Oslo, Norway, and Beijing, China, 2 November 2021 – The Coalition for Epidemic Preparedness Innovations (CEPI) and Q2 Solutions, a wholly owned subsidiary of IQVIA and a leading clinical trial laboratory services organisation, today announce that Q2 Solutions’ facility in Beijing, China, has joined CEPI’s centralised laboratory network. This network is the largest and only global group launched to harmonise the assessment of COVID-19 vaccines currently undergoing preclinical and clinical trials. Q2 Solutions (Beijing) Co., Ltd. becomes the eleventh laboratory to join the network, and the first in East Asia.
The sample testing facility will follow the other CEPI-supported laboratories, all using the same methodologies and key reagents—substances used to carry out a scientific test—to measure and compare the type of immune responses and magnitude that the COVID-19 vaccines under development generates over time.
This is in contrast to the typical vaccine evaluation process, where the immune response of a vaccine candidate is assessed using different tools and measurements at individual testing sites, allowing for inter-laboratory variability. Following a centralised approach standardises testing of COVID-19 vaccines to ensure uniformity in assessment and allows researchers and regulators to accurately identify the most promising candidates.
CEPI’s centralised laboratory network first opened to all COVID-19 vaccine developers—both CEPI-funded and non-CEPI-funded—free of charge (excludes shipping charges), in October, 2020, for the analysis of vaccine clinical trial samples, up to Phase III studies. The programme is part of CEPI’s US $3.5 billion plan, to mitigate the immediate threat of COVID-19, while also looking to advance countermeasures and networks to dramatically reduce or even eliminate future epidemics and pandemics.
Other laboratories, already part of the group, are located in Bangladesh, Canada, India, Italy, Mexico, the Netherlands, UK, and the US. Q2 Solutions Vaccine Testing Laboratory in the US joined the network last year.
To date, over 45 COVID-19 vaccine developers have now used the service, with more than 15,000 clinical trial samples submitted for testing. Data obtained from the tests performed by laboratories in the network, including Q2 Solutions’ Beijing facility, will inform COVID-19 vaccine developers as to whether their candidate could advance to later-stage clinical trials and could also guide regulatory decisions. Results will also be used by CEPI to inform and advance the CEPI COVID-19 vaccine portfolio by providing quick and accurate evaluation of its candidate vaccines.
Executive Director of Vaccine Research and Development, CEPI
Q2 Solutions Chief Executive Officer
Since July 2021, some laboratories within the network have started assessing and harmonising incoming data on the performance of multiple COVID-19 vaccines against identified variants of concern – Alpha, Beta, Gamma, and Delta.
CEPI has, to date, provided up to US $17.5 million in funding to support the running of the network, including costs of the expanded variant testing programme.
Apply to use the Centralised Labs Network
In order to monitor interest and adjust the testing capacity, we are requesting that all COVID-19 vaccine developers interested in using CEPI’s centralised laboratory network complete this short survey. For any COVID-19 vaccine developer ready to submit their samples to the network, please complete our Sample Analysis Request Form.
Further information on the Centralised Labs Network
The clinical sample testing laboratories part of this collaborative vaccine network are: icddr,b (formerly International Centre for Diarrhoeal Disease Research Bangladesh), the National Institute for Biological Standards and Control (NIBSC; UK), Nexelis (Canada), Public Health England (PHE; UK), Q2 Solutions Beijing Facility (China), Q2 Solutions Morrisville facility (USA), Translational Health Science and Technology Institute (THSTI, India), the Unidad de Investigación Preclínica (UNIPREC), and the Laboratorio de Análisis de Moléculas y Medicamentos Biotecnológicos (LAMMB) at the Universidad Nacional Autónoma de México (UNAM; Mexico), Viroclinics-DDL (The Netherlands) and VisMederi Srl (Italy).
CEPI-funded COVID-19 vaccine developers are encouraged but are not obliged to use the centralised lab network. Results produced by the centralised lab network will be sent back to the COVID-19 vaccine developer – neither CEPI nor the laboratory who assessed the preclinical or clinical samples will own the data.
By opening the sample testing network to other COVID-19 vaccine programmes, CEPI aims to ensure that all eligible developers—regardless of their size—can benefit from this analysis. Certain commitments may be required for eligibility, such as making timely publication of sample testing results and sharing data that will be produced on the immunogenicity of COVID-19 vaccine candidates to facilitate future regulatory decisions. The number of samples available for testing per developer may be limited depending on response.
Further details on the network, including information on how the laboratories use the same key reagents to test COVID-19 vaccine clinical trial samples can be found on the CEPI website.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at www.endpandemics.cepi.net.
About Q2 Solutions
Q2 Solutions is a leading global clinical trial laboratory services organization providing comprehensive testing, project management, supply chain, biospecimen and consent management solutions.
Leveraging our next generation technologies, we deliver agile and precise services designed to meet the diverse needs of our clients. We focus our innovative solutions and scientific expertise on ADME, bioanalytical, genomics, vaccines and central laboratory services, including flow cytometry, anatomic pathology, immunoassay, molecular and companion diagnostics, while providing meticulous regional and global clinical trial implementation support and high-quality data delivery.
At Q2 Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion to turn the hope of patients and caregivers around the world into the help they need.
To learn more, visit www.Q2LabSolutions.com
Email: [email protected]
Phone: +44 7387 055214