In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|December 17, 2014
Stelis Biopharma Builds Facility in Malaysia
Author(s)BioPharm International Editors
The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.
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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.
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