With unrivaled expertise in immunology on both sides of the client/CRO relationship, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.
The Nexelis team will transfer the assays developed at the Vaccine Research Center and further optimize for target species, i.e. ferret, mouse, NHP. The intended goal will be to utilize the assays for pre-clinical research and have the assays serve as a template for subsequent qualified assays for human trials. ELISAs will be performed on the pre-Fusion Stabilized Spike protein and to the Receptor Binding Domain (RBD) of the S1 subunit of the SARS-CoV-2 antigen. The Nexelis Protein Sciences team will express, purify and characterize these antigens to ensure suitability for assay use and consistency between lots. The Nexelis Protein Sciences team will make these materials available as requested by the Foundation
for assay comparability and bridging purposes.
The Nexelis team will also transfer the pseudovirus neutralization assay (PNA) using a lentivirus backbone and luciferase reporting system, and additional constructs will be evaluated as needed. Through our strategic partnership with Public Health England, a panel of samples will be analyzed in both the PNA and wild-type neutralization assay to ensure the PNA’s use as a surrogate. The Nexelis Protein Sciences team will also produce and characterize the pseudovirus. The Nexelis team will also facilitate through subcontracting wild-type neutralization assays if required.
Antigen and pseudovirus production and characterization is a key service of the Nexelis Protein Sciences team and will facilitate our assay transfer and qualification timelines. Sufficient materials will be produced such that requests for material can be made to Nexelis for access to reagents for standardization across assays. The team can produce endotoxin free material for animal model R&D work as well if requested.