Thermo Fisher Scientific, the world leader in serving science, is continuously working to expand global capacity and capabilities across its leading pharma services network to support customers in government, industry and academia as they accelerate development and production of COVID-19 vaccines, therapies and other treatments. The company is now supporting over 200 projects globally. The company is also supporting multiple vaccine programmes globally that are in or entering human clinical trials, providing critical capacity and expertise that has accelerated development and readiness by months. In addition to its work on COVID-19-related vaccines and therapies, the company continues to ensure that patients undergoing clinical trials continue to receive the critical medicines they need during this crisis. Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific recently spoke to BioSpectrum about the company’s initiatives to counter COVID-19, particularly in India.
Edited Excerpts-
How is Thermo Fisher Scientific expanding its diagnostic capacity to fight the global pandemic?
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Globally, we saw a significant increase in the spread of the virus and our customers were getting inundated. As reliable partners, our primary objective was to scale our offerings to enable them to better navigate through this pandemic. We have been actively involved in understanding the structure of the virus, developing new diagnostic tests, providing personal protective equipment, reagents, and other laboratory essential instruments, to providing tools for vaccine research and development, clinical trials and even manufacturing some of the therapeutics. TaqPath COVID-19 Combo Kits were one of the first tests to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and are being extensively used across the world. Thermo Fisher now distributes its diagnostic test to more than 50 countries, including India, and has the capacity to produce more than 10 million COVID-19 tests per week globally to meet the rising demand. In the context of a serological test, our collaboration with Mayo Clinic and WuXi Diagnostics will significantly complement our PCR-based diagnostic test and will be a vital tool in containing the spread of the virus. We are still developing the antibody test, and we will pursue Emergency Use Authorization (EUA) from the FDA, as well as authorization from regulatory bodies in other parts of the world. Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection. Overall, we have been working closely with our customers, researchers, and government bodies to help set up high throughput labs. Our service and support teams are working around the clock to ensure the users are trained on our workflow solutions and build capabilities to be able to rapidly respond to the pandemic.
What are the company's contributions to the COVID-19 vaccine space so far?
Thermo Fisher is now supporting more than 200 projects to accelerate development and production of COVID-19 vaccines, therapies, and other treatments globally. For instance, our single use technologies (SUTs) that include the bioreactors, the single-use bags, cell- culture media, cell-lines, and chromatographic purification media, that enable timely vaccine design, development, testing, and production. In addition, our instruments are also used for critical in-depth analytical characterization, quality assurance (QA), and quality control (QC). Overall, our bioprocessing and virology portfolios offer proven solutions that help in tackling challenges of rapid vaccine production, quality improvement and increasing operational productivity. We also provide end-to-end solutions that include data management and clinical trials support. Thus, most, if not all, vaccine development needs can be met through the array of products and solutions we offer.
.
What will be the long-term impact of the pandemic on the pharma supply chain? What steps is Thermo Fisher taking in this regard?
COVID-19 has spurred several supply chain improvements and a relentless focus to improve capabilities to serve customers. At Thermo Fisher we have fast-tracked our manufacturing capacities to ensure continuous availability of products with consistent quality. We are leveraging our large distribution infrastructure and network to enable faster deliveries to support our customers with products and services they rely on to address this public health crisis. At present, we are not experiencing any significant supply issues for most of our products, however, we continue to closely monitor any potential supply-chain hurdles and identify measure to mitigate delays.
What are the major plans in store for the company for the post-COVID era?
The COVID-19 pandemic has put a spotlight on the tremendous value we provide as a company and the significant contributions we make to society. We would look at post COVID operations from two perspectives. Foremost, operating the company and ensuring the safety of our colleagues while we continue to meet customer expectations for product supply. Secondly, how can we help to enable the come back to the new normal? For this we are taking a multi-pronged approach by offering solutions to establish infrastructure for surveillance. The second point is readiness to scale. This is possible with the flexibility of regulatory processes to quickly approve tests for ramp-up. And finally leveraging public-private partnerships to build infrastructure and capacity to develop new vaccines and identify novel therapeutic interventions that can enable the country to respond quickly to this pandemic.
How is Thermo Fisher responding to the current disruption of clinical trials across the globe?
Thermo Fisher has been strategically investing in capacity and capabilities to increase manufacturing and supply chain flexibility to deliver critical medicines to patients for treating cancer, genetic diseases, and other serious health conditions apart from COVID-19. In addition to its work on COVID-19-related vaccines and therapies, the company continues to ensure that patients undergoing clinical trials continue to receive the critical medicines they need. A "site to patient" programme, launched at the start of the pandemic, has ensured clinical trial patients have uninterrupted access to life-saving investigational drug shipments without having to visit a clinic, one of many efforts to maintain supply chain continuity during the pandemic.
--------------
Dr Manbeena Chawla
(manbeena.chawla@mmactiv.com)
