Stelis Biopharma Builds Facility in Malaysia
The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.
Stelis Biopharma began construction of its customized, multi-product biopharmaceutical manufacturing facility at Bio-Xcell Biotechnology Park in Nusajaya, Johor, Malaysia, the company announced in a Dec. 3, 2014 press release. Stelis Biopharma is a wholly owned subsidiary of Strides Arcolab.
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. The 140,000-ft2 facility will incorporate 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. At peak operations, the facility will employ 180 people.
Source: Strides Arcolab
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
