Eurofins BPT grows Cell & Gene Therapy US Footprint

Loretta Sukhu, PhD, Senior Director of Operations, Bioassay, Cell & Gene Therapy, Biologics Raw Materials, EBPT Columbia; Stacie Fichthorn, Senior Manager, Biosafety Cell & Gene Therapy & Viral Clearance, EBPT Lancaster

Eurofins BioPharma Product Testing (EBPT) US is a pioneer in the analytical testing of Cell and Gene Therapy. Our first projects for Cell and Gene Therapy started in 2010 at our Eurofins BPT Lancaster, Pa, location. Over the past decade, Eurofins BPT has formulated a comprehensive business strategy that meets the analytical industry needs of Raw Materials, Cell Banks, Plasmids, and Viral Vectors (Lenti, Retro, Adeno, Adenoassociated), Genetically Modified Cells, CAR-T drug products and iPSCs. Eurofins BPT has continued to nurture the growth of Cell and Gene Therapy through various investments. This includes a focus on innovative technologies, such as droplet digital PCR (ddPCR), Analytical Ultracentrifugation (AUC), and Transmission Electron Microscope (TEM) testing. Investments also include dedicated space at several locations across the US.

In May 2023, the Lancaster site opened a 4,000 square foot laboratory space and hired staff dedicated to serving these specialized medicines. The ATMP lab is designed to accommodate many of the tests required to release viral vectors and cell therapies for use in cell and gene therapy applications. The space includes cell-based assay capabilities and instrumentation for a variety of endpoint analysis including qPCR, ddPCR, flow cytometry, and ELISA.

Eurofins BPT Lancaster is excited to feature Replication Competent test methods for Adeno (RCA), Retro (RCR), Lenti (RCL) and Adeno-associated (rcAAV) vectors. These methods are cell-based assays coupled with a vector-specific endpoint, fully validated and offered in a platform approach. As the methods were developed, turnaround times were optimized to deliver high quality results with the fastest means possible, while adhering to the expectations set forth by the regulatory agencies. These methods are another step toward our goal of a full service offering to Cell and Gene Therapy partners.

This year has also seen expansion at our Columbia, Missouri, site. This additional site extends the Cell and Gene laboratory services across two US Eurofins BPT locations, ensuring we are ready to accept these highly technical and complex programs. Eurofins BPT Columbia has state-of-the-art BSL-2 compliant Cell and Gene Therapy laboratories dedicated to viral testing, potency assessment, PCR, high throughput multiplex electro-chemiluminescence, flow cytometry and AUC. In addition to end point and quantitative PCR offerings, ddPCR supplies the ultrasensitive and absolute nucleic acid quantifications needed by Cell and Gene Therapy applications. Flow cytometry services are available to support clients who need to multiplex up to 13 individual targets in a single sample. Ultracentrifugation and SEC-MALS services are also offered for characterizing viral particles and other complex macromolecules. This comprehensive array of product characterization evaluations for Cell and Gene Therapy, including molecular weight determination, protein sequencing, peptide mapping, disulfide linkages and other posttranslational modification analyses are available.

The Eurofins BPT Columbia and Eurofins BPT Lancaster teams offer complimentary services, which supply options and redundancy to manufacturers of specialized medicines. Both facilities have supported testing of raw materials, drug substances and drug products from early phases of development through post marketing commercial programs. Stay tuned for more exciting news about Eurofins BPT and Cell and Gene Therapy coming in 2024!