We offer unparalleled expertise and industry-leading solutions for every stage of the Cell & Gene Therapy development process, including testing and stability services to get your product to the clinic and to market.
Our services are designed to ensure the safety, efficacy and quality of C> products – from cell therapies and viral vectors to nucleic acid products. Our global team of specialists and cutting-edge facilities enable manufacturers to navigate the complexities of C> product development and market introduction.
Our cell and gene therapy solutions
We provide a wide range of analytical solutions to assist C> manufacturers:
- Identification/design of the therapeutic vector
C> product manufacturers must identify the appropriate therapeutic vector and precisely define specific structural characteristics.
- Ensuring product safety and stability
C> product manufacturers face a major challenge in making sure their products are completely free from any harmful contaminants.
- Confirming quality and product consistency including support for raw and ancillary material analytics
SGS can aid manufacturers in confirming quality and product consistency throughout all stages of development by providing a broad range of services.
- Analyzing key purity markers
C> products must be free from all process and product-related biological and chemical contamination. SGS provides innovative solutions to identify any harmful contaminants which can highlight areas where product purity needs to be improved.
- Verifying potency and therapeutic activity
C> products need to have the desired therapeutic effect. In vitro potency verification reveals the product’s therapeutic activity, demonstrating the impact that it will have when administered to a patient.
Why choose this service from SGS
- Expert guidance
Support for all phases of C> development, in compliance with FDA, EMA, ICH and WHO guidelines.
- CandGT Assurance
Assurance of product safety, quality, consistency, stability, identity and potency.
- Comprehensive testing solutions
For raw and ancillary materials, drug substances and drug products.
- Advanced analytical methods
Including analytical ultracentrifugation (AUC), nanoparticle tracking analysis (NTA), resistive pulse sensing (RPS), electron microscopy and mass spectrometry.
- In-depth testing
For DNA, RNA, ncRNA and all viral vector-based gene therapies.
- Specialized solutions
Such as cell bank characterization, sequencing and structural characterization.
Why SGS?
World-leading C> expertise
With an unrivaled commitment to enhancing patient health through quality and efficacy, we offer you tailored services, collaboration with industry experts and access to our state-of-the-art facilities. Our comprehensive services range from contract development and manufacturing to analytical development, testing, clinical research and more, making us your indispensable partner in C> development.
Ready to transform the future of healthcare with your C> products?
Contact us today to discuss how we can help you optimize C> product development and market access.
Av. De las Américas, Centro de Convenciones, empresarial 2 oficina 6,
090505,
Guayaquil, Ecuador