Stelis Biopharma has now commenced the construction of its customized, multi-product, biopharmaceutical manufacturing facility at Bio-XCell Biotechnology Park in Nusajaya, Johor, which is Malaysia’s premier park and ecosystem for industrial and healthcare biotechnology.
The company which is a wholly-owned subsidiary of Strides Arcolab and Bio-XCell had earlier inked a build and lease agreement with Bio-XCell for the construction of the building and part of the equipment of Stelis Biopharma’s 140,000 sq. ft biologics facility, for a total project investment amount of RM201 million or US$ 60 million.
The construction and fit-out of the facility is expected to be completed in 24 months and commercial operations are targeted to begin mid-2017 at Bio-XCell Park. The 140,000 sq. foot facility will incorporate ‘next-gen’ single-use bio-processing technology with both mammalian and microbial manufacturing suites. When complete, it will be one of the few regulated market approvable facilities in the region with end-to-end capability including sterile fill-finish across all formats. The facility will also house an R&D unit to conduct scale-up and process development studies.
“We have commenced work on the 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, Stelis Biopharma,
“The partnership with Stelis to build an advanced multi-product Biologics facility from the start, is seen as a first in Bio-XCell Biotechnology Park and timely given the close working relationship over the years. We are happy to see the 2nd bio-pharma project to commence which is expected to be commissioned in 2017,” said Rizatuddin Ramli, CEO, Bio-XCell, Malaysia.
It will manufacture and commercialize its internal and partnered pipeline of bio-pharmaceuticals besides cater to the demand for high-quality contract manufacturing and clinical supplies. 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.
Bio-XCell’s park’s strategic location in the Iskandar region of Johor with its close proximity to Singapore and access to a network of world-class seaports and airports within a short distance will help tap into the unmet regional and global demand for cost-effective biologics.