SCIEX and the Bioprocessing Technology Institute (BTI), a research institute under Singapore's Agency for Science, Technology and Research (A*STAR) with expertise in bioprocess science and engineering, have announced a collaboration to advance research and development in the area of biologics in Singapore.
Biologics refer to a new class of therapeutics, including monoclonal antibodies and antibody drug conjugates, which are increasingly being used for the treatment and prevention of human diseases. Unlike conventional drugs that are chemically synthesized, biologics are produced using cell cultures and represent an increasing growth area due to its potential to treat a range of conditions with no treatments available presently. While biologics hold great therapeutic benefits, much effort and cost is needed to purify these drugs, to eliminate residual components of the host cell system used in manufacturing. These components, or host cell proteins, may elicit unpredictable immune responses in patients or compromise the stability of the product.
The collaboration aims to meet the needs of the biopharmaceutical industry in developing accurate and high-throughput methods for analysis of these contaminants, to help the industry validate therapeutic candidates and ensure the safety and efficacy of biologics according to established regulatory guidelines.
Under the collaboration agreement, SCIEX will provide BTI with their reliable, sensitive and intuitive instruments including theTripleTOF® 6600 system and a Nano LC system, along with SCIEX software, and support from a team of application experts to assist with the analysis of complex contaminant protein molecules related to the production and analysis of biologic drugs.
BTI will supply SCIEX with data and validation results of methods developed in the course of the collaboration, while comprehensively profiling the host cell proteins or contaminants using the collaboration instruments. BTI will closely work with SCIEX’s demo chemists, applications chemists, and other concerned parties in the application of the methods developed.
"As Singapore is a recognised biomedical and biomanufacturing hub in the Asia Pacific, it gives us pride and honour to form this collaboration with an institute such as BTI who is spearheading innovative research in a very exciting and fast growing field like Biologics. Ultimately, by sharing our expertise and highly qualified resources, our analytical tools and solutions, and collaborating with BTI researchers, new methods and analyses will be developed in the quest to find treatments to new diseases, that will effectively improve people's lives," said Jean-Paul Mangeolle, President of SCIEX.
Professor Lam Kong Peng, Executive Director of BTI, said, "We see an increasing demand for new and innovative protein drugs that target diseases and are safer for patients. BTI will continue to work with industry partners such as SCIEX, combining our expertise in the production and analysis of biologics with the use of industry-leading high performance mass spectrometry instruments, to advance research in this area. We intend for our research to result in outcomes that can improve human health, meet the needs of the biopharmaceutical industry and enhance Singapore’s reputation as a world-class destination for biopharmaceutical R&D and manufacturing."