The market for protein-based biotherapeutics is large and growing rapidly. In 2017, nearly 100 antibodies entered the clinical stage, a majority of which were for oncology indications, and the FDA approved 59 novel drugs in 2018. In 2019, the commercial pipeline was robust, with over 570 antibody therapeutics at various clinical phases. Besides non-conjugated full-sized human or humanized IgG1 antibodies, more and more sophisticated constructs are being developed, including bi-, tri- and tetravalent bodies, Fab, nanobodies, diabodies, single chain variable fragment, antibody-drug conjugates, binding domain of CAR-T cells, and fusion proteins.
These innovative therapies require complex analysis with advanced instrumentation and experienced study design and conduct. Our team in Evreux, France is handling the increased demand for these services with expanding laboratories and expertise to match. Led by European College of Veterinary Pathologists (ECVP) diplomate pathologists, the team is skilled in the analysis of these protein-based therapies, specializing in the investigation of tissue target expression and the evaluation of cross-reactivity using sophisticated immunohistochemistry and in situ hybridization techniques.
Our labs now feature six Ventana automated tissue testing systems, supporting high study volumes with consistent throughput, low background staining, and robust assay monitoring and documentation in a highly constrained regulatory environment.
The site conducts a variety of studies to drive decisions through all phases of preclinical development, including:
- Exploratory studies, on frozen or formalin-fixed paraffin-embedded (FFPE), normal or pathological, human or animal tissues, including tissue microarrays.
- Cross-reactivity studies, including method development, optimization, qualification and GLP-compliant studies submitted to authorities, with special attention to tissue morphology.
- In situ hybridization studies, with RNAscope™ and BASEscope™ technologies, which is particularly relevant in the gene and cell therapy field.