
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.
We provide a wide range of analytical solutions to assist C> manufacturers:
C> product manufacturers must identify the appropriate therapeutic vector and precisely define specific structural characteristics.
C> product manufacturers face a major challenge in making sure their products are completely free from any harmful contaminants.
SGS can aid manufacturers in confirming quality and product consistency throughout all stages of development by providing a broad range of services.
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.
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.
Support for all phases of C> development, in compliance with FDA, EMA, ICH and WHO guidelines.
Assurance of product safety, quality, consistency, stability, identity and potency.
For raw and ancillary materials, drug substances and drug products.
Including analytical ultracentrifugation (AUC), nanoparticle tracking analysis (NTA), resistive pulse sensing (RPS), electron microscopy and mass spectrometry.
For DNA, RNA, ncRNA and all viral vector-based gene therapies.
Such as cell bank characterization, sequencing and structural characterization.
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.
Contact us today to discuss how we can help you optimize C> product development and market access.