Will incorporate the latest single-use bioreactor systems for scale-up and process development
Stelis Biopharma, the Malaysian subsidiary of Indian pharmaceutical company Strides Arcolab, has broken ground for the construction of a US$60m biopharmaceutical facility at the Bio-Xcell Biotechnology Park in Nusajaya, Johor, Malaysia.
The company is building a 140,000ft2 (13,000m2) biologics facility on Malaysia's leading park and ecosystem for industrial healthcare biotechnology.
The state-of-the-art facility will incorporate the latest single-use bioreactor systems with both mammalian and microbial suites for manufacturing drug substances, in addition to high-speed filling lines with isolators for sterile finished products in all formats. The facility will also house an R&D unit to conduct scale-up and process development studies.
As well as manufacturing its own pipeline of biosimilars and biobetters for global markets, Stelis Biopharma also hopes to attract high-end contract and licensed manufacturing from leading companies.
At peak operations, the facility will employ 180 people in R&D, manufacturing, QA/QC, analytical and regulatory, of which a significant number will be local employees.
'Stelis is pleased to commence work on its flagship biopharmaceutical facility in Malaysia. With its strong commitment to bio-economy, attractive incentives, quality infrastructure and enabling ecosystem, we are confident of making this our bio-manufacturing hub for regional and global markets,' said Joe Thomas, CEO of Stelis Biopharma.
NNE Pharmaplan has been involved in the design of the facility and will manage construction under the guidance of Stelis Biopharma's project team. It is expected that the facility will take two years to complete, with commercial operations targeted to begin mid-2017.
The project complements the Stelis R&D facility in Bommasandra, where the company conducts pre-clinical R&D after which the development is transferred to Stelis Malaysia for scale-up to commercialisation.