Vaccine Development
Eurofins Vaccine Development Services
With over 35 years of experience, Eurofins Vaccine Development Services comprehensive capabilities support vaccine development programs from pre-clinical to human pharmacology studies [phase I trials], therapeutics exploratory studies [phase II], clinical efficacy and safety studies [phase III] and post authorization surveillance [phase IV]. With large sample numbers distributed over many locations, a need for expert global logistics support to maintain specimen integrity, quick turnaround time of
results and the necessity for globally combinable data, Eurofins is your go-to partner to support your Vaccine Development programs.
Global Laboratory CRO to support multi center, multi country studies in over 85 countries worldwide
• 6 dedicated testing facilities in USA, Europe and Asia
• 3 wholly owned Kit Packing and Distribution facilities
• Access to the broader Eurofins BioPharma Services global network of 125+ laboratories
• Access to the Eurofins PBMC network
Regulatory compliance
• Non clinical and GLP regulatory frameworks
• Applicable Good Clinical Laboratory Practice (GCLP) standards
• 21 CFR Part 11 where applicable
• CAP/CLIA
World renowned Assay Development, Validation and Testing Capabilities
• Assay development, transfer, and fit-for-purpose validation
• Safety and Efficacy Testing
• Immunoassays including
º ELISA/EIA
º Luminex® Microbead arrays
º MSD® electrochemiluminescence
º ELISpot
º Flow Cytometry including 25 Color NovoCyte® QuanteonTM and BD FACSymphonyTM A5 (27 color)
º ImmunoCAP™
• Immunogenicity, ADA and NAb Testing
• Biomarkers
• Molecular Testing including
º qPCR, RT-PCR, ddPCR
º Sanger and NGS sequencing
Matrices
Blood, Serum, Plasma, Sputum, Oral Mucosa, Nasal Swab, Nasal Lavage, Pulmonary Lavage, Urine, Stool, Occlusive Dressings, Surface Lesions, Anogenital Area.
Eurofins Kits Packing and Distribution
• 3 wholly owned Kit Packing and Distribution facilities in USA, Europe and China.
• Over 25 years of experience providing sample collection kits for Clinical Trials, Commercial DNA Testing, Clinical Monitoring Programs and Post Marketing Surveillance, both inside and outside Eurofins.
• High quality GMP and FDA compliant specimen and transportation kits to be distributed worldwide, including Home Collection Kits.
Eurofins PBMC Network
• 35+ qualified and harmonized laboratory locations worldwide
• New locations being added steadily based on new study requirements
• Global service offering effective harvesting, processing, cryopreservation, and analysis of peripheral blood
mononuclear cell (PBMCs)
• We have supported 25+ different Sponsor defined processing protocols, including less than 24 hours TAT and less than 8 hours TAT requirements
• Specialized downstream testing services include Cell Based Assays, (Flow Cytometry, EliSpot), RNA/DNA isolation and sequencing analysis, Protein extraction and quantification, and Virology specimen stabilization.
