Your Trusted Partner for Bringing Safe and Effective Gene & Cell Therapies to Market
We have 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
Articles
Testing Support for DNA, RNA and all 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
- 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
Additional Specialized Solutions
Comprehensive testing solutions to assure the safety, identity, strength/potency, purity and quality of cell and gene therapy products.
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 for 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
SGS’s long history and expertise in biopharmaceutical testing, wide geographical footprint and superior client service support combine to provide an outstanding partner for your Cell and Gene Therapy outsourcing needs.
SGS has an expansive global network of laboratories, including 5 GMP facilities in North America, offering a broad portfolio of CMC testing solutions and scientific expertise with the highest quality standards under global GMP compliance.
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 found within our key biopharmaceutical pillars of biosafety, characterization and QC & release.