Cell Therapy
Regulatory & Standards

Singapore’s Cell Therapy Advanced Manufacturing Programme (STAMP)

2 January 2020

Cell and gene therapies are set to revolutionise the future of medicine, but one of the major hurdles is the production of good quality cells cost-effectively and at scale.

Singapore is working hard to provide some (of the many needed) solutions to this problem. Leveraging its strong biopharmaceutical manufacturing base, logistics connectivity and global reputation of trust, Singapore is well placed to be a global leader in progressing the manufacturing of advanced cellular therapies.

Research, innovation and enterprise are cornerstones of Singapore’s national strategy to develop a knowledge-based, innovation-driven economy and society. Building on the government’s Research, Innovation and Enterprise 2020 (RIE 2020) plan, Singapore announced in March 2019 that it would be investing S$80 million to develop core capabilities required for cell therapy manufacturing. These include strategic programmes that address the major gaps in advanced cellular therapies manufacturing; scale-up, automation, cell therapy product development and new technologies for the assessment of safety, efficacy and quality of cells to meet global regulatory and manufacturing standards.

This multi-disciplinary initiative brings together and strengthens Singapore’s ecosystem of advanced cell therapy manufacturing players – from academia and public-sector research performers such as the Agency for Science, Technology and Research (A*STAR), to hospitals and regulators – to support industry along the entire cell therapy manufacturing process value chain from pre-clinical research to proof of concept (POC) clinical trials and Good Manufacturing Practice (GMP) manufacturing scale-up. This end-to-end integrated platform enables companies at any stage of development to tap into the required capabilities and is one of the key advantages which set Singapore apart. In addition to the infrastructure, Singapore also possesses an array of interdisciplinary capabilities and expertise spanning immunotherapy, regenerative medicines and critical manufacturing analytics.

Singapore’s regulatory agencies also play integral roles in this initiative, so that companies who work in Singapore will be assured that capabilities developed here comply with regulatory and GMP requirements. Singapore’s regulatory agencies are committed to developing a strong pipeline of talent for the industry in the field of cell therapy manufacturing.

Some examples of the capabilities being developed to unblock bottlenecks in the research process and accelerate the commercialisation of cell therapy products include (but not limited to):

  • label-free critical quality attributes (CQA) for cell quality and potency assessments
  • sensitive and rapid detection of adventitious agents for safety and quality assessments
  • closed and automated bioreactor systems for cell expansion, with reduced cell expansion cycles and manpower requirements
  • media formulation and design for optimised cell development and expansion, with reduced need for costly reagents and additives
  • strong expertise in immuno-monitoring and GMP genetic modification of immune cells for immunotherapy
  • GMP scale manufacturing process desiastar_infographic_blog_1gn and development
  • novel and/or optimised models for pre-clinical validations highly co-related to therapeutic outcomes

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Singapore's Cell Therapy

You can find out more about Singapore’s agency for science, technology and research