Anti-infective and vaccine development requires a partner that understands your unique, complex needs. With more than 35 years experience in infectious disease and immunology assay development and clinical trial testing, our scientific experts:
- Provide unique insights
- Enable end-to-end solutions
- Liaise with our clinical CRO
to optimize your study designs, ensuring better outcomes and accelerating your regulatory approval.
Our solutions include assay development, immunogenicity testing, genomic solutions, efficacy monitoring, project management and data management to meet your development needs across the entire vaccine development life cycle. We provide you with the global footprint that supports northern and southern hemisphere studies and the expertise to implement the right assay solutions to ensure your vaccine and anti-infective is safe and effective.
We offer an extensive test menu for vaccine and anti-infective efficacy and immunogenicity. We can collaborate with you on developing and validating customized assays to meet your drug development goals.
Our experienced and trained global project managers have knowledge of vaccine and infectious disease studies to provide our customers with best-in-class quality systems across our global network. Combined with our supply chain and quality management systems, we ensure sample integrity for high-quality data delivery and better outcomes.
Our quality systems tied to quality indicators provide you with data integrity to ensure regulatory submission success. Our vaccine centers of excellence have the following accreditation:
- ISO 9001:2015 certified (San Juan Capistrano, CA)
- CAP and ISO 15189:2012 certified (Pretoria, South Africa)
All testing is performed to the level of GCLP. Dedicated BSL-3 containment suites are also available to accommodate infectious agents requiring that level of containment.
Supply chain management
Viral and bacterial pathogens are temperature and time dependent and our logistical experts have the knowledge to implement temperature control monitoring/cold chain management to ensure the integrity of your study samples.
Solutions is an active participant in setting global immunogenicity assay standards. Partnering with the WHO and other global organizations, we provide insights and expertise to ensure best-in-class-methods. We incorporate those standards to increase your probability of study success.
Our vaccine laboratory services are highlighted in a recent New England Journal of Medicine Article
, where Q2
Solutions played a major role in establishing efficacy for an Influenza vaccine licensure.