CellVec
CellVec is a GMP-certified gene therapy Contract Development and Manufacturing Organisation (CDMO) specializing in custom viral vectors for pre-clinical and clinical applications. Their mission is to empower clients by designing and building vectors that facilitate the transformation of therapeutic ideas into clinical practice, focusing on innovation for patient benefit. They leverage a proprietary lentivirus-based platform to overcome technological bottlenecks in viral vector production, supporting the advancement of gene therapies from bench to bedside.
Industries
Nr. of Employees
small (1-50)
Products
Lentiviral Vector Platform
A platform utilizing lentivirus-based vectors for the production and development of gene transfer technologies, aimed at overcoming technological bottlenecks in viral vector production.
Process Development
Services include transgene vector construct design, viral vector process development, and technology transfer for pre-customized processes.
Manufacturing
Production of clinical grade retro and lentiviral vectors under GMP as Active Pharmaceutical Ingredients (API) for human gene therapy, including upstream and downstream processing and fill finish in cryobags or vials.
Regulatory and Quality Assurance
Provision of regulatory support and advice for cell and gene therapy applications, along with maintaining a GMP-certified pharmaceutical quality system.
Quality Control and Characterisation
In-house developed viral vector quantification assays and partnerships for comprehensive viral vector characterization, including bioburden, mycoplasma, endotoxin, and other residuals.
Project Management
Management of projects to ensure compliance with international specifications for viral vectors.
Lentiviral Vector Platform
A platform utilizing lentivirus-based vectors for the production and development of gene transfer technologies, aimed at overcoming technological bottlenecks in viral vector production.
Process Development
Services include transgene vector construct design, viral vector process development, and technology transfer for pre-customized processes.
Manufacturing
Production of clinical grade retro and lentiviral vectors under GMP as Active Pharmaceutical Ingredients (API) for human gene therapy, including upstream and downstream processing and fill finish in cryobags or vials.
Regulatory and Quality Assurance
Provision of regulatory support and advice for cell and gene therapy applications, along with maintaining a GMP-certified pharmaceutical quality system.
Quality Control and Characterisation
In-house developed viral vector quantification assays and partnerships for comprehensive viral vector characterization, including bioburden, mycoplasma, endotoxin, and other residuals.
Project Management
Management of projects to ensure compliance with international specifications for viral vectors.
Services
Design and optimisation of transgene constructs and manufacturing processes, including transfection ratio optimisation, media reformulation, critical process parameter identification and technology transfer for customised processes.
GMP manufacture of clinical-grade retroviral and lentiviral vectors including upstream processing, downstream purification and aseptic fill–finish into cryobags or vials using single-use closed systems.
Regulatory support and quality assurance services operating within a GMP-certified pharmaceutical quality system aligned to PIC/S and other major regulatory frameworks, including support for audits.
In-house viral vector quantification (flow cytometry) and qPCR-based genome-integrated vector copy number assays, plus coordinated external testing for bioburden, mycoplasma, endotoxin, adventitious agents and residual impurities.
End-to-end project management from client onboarding through product release and delivery, coordinating timelines and expectations across development and manufacturing activities.
Design and optimisation of transgene constructs and manufacturing processes, including transfection ratio optimisation, media reformulation, critical process parameter identification and technology transfer for customised processes.
GMP manufacture of clinical-grade retroviral and lentiviral vectors including upstream processing, downstream purification and aseptic fill–finish into cryobags or vials using single-use closed systems.
Regulatory support and quality assurance services operating within a GMP-certified pharmaceutical quality system aligned to PIC/S and other major regulatory frameworks, including support for audits.
In-house viral vector quantification (flow cytometry) and qPCR-based genome-integrated vector copy number assays, plus coordinated external testing for bioburden, mycoplasma, endotoxin, adventitious agents and residual impurities.
End-to-end project management from client onboarding through product release and delivery, coordinating timelines and expectations across development and manufacturing activities.
Expertise Areas
- Viral vector manufacturing (lentiviral and retroviral)
- GMP biologics manufacturing and quality systems
- Process development for viral vectors
- Cell bank and producer cell line development
Key Technologies
- Lentiviral vector design (self-inactivating)
- GMP-compatible plasmid expression systems
- HEK293T-derived master cell banks
- Single-use closed bioprocess systems