Top 10 Best Cell And Gene Therapy Software of 2026

Freestar (freestarcgt.com) is a comprehensive, cloud-based platform tailored exclusively for cell and gene therapy (CGT) commercialization, offering end-to-end solutions from clinical development through commercial manufacturing and supply chain orchestration. It provides specialized modules for capacity planning, patient journey management, regulatory compliance, and real-time visibility across the CGT lifecycle. By leveraging CGT domain expertise and AI-driven analytics, Freestar enables companies to scale therapies efficiently while maintaining stringent quality and traceability standards.

Nisoftex is a cloud-based ERP and MES platform designed for manufacturing sectors, including life sciences and cell and gene therapy (CGT) production. It provides end-to-end management of CGT workflows, from raw material tracking and batch production to quality control and regulatory compliance like 21 CFR Part 11 and GMP. The software excels in real-time monitoring, electronic batch records, and supply chain visibility tailored to the complexities of personalized therapies.

Benchling is a cloud-based R&D platform tailored for biotech and pharma, providing integrated tools for molecular design, experiment tracking, collaboration, inventory management, and workflow automation. For Cell and Gene Therapy (CGT), it supports end-to-end workflows including plasmid and viral vector design, cell line development, CRISPR editing, and GMP-compliant manufacturing processes. Its unified ELN, LIMS, and registry capabilities streamline data from discovery to scale-up, ensuring traceability and compliance.

Veeva Vault is a cloud-based platform providing unified content management, quality management, clinical operations, and regulatory information management tailored for life sciences, with specialized capabilities for cell and gene therapy (CGT). It supports end-to-end processes including clinical trial management, supply chain traceability, patient-specific lot tracking, and compliance with stringent FDA/EMA regulations for personalized therapies. The platform enables seamless collaboration across development, manufacturing, and commercialization while maintaining chain of identity and custody.

Scispot is an AI-powered lab operating system designed to accelerate biotech R&D and manufacturing, with strong capabilities in cell and gene therapy workflows including ELN, LIMS, inventory management, and automation orchestration. It unifies data across experiments, processes, and compliance to reduce manual work and enable scalable operations. The platform leverages AI for predictive insights, experiment design, and real-time decision-making tailored to CGT challenges like batch variability and regulatory adherence.

MasterControl is a comprehensive enterprise quality management system (EQMS) designed for life sciences industries, including cell and gene therapy (CGT) manufacturing. It offers modules for document control, CAPA, training management, audits, complaints, and supplier management, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other regulations critical for CGT. The platform provides traceability, automated workflows, and analytics to support quality assurance in complex, patient-specific CGT processes.

LabWare LIMS is a robust, configurable laboratory information management system tailored for cell and gene therapy (CGT) operations, enabling end-to-end sample tracking, batch manufacturing, and genealogy management. It supports GMP compliance, electronic batch records, and integration with manufacturing execution systems to streamline CGT workflows from raw materials to release. With modules for quality control, stability, and instrument integration, it helps scale production while maintaining regulatory adherence.

ValGenesis is a digital validation platform tailored for life sciences, including cell and gene therapy (CGT) manufacturing, offering a paperless Validation Life Cycle Management System (VLMS). It enables electronic validation, risk assessments, change control, and compliance with FDA 21 CFR Part 11 and Annex 11 standards. The software streamlines documentation, approvals, and audits, reducing validation timelines for complex CGT processes like autologous therapies and viral vector production.

LabVantage is a comprehensive Laboratory Information Management System (LIMS) tailored for biotech and pharmaceutical labs, with specialized capabilities for cell and gene therapy (CGT) workflows. It enables end-to-end traceability from raw materials like viral vectors and cells to patient-specific therapies, supporting batch record management, inventory control, and automated quality assurance. The platform ensures compliance with FDA, EMA, and GMP standards critical for CGT manufacturing, while integrating with ELNs and manufacturing execution systems.

Dotmatics provides a unified scientific informatics platform tailored for cell and gene therapy (CGT) R&D, enabling seamless data management from vector design to manufacturing. It integrates tools like SnapGene for plasmid and viral vector design, ELN for experiment tracking, and AI-driven analytics for process optimization and compliance. The platform supports GxP workflows, multi-omics data harmonization, and collaboration across discovery, development, and CMC stages.