Over the past ten years, Indian-based firm Glenmark Pharmaceuticals has increased its focus away from generic small molecules to proprietary biologics and in 2014 opened a plant in La Chaux-de-Fonds, Switzerland to support clinical monoclonal and bispecific antibody production.
The site houses a single-use production line at a 250L scale, but according to head of GMP Manufacturing Pascal Torregrossa a second suite based on the same processes but at a 1,000L scale is being considered among several ways to adapt current production capacity.
“The [current] maximum capacity is eight batches a year at 250L. This is not efficient to accommodate all [our pipeline needs] so we need to add a second line, to increase the scale,” he told delegates at the Bioprocessing International (BPI) European Summit in Amsterdam last month.
A 1,000L scale line, like the 250L, would be completely single-use in the upstream and comprised of around 70% single-use equipment in the downstream, he continued, and would add capacity for six batches a year.
The Manufacturability Challenge
Glenmark’s research pipeline consists of “traditional” monoclonal antibodies (its most advanced being GBR 830 for atopic dermatitis) and bispecific mAbs made using the firm’s BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform based on a stable CHO cell line using standard processes.
The dose range for the bispecific antibodies falls on the ng/kg range and so the amount of such product needed per year across its pipeline is in the gram scale, expected to increase to ten to hundreds of grams for commercial production.
Traditional mAbs, however, require doses measured in mg/kg and thus Glemark needs kilograms of clinical product per year rising significantly at a commercial scale.
“With the [two line] setup we will be able to accommodate all the clinical needs for the conventional mAbs and the bispecifics,” Torregrossa said. “But if you think about more conventional mAbs, we would need to produce 10-100kg of per year.”
As such the firm is considering its future commercial options. “We need to think about 5,000L, 10,000L scale – or multiple 2,000L if we want to stick with single-use.”
CORRECTION: The original article said that the 1,000L line was installed and awaiting Swiss Medic approval. The 1000L line has not been installed, Glenmark has since told us, and such an expansion is one way it is considering scaling-up given its ability to handle a broad range of cell lines with different productivities. The site is also not licensed for commercial production.