Within our Pharmaceutical Development & Manufacturing organization, we operate a focused Drug Substance Development practice dedicated to genetic delivery platforms. Our Gene Therapy Vector Development capabilities are specific to lentiviral (LV) vector development, delivering phase-appropriate, laboratory-centered solutions that advance robust, documentable, and manufacturable R&D processes.
Overview of Lentiviral (LV) Vector
LV vectors are engineered gene-delivery systems derived from lentiviruses within the Retroviridae family. LV vector development involves engineering replication-incompetent gene delivery systems derived from lentiviruses, most commonly HIV-1, to enable stable and long-term expression of therapeutic or research genes in both dividing and non-dividing cells. Modern LV vectors are designed with split genetic components, self-inactivating elements, and heterologous envelope proteins to enhance safety, flexibility, and cell targeting, while minimizing the risk of replication or recombination. Their ability to carry relatively large genetic payloads and integrate into the host genome has made them a central platform in functional genomics, ex vivo cell therapies such as CAR-T cells, and gene therapies for inherited disorders, with ongoing development focused on improving safety, specificity, and scalable manufacturing.
Our Services
We offer an integrated set of services for LV vector development. Programs typically combine design rationalization, upstream prototyping, selective purification, and analytics into a unified development plan.
LV Design & Constructability Assessment Service
We begin by aligning the transfer vector architecture with intended expression logic and manufacturability. This includes evaluation of self-inactivating (SIN) backbones, promoter/enhancer choice, polyadenylation and WPRE options, and strategies for mono- or poly-cistronic payloads. We assess sequence features impacting packaging efficiency, recombination risk, and stability.
Pseudotype Strategy & Targetability Service
Envelope selection is central to particle stability, tropism range, and process compatibility. We perform comparative screens of common pseudotypes under standardized upstream and purification prototypes, evaluate titer yield versus functional transduction performance, and weigh buffer and temperature requirements. The service concludes with a pseudotype recommendation linked to critical material attributes (e.g., integrity after hold steps) and an initial formulation hypothesis.
Upstream Prototyping & Producer System Development Service
We develop transient or stable producer-cell-based LV generation prototypes tailored for development-grade use. Scope includes transfection/culture parameter space exploration, media/feed evaluations, and hold-time assessments to mitigate vector decay. We define control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs), establishing a reproducible upstream protocol.
Purification & Enrichment Development Service
Purification is engineered for vector integrity, balance of purity and yield, and buffer compatibility with downstream use. We construct a modular sequence—clarification, optional nuclease treatment, membrane or chromatographic enrichment, and polish—selected according to envelope sensitivity.
Analytical Characterization & Potency Establishment Service
We assemble an orthogonal analytical panel spanning identity, purity, quantity, and performance. Typical methods include particle/dose quantification, capsid/envelope integrity measures, residual testing, and cell-based functional readouts. We develop qualified protocols with controls, system suitability criteria, and acceptance ranges appropriate for development use. Where beneficial, we propose bridging strategies between quantitative readouts (e.g., titer modalities) to maintain continuity across studies.
Biosafety & Replicative Competence Surveillance Service
We establish and execute a development-grade surveillance plan to monitor unwanted replication-competent lentivirus signals. The plan integrates assay selection, sampling points, and decision criteria across upstream and purified materials.
We deliver end-to-end LV vector development focused on constructability, reproducibility, and analytic rigor. Our laboratory-centered, phase-appropriate approach helps teams de-risk decisions early and progress confidently. Contact us to architect a fit-for-purpose LV development plan.
Our products and services are for research use only.
