NEOMED-LABS Vaccine Clinical Development and Immunology Services
NEOMED-LABS is a contract research organisation (CRO) offering high-quality clinical immunology services to develop, qualify, and validate vaccines and immunotherapies.
The company supports pharmaceutical and biotechnology companies with clinical development programmes and Phase I to Phase IV clinical trials. It provides good clinical laboratory practice (GCLP) compliant immuno-monitoring services, including immunotools engineering and stability testing.
NEOMED-LABS conducts activities at its state-of-the-art biosafety level (BSL) 2 and BSL 3 facilities in Laval, Canada. This clinical immunology laboratory was formerly part of GSK Vaccines’ clinical testing team and is now spun-out as a fully independent CRO featuring cutting-edge technology and supported by an extensive network of key opinion leaders (KOL) and scientific advisors. BSL2 can store more than 500,000 samples at temperatures between -20°C and -80°C.
Virology, bacteriology, protein optimisation and immunochemistry technologies
NEOMED-LABS’ services cover protein sciences, immunochemistry, virology and bacteriology. Its offerings include:
- Protein sciences – Protein expression in mammalian, bacterial and viral systems; purification; characterisation to determine size in solution, stability, folding, affinity, purity and identity; reproducibility of assay standards; and immunotools production
- Immunochemistry – Validated assays such as enzyme-linked immunoassays (ELISA) and competitive ligand-binding assays; immunogenicity, immunoglobulins subclass determination, the impact of cellular contaminants
- Virology – Functional automated assays such as neutralisation assays (µNT), including plaque reduction neutralisation tests (PRNT); assessment of functional antibody induction (HAI); and viral and cell banking
- Bacteriology – Automated rabbit and human complement-based serum bactericidal assays, human complement sourcing, master and working seed banking. adaptability to many strains
NEOMED-LABS’ vaccine expertise includes cytomegalovirus (CMV); human papillomaviruses (HPV); human respiratory syncytial (RSV); influenza viruses; measles, mumps and rubella viruses; the varicella-zoster virus; and chikungunya.
The company’s bacteria expertise includes Bordetella pertussis, Clostridium difficile toxins A and B, Clostridium tetani, Corynebacterium diphtheriae, Haemophilus influenzae, Neisseria meningitidis, Streptococcus pneumonia and Shigella sonnei.
Assay development, qualification, validation and testing
NEOMED-LABS has expertise in the development, qualification, validation and testing of assays, including custom design, method adaption and technology transfer for immunological assays.
The company is also experienced in producing viral and bacterial functional assays for GCLP clinical testing of vaccines from early to late-stage clinical development.
Protein optimisation services
NEOMED-LABS’ protein optimisation services include different bacterial and eukaryotic expression systems for protein design, expression, optimisation, generation and selection of stable cell lines.
The company also characterises protein biophysical properties, including size in solution, folding, stability, affinity and sequence integrity.
As part of its wide range of immunotools, NEOMED-LABS uses highly specialised equipment to engineer, purify and characterise proteins, as well as perform stability testing. It also optimises antigens to improve immunoassay efficiency and reproducibility.
Quantification of biological samples using enzyme-linked immunoassays
NEOMED-LABS quantifies biological samples utilising mesoscale discovery (MSD), o-phthalaldehyde (OPA) and multiplex o-phthalaldehyde (MOPA) assays, ELISA, human and rabbit serum bacterial antibodies (SBA) and host cell protein (HCP) detection.
The company detects immune markers in serum, plasma or cell culture supernatants.
Immunochemistry, virology and bacteriology services
NEOMED-LABS offers personalised, fast-track method validation for vaccines and immunotherapies through its range of automated platforms. It specialises in infectious vaccines for viruses, bacteria and toxins.
The company utilises high-quality equipment and expert immunoassay services to support virology and bacteriology development to meet the demand for humoral, innate and cell-mediated immunity.
It also delivers protein optimisation services and project consultancy.
NEOMED-LABS provides high-throughput testing using liquid handlers, automated readers, rapid data analysis, biostats and interim and final reports.
The company’s facilities have the capacity to produce more than 150,000 results annually, ensuring efficient support for large clinical trials such as post-licensure.
Project consultants and management services
NEOMED-LABS closely collaborates with its partners to ensure optimal interactions and consistent project development. A project manager is assigned to each project to optimise communication, timelines, follow-ups and quality assurance.
NEOMED-LABS also supports clients with logistics, methods of collection, storage, shipping and sample preparation. Its high-quality storage service is supported by an effective, web-based laboratory information management system (LIMS), which monitors sample quality from delivery to final testing.
The company ensures data protection, efficiency and quality in sample management, tracking and associated data tasks.