Contact

What are you looking for?

Some topics you might be interested in

SGS Annual ReportJob OpportunitiesUpcoming WebinarsSustainability Solutions

Gene Therapies

Advance your gene therapy programs with expert analytical, bioanalytical and quality control services from SGS – supporting the characterization, safety and consistency of viral vectors, plasmids and gene-based products. 

Speak to an expert
Download brochure

Gene therapies are reshaping the treatment of complex and previously untreatable diseases. Developing gene-based products – including viral vectors, plasmids and finished gene therapy products – requires precise characterization, robust analytical methods and a clear path through evolving regulatory expectations for advanced therapies. For pharma and biotech organizations, maintaining product quality, safety, purity and consistency at every stage is critical for safe and successful development.

We provide a broad range of services to support gene therapy development, including analytical testing, bioanalytical support and quality control solutions tailored to complex advanced therapies. Our global laboratory expertise and experience in advanced therapeutics enable us to act as a trusted partner from early-stage development through to clinical trials and commercialization. 

Advance your gene therapy programs with confidence

  • Characterize viral vectors and gene therapy products

    Apply specialized testing to support product quality, safety, purity and consistency throughout development.

  • Monitor critical quality attributes

    Identify and track critical quality attributes (CQAs) to meet regulatory expectations for gene-based therapeutics. 

  • Support preclinical and clinical programs

    Access bioanalytical services including pharmacokinetics (PK), biodistribution, immunogenicity and biomarker analysis.

  • Ensure method reliability

    Develop and validate analytical methods that are robust, reproducible and compliant with GLP, GMP and GCP requirements.

  • Verify product stability and potency

    Apply stability studies, comparability testing and potency assays across development and manufacturing.

  • Progress from development to commercialization

    Maintain analytical continuity and GMP quality control from early research through commercial supply.

Our gene therapy testing services

  • Analytical testing and characterization

    Specialized testing for viral vectors, plasmids and gene therapy products to support product quality and consistency.

  • Bioanalytical services for preclinical and clinical studies

    PK, biodistribution, immunogenicity and biomarker analysis to generate reliable data for regulatory submissions and clinical trials.

  • Method development and validation

    Tailored analytical method development and validation for advanced therapies, aligned to global regulatory standards.

  • Stability and comparability studies

    Studies designed to evaluate gene therapy products over time and across manufacturing changes.

  • Potency assays

    Assays to support the assessment of biological activity for gene therapy products.

  • GMP quality control testing

    Quality control testing for raw materials, drug substances and finished products under GMP conditions.

SGS Biosafety Testing Laboratory Glasgow

Why SGS?

As the world's leading testing, inspection and certification company, we bring in-depth experience in advanced therapeutics, supported by a global laboratory network and specialist expertise in gene therapy testing. Our analytical, bioanalytical and quality control capabilities are designed for the complexity of gene-based products, helping you address evolving regulatory expectations with confidence.

As a trusted partner across the pharmaceutical and biotech sectors, we combine technical precision with the scale, accreditation and independence required to support advanced therapy programs from early development through to commercial manufacturing.

FAQs

We provide a broad range of services to support gene therapy development, including analytical testing, bioanalytical support and quality control solutions tailored to complex advanced therapies.

Our capabilities include characterization and testing for viral vectors, plasmids and gene therapy products, supporting product quality, safety, purity and consistency. Additional services include method development and validation, stability and comparability studies, potency assays and GMP quality control testing for raw materials, drug substances and finished products.

We support gene therapy programs from early-stage development to clinical trials and commercialization. Our analytical and characterization services help monitor critical quality attributes, while our method development and validation services ensure analytical methods remain robust and compliant as programs progress.

Stability studies, comparability testing, potency assays and GMP quality control testing provide continued assurance of product quality and consistency through clinical and commercial stages.

Our bioanalytical services support both preclinical and clinical studies, including pharmacokinetic (PK), biodistribution, immunogenicity and biomarker analysis. These services help generate reliable data to support regulatory submissions and clinical trial programs for gene-based therapeutics.

Yes. Our method development and validation services are designed specifically for advanced therapies and aligned to global regulatory standards, including GLP, GMP and GCP requirements. This supports the generation of robust, compliant data for gene therapy programs.

We provide GMP quality control testing for raw materials, drug substances and finished products. This is complemented by stability studies, comparability testing and potency assays to support consistent product quality across development and manufacturing.

News & Insights

View all
View all

Contact Us

Send us a message
  • SGS - United Kingdom - Glasgow

5 South Avenue, Clydebank Business Park,

G81 2LG,

Glasgow, Strathclyde, United Kingdom