Our Commitment to Life Sciences during COVID-19.
SGS continues to closely follow the COVID-19 situation as it develops around the world. It is clear COVID-19 is developing at different rates in different countries. As a global organization, we are proactively working to ensure that the correct measures are in place for each territory to ensure all potential health and business risks are minimized.
For Life Sciences, our global network is being utilized to ensure continuity of service while reducing the impact of COVID-19.
We are committed to supporting our customers and their businesses at this time.
We offer extensive experience in novel vaccines, offering analytical, bioanalytical and clinical trial solutions, along with process management capabilities. With our integrated network of laboratories, we provide a wide range of essential services to support the fight against COVID-19.
Our Global Biosafety Centre of Excellence is located in the United Kingdom. It provides testing support for the biosafety and characterization of raw materials, cell bank and virus seeds for vaccines, cell and gene therapies, monoclonal antibodies and other recombinant protein based biological medicines, including a vaccine testing solution for coronavirus. We offer:
- GMP-compliant vaccine testing solutions: biosafety testing services for new viral threats/pandemic, using rapid and advanced testing platforms, such as Next Generation Sequencing (NGS) technologies, and over 400 validated rapid PCR tests for contaminating viruses of concern in vaccine manufacturing processes
- Specialized biosafety testing technology development: for vaccine and bio-therapeutics for drug manufacturing companies from our cGMP/cGLP certified, MHRA and US FDA registered laboratory. Our team pioneered the development of PCR, DNA sequencing, electron microscopy, and cell culture assays for biologic medicines under GMP
- All our methods are validated to meet ICH Q2 guidelines and are fully adapted to meet the requirements of your biologics
We provide comprehensive clinical trial management services, shaped to meet your specific R&D challenges and give you access to the best therapeutic expertise:
- Over 35 years experience in infectious disease and vaccine therapeutic areas through the complete clinical development cycle.
- Global, full-service CRO, having managed and/or executed more than 520 infectious studies during the last decade, both in early and late phase
- Regulatory and consultancy support with short Turnaround Times (TAT) – approx. four days – to get regulatory approval for COVID-19 projects run in Belgium
- Our Clinical Pharmacology Unit (CPU) in Antwerp recruits healthy volunteers/patients into therapeutic and vaccine COVID-19 trials, and performs swabs and PCR testing.
- Our experienced Modeling and Simulation team supports predicting the expected results of prospective trials, while optimizing study design to increase the probability of a successful efficacy and safety outcome.
- Clinical operations, biometrics, drug safety and pharmacovigilance teams with hands-on experience in COVID trials
- Offering effective solutions in accordance with EMA/FDA/HA guidelines and recommendations regarding the management of clinical trials in the context of the COVID-19 pandemic
With over 30 years of experience, operating out of our GLP/GCP compliant laboratories, we offer the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays). We support large-scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). Our bioanalysis services include:
- Testing new molecules: PK bioanalysis and method transfer, development and validation
- Measure biomarkers/blood samples testing: we offer assay development and validation of innovative biomarkers, with the support of our clinical teams
SGS offers you a global network of laboratories in North America, Europe and Asia-Pacific. From appearance testing to complex cell-based functional assays, our QC analytical groups are divided into pillars of excellence to enable reliable, rapid turnaround times, with expert analytical oversight over each analytical category. Our quality control services include:
- Raw material testing
- Extractable and leachable studies: container testing for manufacturers
- Sterility testing: microbiology (e.g. disinfectant efficacy studies)
We provide established expertise and resources for all aspects of biopharmaceuticals characterization – from physico-chemical properties, to primary, secondary, and tertiary structures, as well as aggregation. Our team pioneered the development of mass spectrometry mapping of biotechnology products together with other mass spectrometry strategies and biophysical methodologies which have become worldwide standards. Our characterization services include:
- Antibody testing
- Batch release testing for large number of doses
In response to a call to action from the US White House, and a coalition of leading research groups, SGS DigiComply has launched a tool using Artificial Intelligence (AI). This processes thousands of articles and scientific papers to provide scientific insights for medical teams around the world. COVID-19 INTEL helps medical research teams to combat the pandemic by answering the most pertinent questions the community is striving to answer:
- Comprises over 44,000 document published by and for the research community
- Uses natural language processing and AI to overcome the barriers faced by the research community when keeping up with the large and growing volume of research
- Can help generate new insights into the virus and its behaviour such as:
- What is known about transmission, incubation, and environmental stability?
- What do we know about COVID-19 risk factors?
- What do we know about virus genetics, origin and evolution?
- How can we understand how geography affects virality?
Next Normal Solutions
The COVID-19 pandemic is unprecedented in the modern era, posing unforeseen challenges to business continuity. At SGS, we are working hard to meet those challenges and support international efforts to beat COVID-19.
Our experts are responding to the challenges our clients face with innovative solutions to help operations now, to ensure business continuity for the duration of the pandemic, and to support the recovery and evolution through each phase of the ‘next normal’.