SGS supports the analytical demands across all phases of cell and gene therapy development in compliance with FDA, EMA, ICH, and WHO guidelines.

We offer complete testing solutions to assure the safety, identity, strength/potency, purity and quality of raw materials, drug substances, and drug products with a comprehensive scope of services including:

• Method development
• Phase appropriate method validation
• Method Transfer
• Routine testing
• Stability testing
• Release Testing

With one of the most comprehensive analytical support packages for the manufacture of cell and gene therapy products, SGS provides access to an exceptional testing portfolio and expertise within our key biopharmaceutical pillars of biosafety, characterization, QC/release and bioanalysis.

Testing Support for DNA, RNA and Viral Vector-Based Gene Therapies

• Testing of ancillary and raw materials, drug substances, drug products and cell lines
• Confirming product identification, quality, consistency, and stability
• Identification of product- and process-related impurities
• Verifying potency and therapeutic activity
• Ensuring product safety

Additional Specialized Solutions

• Cell Bank Characterization
• DNA, mRNA & RNAi Sequencing and Structural Characterization
• Clinical Research & Trials
• Bioanalytical Services
• Encapsulation efficiencies
• Lipo-Nano Particle and other vector Characterization
• Container closure Integrity
• Extractable & Leachable assessment

SGS has a proven track record of supporting clients in their race to market and providing value through:

• Specialized, scientific expertise to navigate intricate testing requirements
• Ample capacity across our network of labs in North America
• Regulatory knowledge & quality systems to support all testing needs and IND filings
• Constant and transparent communication
• Flexibility and agility to meet demanding timelines

Whether you need testing support through every stage of the drug development cycle or just when your in-house capabilities are limited, SGS serves as your trusted partner to assure the safety, identity, strength/potency, purity and quality of your cell or gene therapy product.