Thermo Fisher to employ 5kL single-use bioreactor for Aslan’s eczema mAb

Aslan Pharmaceuticals has contracted Thermo Fisher to produce its atopic dermatitis candidate eblasakimab.

Aslan’s lead candidate eblasakimab is being developed to treat atopic dermatitis (AD), the most common form of eczema. The monoclonal antibody (mAb) targets the IL-13 receptor α1 subunit (IL-13Rα1), which prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13), the key drivers of inflammation, central to triggering symptoms of allergy in atopic dermatitis, such as redness and itching of the skin.

The agreement will see Thermo Fisher manufacture a high concentration formulation (200 mg/ml) of eblasakimab for Phase III clinical trials and – if successful – commercialization at doses of up to 400 mg, delivered via a single subcutaneous injection.

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“Establishing this partnership with Thermo Fisher, a global leader in biologics manufacturing, is an important strategic milestone as we continue to advance the development of eblasakimab towards global Phase III clinical trials,” said Kiran Asarpota, COO of Aslan.

“Thermo Fisher has made deep investments in biologics development and offers 20 years of process development experience in over 240 biologics development programs, as well as a global infrastructure to scale up biologics manufacturing and deliver production continuity.”

Leon Wyszkowski, Thermo Fisher’s president of Pharma Services Commercial Operations, added: “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.”

Beyond 2,000 L

Single-use bioreactors have traditionally been restricted in size due to pressure challenges from the increased weight of the liquid medium in larger volume bags, with 2,000 L being the upper limit. If biomanufacturers require larger volumes, they generally would run several systems in unison or opt for stainless-steel tanks.

Bioprocess vendor launched a 4,300 L bioreactor (with 3,500 L of working volume) in 2015, and a 7,500 L single-use bioreactor with a working volume up to 6,000 L in 2019, with Thermo Fisher following suit in 2021, rolling out 3,000 L and 5,000 L HyPerforma DynaDrive bioreactors (first showcased at Biotech Week Boston in September 2019) on the back of customer demand for larger single-use bags.

While Thermo Fisher will commence eblasakimab manufacturing this month, an Aslan spokesperson would not divulge where production would take place. Thermo Fisher’s recently expanded St Louis, Missouri site and a site in Hangzhou, China that opened its doors last month both have the capacity to offer single-use biologics production at a 5,000 L scale.