05 January 2023 | News
Thermo Fisher to provide biologic manufacturing expertise and scale-up capacity to manage the clinical supply of eblasakimab
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Singapore-based ASLAN Pharmaceuticals and Thermo Fisher Scientific have announced a partnership to manufacture a high concentration formulation of eblasakimab for Phase 3 clinical trials.
Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to deliver a differentiated efficacy and safety profile for the treatment of moderate-to-severe atopic dermatitis (AD).
ASLAN has developed a high concentration formulation of eblasakimab, allowing up to 400mg eblasakimab to be administered in a single subcutaneous injection and suitable for use with different devices. Thermo Fisher plans to commence manufacturing the new formulation in its commercial-scale Good Manufacturing Practices (GMP) certified manufacturing facilities in January 2023.
“Thermo Fisher has made deep investments in biologics development and offers 20 years of process development experience in over 240 biologics development programmes, as well as a global infrastructure to scale up biologics manufacturing and deliver production continuity,” said Kiran Asarpota, Chief Operating Officer, ASLAN Pharmaceuticals.
Leon Wyszkowski, Thermo Fisher’s President of Pharma Services Commercial Operations said, “Our technology, including the 5,000-L Single-Use Bioreactor (SUB), will be used to manufacture the new high concentration formulation of eblasakimab and will enable larger-scale, single-use capabilities for late-stage trials and commercialization of this potential treatment for AD patients.”