SKyvec™ Lentivirus Manufacturing for Advanced Therapies
Accelerate your lentiviral vector program with scalable, regulatory-ready manufacturing designed for cell and gene therapy applications. From plasmid design through drug substance and drug product, flexible platform and custom solutions support efficient progression from early development to clinical supply, enable by global operations, 100% process transparency, and adaptability in starting materials. Experience spans emerging biotechs and established pharmaceutical companies, supporting programs from preclinical development through early- and late-phase clinical stages, including complex and rare disease applications. Proven expertise across both adherent and suspension formats enables confident progression from gene to clinic for both ex vivo and in vivo applications.
Driving vector functionality through construct and plasmid design
Lentiviral vector efficiency is highly dependent on early design decisions that influence transduction, stability, and safety. Critical quality attributes—including potency, identity, purity, and genome integrity—are addressed through optimized plasmid architecture, regulatory elements, and sequence verification.
This approach supports:
Improved transduction efficiency and infectious titer
Control of replication-competent lentivirus (RCL) risk
Stable expression and reproducible vector performance
Establishing these parameters early reduces downstream variability and strengthens process robustness across development stages.
Capabilities
Tailor to your program
Our flexible lentiviral vector platform and customized manufacturing solutions support efficient progression from preclinical development through early- and late-phase clinical stages and commercial supply, including complex and rare disease applications. Integrated analytical services, cell banking, and regulatory expertise are combined with robust vector performance and reproducible manufacturing processes to help maintain product quality, process consistency, and supply continuity throughout the product lifecycle. With full-lifecycle support from plasmid design through fill-finish, our teams provide the expertise and flexibility needed to advance diverse lentiviral vector programs with confidence from gene to clinic in as little as 8 months.
Flexible Manufacturing for Diverse Applications
Lentiviral vector production requires adaptability across formats and therapeutic use cases. Our manufacturing capabilities support both adherent and scalable suspension systems, allowing alignment with program scale, modality, and lifecycle stage.
Optimized workflows to improve impurity clearance without compromising process quality
Full-lifecycle support from plasmid design through fill-finish
Robust vector performance and reproducible production
Established strategies to minimize RCL risk
Support for both ex vivo and emerging in vivo applications
This flexibility enables programs to evolve without requiring fundamental process redesign.
Built on a Flexible LVV Platform
Our lentiviral vector platform combines proprietary plasmid technologies, optimized HEK293 cell lines, and NGS-enabled characterization to support robust vector performance, enhanced process understanding, and reliable supply continuity. Backed by experience across conventional VSV-G, engineered, retargeted, and alternative envelope systems, the platform supports both suspension and adherent manufacturing approaches, providing flexibility for a broad range of advanced therapy applications.
Optimizing COGS in LVV Manufacturing
Cost efficiency in lentiviral vector production is driven by improving recovery, reducing variability, and shortening overall processing timelines, with flexibility to adapt strategies based on vector design and development stage. At SK pharmteco, this is achieved through a combination of optimized platforms and program-specific approaches:
Optimized workflows delivering strong titers and >2-fold improvement in infectious unit recovery compared to conventional methods
Flexible manufacturing strategies, with both platform-based and fully customized solutions across adherent and scalable suspension systems
Reduced batch failure risk through enhanced process control and alignment with program-specific requirements
These factors contribute to more predictable manufacturing economics and improved supply reliability.
Together, these approaches enable more predictable manufacturing economics, improved facility utilization, and reliable supply across development and commercial stages.
Featured Resource
Turning a Critical Supply Challenge into Clinical Success
In cell and gene therapy, unexpected supply disruptions can derail clinical progress and lead to costly delays. That’s exactly what one biotech company faced when a critical lentivirus supply fell through, just before a major milestone. Read our case study to see how we stepped in and quickly adapted to the customer’s project needs.
Lentiviral vectors are increasingly being explored for direct in vivo delivery, introducing additional complexity in dosing, purity, and safety requirements.
Manufacturing strategies for in vivo LVV focus on:
Enhanced impurity clearance and product characterization
Process control to support higher dose requirements
Scalable production aligned with systemic delivery needs
Scaling lentivirus production often leads to reduced potency or inconsistent yields, delaying timelines and increasing costs. Our processes maintain high titers and reproducibility across both adherent and suspension formats, even at 200 L scale.
We support projects from early shake-flask production through 500 L bioreactors, enabling seamless scale-up from preclinical through CGMP commercial lentivirus manufacturing.
Yes. In addition to adherent formats, we provide scalable suspension-based lentivirus production platforms that deliver consistent titers and support late-stage and commercial supply.
Our validated RCL testing strategies safeguard product integrity and ensure regulatory compliance, addressing one of the most critical concerns in lentivirus CDMO manufacturing.
With our optimized workflows, lentiviral vector programs can move from tech transfer to CGMP lentivirus manufacturing efficiently, supporting accelerated timelines toward the clinic.
Yes. We support transient lentivirus transfection processes and, where appropriate, stable producer cell lines, optimizing yield, cost, and long-term scalability.
Our optimized upstream and downstream processes minimize variability and maintain high-quality lentiviral vectors across scales, ensuring reliable supply for clinical and commercial use.
We provide analytical development, potency assays, comparability data, and regulatory support to align with FDA and EMA expectations for IND and BLA submissions related to lentiviral vectors.
Yes. As a full-service lentivirus CDMO, we provide integrated solutions covering plasmid supply, vector production, purification, and fill/finish.
We support a wide range of applications including CAR-T, TCR-T, and ex vivo hematopoietic stem cell therapies, leveraging our expertise in lentiviral vectors to enable diverse programs.
With our optimized platform and experienced team, programs can progress from gene design to clinic-ready material in as little as 8 months, reducing risk while accelerating development.
Yes. In addition to our plug-and-play platform for standard programs, our experienced team supports fully customized processes for unique constructs, indications, or program-specific needs.
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