successful process scale-up. Through integrated expertise, aligned manufacturing strategies, and global operational support, we help maintain process consistency, product quality, and supply continuity from early development through commercial production.

AAV Manufacturing FAQs

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