Cell therapies represent one of the most complex and rapidly evolving areas of modern medicine. Developing cell-based products requires precise characterization, robust analytical support and a clear path through evolving regulatory expectations for advanced therapies. For biotech and pharmaceutical organizations, ensuring product quality, identity, potency and consistency at every stage is critical to safe and successful development.
We provide a broad range of testing services designed specifically for cell therapies, supporting product quality, safety, identity, potency and consistency throughout development and manufacturing. Our global laboratory expertise and experience in advanced therapeutics enable us to act as a trusted partner from early-stage research through to clinical development and commercial supply.
Apply advanced analytical and bioanalytical testing to support robust characterization of cell-based products.
Generate reliable data aligned to global regulatory requirements for advanced therapies.
Access bioanalytical services for preclinical and clinical studies, including biomarker analysis, immunogenicity testing and potency assays.
Develop and validate assays that are reproducible, scalable and compliant with GLP, GMP and GCP requirements.
Apply sterility, microbiology, stability and comparability testing across raw materials, drug substances and finished products.
Maintain analytical continuity and quality control from early research through GMP manufacturing.
Advanced testing to characterize cell-based products and support critical quality attribute assessment.
Tailored assay development and validation to meet the complexity of cell therapies and global regulatory standards.
Verification of microbial safety across raw materials, drug substances and finished products.
Studies designed to evaluate product behavior over time and across manufacturing changes.
Quality control testing for raw materials, drug substances and finished products under GMP conditions.
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 cell-based product testing. Our analytical, bioanalytical and quality control capabilities are designed for the complexity of cell therapies, 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 research through to commercial manufacturing.
We provide a broad range of testing services designed specifically for cell therapies, supporting product quality, safety, identity, potency and consistency throughout development and manufacturing.
Our capabilities include advanced analytical and bioanalytical testing, method development and validation, sterility and microbiology testing, stability and comparability studies, and GMP quality control testing for raw materials, drug substances and finished products.
We support cell therapy programs from early-stage research to clinical development and commercial manufacturing. Our analytical and bioanalytical services help characterize critical quality attributes, while our method development and validation services ensure that assays remain reproducible and scalable as your program progresses.
Sterility, microbiology, stability, comparability 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 programs, including biomarker analysis, immunogenicity testing and potency assays. These services help generate reliable data to support clinical studies and regulatory submissions for advanced therapies.
Yes. Our method development and validation services are tailored to the complexity of cell therapies and designed to meet global regulatory standards, including GLP, GMP and GCP requirements. This supports the generation of robust, compliant data for advanced therapy programs.
We provide GMP quality control testing for raw materials, drug substances and finished products. This is complemented by sterility and microbiology testing, stability studies and comparability assessments to support consistent product quality across manufacturing.
5 South Avenue, Clydebank Business Park,
G81 2LG,
Glasgow, Strathclyde, United Kingdom