Lentiviral & Gammaretroviral Vector Production & Testing

End-to-end GMP viral vector manufacturing, with in-house quality control, scalable production across lentiviral and retroviral platforms, downstream‑purified material testing, and GMP‑grade plasmid sourcing. We support small‑batch and pilot runs for process qualification and early clinical needs, as well as large-scale GMP manufacturing. We offer rigorous in-process and release testing, full regulatory guidance, and multiple viral vector envelope options tailored to your needs — all under one roof to ensure speed, consistency, and compliance. 

 

Versatile Viral Vector Production & Design 


  • Flexible platform support for Lentiviral (LVV) and proprietary Gammaretroviral (gRV) systems 

  • Custom envelope selection, including VSV-G, RD114 and GALV, to optimize target cell specificity 

  • Strategic sourcing of both research-grade (RUO) and GMP-grade plasmids platforms 


Benefit:
High biological flexibility with tailored vector configurations at a fraction of major license costs.

High-Yield Clinical Manufacturing Platform 


  • Modular scale-up using multilayer cell stacks for consistent culture performance 

  • Utilization of adherent HEK293T cell lines for robust growth, and high viral titers 

  • Optimized transient transfection protocols for quick Phase I/II clinical batch turnaround 


Benefit:
A reliable, cost-effective manufacturing path that accelerates timelines to the clinic.

Integrated cGMP QC of Viral Vector Products 


  • In-house QC for viral safety: RCR cultivation 

  • Sterility testing (membrane filtration), Mycoplasma (PCR), Endotoxin (LAL/PCR) 

  • Identity and characterization: p24 ELISA particle number, stability (pH, osmolality) 

  • Quantitative purity profiling (ELISA, PCR): Residual nuclease, host-cell protein, BSA, residual DNA (E1A, SV40, kanamycin) 

  • Vector potency assessment: infectious titer (HEK293T with flow cytometry), absolute VCN (d/qPCR) 


Benefit:
Workflow‑integrated QC that streamlines both vector release and transduction.

Advanced Downstream Processing & Testing 


  • High-efficiency viral concentration (up to 100x) via gentle Tangential Flow Filtration (TFF) 

  • Optimized diafiltration into tailored buffers for increased stability  

  • Final sterilizing filtration and rigorous in-house QC testing of the final vectors  


Benefit:
Maximized recovery of high-purity, sterile vectors for optimal target cell engineering.

 

More Ways We Help

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

cGMP Manufacturing and Quality Control

Cell therapy and viral vector
expertise with robust in-house QC capabilities

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Lentiviral & Gammaretroviral Vector Production & Testing

Viral vectors development and manufacturing - scalable RUO & GMP grades

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Analytical
Development

Analytical development include
method development,
optimization, and validation

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Process Development & Tech Transfer

Scalable, optimized processes
with successful transfer from lab to GMP 

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Apheresis Collection
& Logistics

Seamless needle‑to‑needle coordination across 150+ EU/US legacy apheresis sites — from apheresis to patient delivery

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Storage
& Distribution

Proprietary global GxP logistics, controlled storage, and cold chain management 

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.

Quality & Regulatory Support & Qualified Person Services

QP batch release under EU GMP and global compliance support 

 

Extensive Global Heritage in Apheresis Management

SCTbio draws on a long-standing legacy of working with more than 150 qualified and trained cell-collection sites across Europe and the USA. We provide dedicated apheresis support, with rapid reactivation and site‑specific procedure alignment to secure high‑quality clinical starting material.