PRECLINICAL AND CLINICAL TRIAL SERVICES FOR VACCINE, ANTIVIRAL AND DIAGNOSTIC DEVELOPMENT
Viroclinics Biosciences has matured to a stage that a QA department, a clinical service department, a preclinical service department, an assay development department and a clinical trial operation department all work in an ISO 15189 accredited quality management system, expanded with elements of GLP and GCP. Viroclinics routinely performs a range of pre-clinical and clinical diagnostic services, including but not limited to; high throughput serology-, virology- and molecular assays, phenotyping, and genotyping in both translational studies and phase I-IV clinical studies. Moreover, in order to achieve sponsor’s development goals most efficiently, the company offers the option of designing customized models and protocols. As a final point, Viroclinics has an annual budget and supports an active in-house research and development program. Both preclinical and clinical diagnostic departments are supported by the assay development department for designing customized solutions. Furthermore, in association with the Viroscience Lab at the Erasmus MC, Viroclinics participates in a virus discovery program and epidemiological surveillance programs.
The clinical diagnostic testing services support and accelerate the market entry of new drugs, vaccines and antivirals, and assist in pre- and post marketing surveillance programs. Services are customized to specific needs, enabling maximum flexibility from day-to-day analysis to high throughput bulk analysis.
Efficacy and safety assays target protective immunological responses, assess viral loads and monitor drug resistance. In association with the assay development department, clinical diagnostic services offer tailor-made solutions in consultation with the sponsor in order to complete the study as efficiently as possible.
Through state of the art BSL2 and BSL3 containment facilities and qualified biotechnical staff we are able to test immunogenicity and efficacy of vaccines, antivirals, antibodies and other products aimed at preventing or treating virus infections. In addition we have a broad range of validated molecular assays available ranging from simple PCR analysis to sensitive sequence analysis directly from the clinical sample.
All analyses are performed according to ISO 15189 accreditation.
Viroclinics Xellerate provides better logistics support for the pharmaceutical, biotechnology, and medical device industries and gives us the opportunity to monitor the quality from the moment the sample is taken to the final test results. All personnel who are involved in the clinical trial are trained and all processes, temperature monitoring and assays are performed according to the ISO 15189 accredited quality system.
Logistic activities include preparation of virology sampling kits, on-site sampling handling instruction, courier transport, sample tracking and tracing (e.g. guaranteeing temperature controlled supply chain and online-sample timelines) , and management of sample processing labs. Viroclinics Xellerate support a smooth logistical flow of samples from all over the globe, and works together with a network of 36 processing laboratories in USA, Turkey, Mexico , Panama, Costa Rica, Argentina, Brazil , Peru ,Japan, South Korea, Singapore , China, Poland, Australia, India, South-Africa , Israel, Russia , Ukraine, Serbia, Colombia, UK, Germany, Spain, Saudi Arabia and Moldova.
Viroclinics Xplore offers preclinical services including testing of efficacy, safety, PK and (immune) toxicology of drugs, antibodies, vaccines and antivirals targeting viral infectious diseases. The BSL-2 and BSL-3 facilities enable complicated experiments with highly pathogenic viruses. The qualified biotech staff and use of state of the art BSL2 and BSL3 animal facilities are key to a successful outcome of studies.
Apart from the classical endpoints, we are also able to perform (histo) pathology of viral disease progression. Viroclinics Xplore offers validated diagnostic assays to measure serological and cell mediated immune responses, validated assays to detect virus presence and measure virus load in different tissues and, if needed, custom made assays as requested by the customer. Furthermore, Viroclinics Xplore continue to develop relevant models to monitor therapeutic efficacy and development of antiviral resistance, e.g. in immunocompromised animal models and for H7N9 influenza infection and pathogenesis.
Assay innovation and the introduction of new tools keep analysis up to date with the increasingly demanding criteria for developing new therapeutic and prophylactic candidates up to market registration. Customized assay and protocol development is followed by standardization and validation procedures to allow for routine application in a clinical trial setting.
For example, our influenza virus culture assay is now equipped with multiple read outs to safeguard virus detection in clinical samples. Our genotyping of virus isolates has been optimized to such a level that high quality gene sequences are obtained directly on patient materials with low viral load. In addition, flowcytometry, ELISPOT and Biospot equipment are in place to assess cell-mediated immunity, antibody-dependent cell-mediated cytotoxicity, viral plaque counts, size and growth kinetics. Our high resolution viral plaque assays enables studies on inhibition of both single and multiple infection/replication cycles.
In more detail:
- Training of sufficient employees to ensure redundancy in case of illness or other absence. Functions are substitutable as defined in a formal substitution matrix.
- Protocols are validated prior to release, and subsequently monitored and maintained on a regular defined basis. Moreover, the quality is monitored based on trending positive controls, conducting proficiency tests and performance of internal in-process audits.
- Equipment is validated prior to release, and subsequently monitored and maintained on a regular defined basis. Additionally there are multiple instruments for all the needed equipment. In the unlikely event of a breakdown, or unforeseen delays in maintenance, alternative equipment is available for continuation of the protocol.
- Temperature-regulating equipment (fridges, freezers, incubators) are monitored with a 24/7 alarm system, which in turn is monitored by a chain of personnel, such that there is always redundancy.
Key reagents must satisfy predefined criteria to be formally released prior to use.
- The quality management system is based on a feedback system, ensuring continuous improvement.
Viroclinics-DDL Diagnostic Laboratory participates in global surveillance programs to monitor and characterize novel virus threats to human and animal health (EMPERIE; EU FP-7). Additional research programs focus on genomics, discovery of biomarkers, correlates of protection and viral reference strain development. A recent example of a newly discovered virus Viroclinics participated in is the MERS Coronavirus. Furthermore, our scientists were at forefront of the discovery of hMPV in 2001 and SARS in 2003.