Cerba Research provides the solutions to challenges in laboratory testing for Cell & Gene Therapy

The fast-paced Cell & Gene Therapy landscape brings the potential for health improvements for patients waiting for appropriate personalized treatments. As such, Cell & Gene Therapy biotech and pharma communities face the challenge of bringing novel therapeutics to the market within tight deadlines. Meeting the demands of Cell & Gene Therapies across all stages of the drug development process requires a strategic partner capable of dealing with highly complex clinical trial challenges.

As a specialty laboratory solutions provider, Cerba Research is at the forefront of addressing the complexity in Cell and Gene Therapy clinical trials and offers a comprehensive suite of solutions.

Project management expertise with Cell & Gene Therapy specific experience

Cerba Research provides end-to-end project management from sample receipt to data reporting, emphasizing customized assay development and logistics. Our scalable solutions, from preclinical to phase IV, ensure consistency, supported by proactive risk and contingency management for Cell & Gene Therapy clinical trials.

Access to a scientific and specialist network

Cerba Research offers a comprehensive scientific network. We specialize in genomics, molecular biology, flow cytometry, immunology, histopathology, virology, and diagnostics. In addition, we provide logistics account management to streamline sample and kit distribution, ensuring efficient clinical trial operations.

Extensive assay offering and testing customization

Our extensive assay offering aligned to relevant regulatory guidance, such as In Vitro Diagnostic Regulation (IVDR), includes a wide range of research areas, such as oncology, virology, autoimmune diseases, neurodegenerative disorders, rare diseases and metabolic conditions.

Global specialty laboratory with central laboratory network

Cerba Research provides access to specialized testing for Cell & Gene Therapy trials, supported by global central laboratory services. Our in-house molecular biology, genetics, biomarkers, histopathology, and flow cytometry capabilities are available in North America, Europe, Asia-Pacific, and Africa. In addition, we offer a global network comprising:

• Pre-processing laboratories
• PBMC/ BMMC isolation network
• Research, and partner laboratories

Customized logistics solutions for sample and kit management

Cerba Research provides tailor-made logistics solutions for managing samples and kits in Cell & Gene Therapy trials. Our multiple service levels include standard and premium, while a 24/7 helpdesk offers continuous support for contingency planning and seamless sample handling. We have the agility to adapt to both regional and global regulations (IATA/ADR compliant).

Learn more about our logistics capabilities here.

AAV immunogenicity screening

Cerba Research has an established track-record in support of market authorized AAV therapies.

• Various assays and platforms are available, including ELISA, MSD platform, NAb, and more.
• In-house produced and quality controlled IVD and IVDR compliant sample and assay kits.
• Dedicated account management team for 24/7 logistics support and diagnostic services.
• Rapid turn-around times (average 1-5 days) from sample pick up to reporting.
• A network of satellite analytical labs for AAV screening in remote regions.

Learn more here and download our AAV case study, a multi-centre prospective and validation study.