Singapore is a trusted and competitive manufacturing site for many biomedical companies. To date, seven leading biopharmaceutical companies and 25 medical technology companies have set up their manufacturing operations in Singapore. Pharmaceutical manufacturing facilities that have commenced commercial operations have also received zero major observations from international regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
BUILDING AN INTEGRATED DRUG DEVELOPMENT NETWORK
Leading biopharmaceutical companies are co-located with A*STAR research institutes at Biopolis, and engage in regular public–private partnerships. In recent years, biopharmaceutical companies in Singapore have tapped on this integrated research network to accelerate drug discovery and development.
The Biomedical Manufacturing industry in Singapore constituted 4.4% of Singapore’s GDP in 2015 and is the 2nd highest contributor in terms of value-add among all of the manufacturing sectors.
Today, Singapore is a globally leading location for biopharmaceutical manufacturing and home to 30 biopharmaceutical plants, manufacturing chemical active pharmaceutical ingredients and biologics for global demand. The conducive business environment, excellence in scientific research, robust intellectual property protection and skilled talent base have are cornerstones of Singapore’s success in attracting Biopharmaceutical Manufacturing investments.
BMRC’s Research Institutes are actively involved in research, innovation and development of advanced manufacturing processes and technologies in the areas of biologics and cell-based therapies. The Biomanufacturing research programme aims to sustain the Biopharmaceutical Manufacturing industry and enhance productivity through these activities.
Our Biologics Bioprocessing R&D programme leverages on the expertise of our research institutes to develop innovative processes for cost-effective manufacturing solutions. Using state-of-the art technologies, the program encompasses developing methods to maximize titre yield for biologics production, efficient bio-separation methods and novel analytics technologies. We work closely with academia, hospitals and industries to collaborate and combine expertise to deliver high-value outcomes.
CELL THERAPY MANUFACTURING R&D PROGRAMME
Cell Therapy is an emerging industry with high growth potential. Our Cell Therapy Manufacturing R&D programme is designed to address the key challenges in the large-scale manufacturing of Cell Therapy products and equip the industry with manufacturing processes and solutions. One key focus area is the development of bioreactor processes to scale-up human stem cells 3 to 10 folds higher than conventional 2 D culture by using novel microcarriers developed in our research institutes using different bioimplantable/biodegradable materials and define surfaces and coating.
Biomanufacturing is an important and major contributor to Singapore’s economic output. By engaging in leading edge research in manufacturing processes and technologies, we seek to continue to support the growth of this sector.
COLLABORATIONS IN PHARMACEUTICALS & BIOLOGY
CHUGAI PHARMABODY RESEARCH (CPR)
Chugai will invest approximately S$200 million over the next five years to establish Chugai Pharmabody Research (CPR), Singapore’s first corporate laboratory in the area of antibody engineering.
NEW TRANSLATIONAL ONCOLOGY NETWORK
Bayer Healthcare, a German pharmaceutical company, partnered five research institutions in Singapore to set up this network to further enhance research and development collaborations targeted at the growing cancer burden in Asia.
This network will also enhance Bayer Healthcare’s R&D partnerships in Singapore through the joint development and evaluation of novel treatment options and joint activities such as workshops and lectures. These initiatives will help to establish connections to other leading oncology centres in the region.
CLINICAL TRIAL CERTIFICATE (CTC) APPLICATION FOR ASLAN003
ASLAN003, a novel oral small molecule, has the potential to be a safer and more effective therapy than current treatments for rheumatoid arthritis, a disease that affects around one per cent of the world’s population.
Following the approval of its CTC application by the Singapore Health Sciences Authority (HSA), ASLAN Pharmaceuticals has started Phase 1 of its trial to assess the safety profile, tolerability and pharmacokinetics of ASLAN003.
DRUGS DEVELOPED IN SINGAPORE
The establishment of the Experimental Therapeutics Centre (ETC) and the Drug Discovery & Development (D3) platform in 2006 and 2011, respectively, aimed to cement A*STAR and Singapore’s position as one of the leading centres for the discovery and development of therapeutics in Asia. The activities in ETC and D3 operate in a seamless value chain, advancing promising early discoveries towards proof-of-concept in man in an effort to generate economic and health outcomes to benefit Singapore at large.
The successful development of a Wnt-Porcupine inhibitor as a potential treatment for breast cancer, was the result of a six-year partnership between ETC/D3 and Duke-NUS. In May 2015, this molecule, code-named ETC-159, attained the prestige of being the first molecule discovered and developed in Singapore to enter first-in-man trials.
Singapore’s second publicly funded cancer drug, ETC-206, has moved into first-in-man trials in December 2016. ETC-206 is a home-grown, made-in-Singapore cancer drug against blood cancers. In comparison to traditional chemotherapy, ETC-206 has a more targeted approach in treating leukaemia and other forms of blood cancer. There are 34 healthy volunteers currently involved in its Phase 1 clinical trials.
BRINGING PRECISION MEDICINE INTO THE CLINIC
Precision Medicine (PM) is an emerging approach for disease treatment and management. The advent of PM is the direct result of lower genomic sequencing costs and rapid improvements in molecular and sequencing technologies. PM seeks to take into account the patient’s genetic make-up and lifestyle influences to provide more precise diagnosis and in turn prescribe more targeted treatment. PM is most frequently practiced in cancer treatment, but it can also be extended to other diseases, including diabetes, infectious and neurological diseases.
Established in 2013, POLARIS (Personalised OMIC Lattice for Advanced Research and Improving Stratification) is one of the first Precision Medicine programmes to be funded by A*STAR. POLARIS has enabled A*STAR to a network between multiple research and clinical centres to translate research findings into clinical applications. POLARIS launched the POLARISTMTGFBI (Transforming Growth Factor beta Induced) eye genetic test in 2014 and the test is being used in the Singapore National Eye Centre. In 2015, POLARIS launched the POLARIS XploraTMCancer panel, which is available for patient testing in the National Cancer Centre, Singapore on a research-use basis.
The Asian Network for Translational Research and Cardiovascular Trials (ATTRaCT) aims to deepen our understanding of cardiovascular disease progression in heart failure. It integrates top expertise in cardiovascular clinical and biomedical sciences across the nation, bringing together four A*STAR research institutes (SBIC, GIS, SIgN and IMCB), two national heart institutions (the National Heart Centre and National University Heart Centre) as well as two academic institutions (NUS and Duke-NUS Graduate Medical School).
A major thrust of ATTRaCT is to identify a variety of biomarkers for diagnosis, prognosis and monitoring, using both human cohorts and animal models. These include imaging biomarkers, genetic and epigenetic determinants as well as protein, peptide and immunologic biomarkers.
The Surveillanceand Pharmacogenomics Initiative for Adverse Drug Reactions (SAPhIRE) aims to bring together the pharmacovigilance expertise of the Health Sciences Authority (HSA), scientific expertise of BMRC RIs (TLGM and GIS) and clinical resources of hospitals (NUHS and NHCS) to improve drug safety in Singapore. This is done through leveraging electronic medical records to identify patterns and early indications of adverse drug reactions in Singapore, discovery and validation of pharmacogenomic biomarkers in Asian populations and the development of robust pharmacogenomic diagnostic tests.