COVID-19 illustrated the life-saving role monoclonal antibodies can play during a global health crisis. The surge in demand for mAbs also underlined the need to find ways of accelerating production, boosting capacity, and cutting manufacturing costs, says Mapp Biopharmaceuticals CEO, Kevin Whaley.
“Many global health indications are in large cost sensitive markets,” he tells GEN, explaining that new biomanufacturing systems which make mAb production cheaper and faster would increase patient access. Innovation in biomanufacturing technologies could have a significant impact on efforts to bring down the cost of goods (COGs), i.e., the cost of making–mAb-based therapeutics.”
At commercial-scale, although processes differ product-to-product, mAb manufacture has become standardized. Despite this, there is still room for improvement at every unit operation, according to Whaley.
“We need bioprocessing systems that allow for increased expression, coupled with breakthroughs in downstream technology–particularly large-scale purification platforms–to make production more efficient and thereby reduce costs” he says.
COGs and capacity
The comments are in keeping with the conclusions of a study looking at mAbs for infectious diseases that Whaley co-wrote with Mapp Pharmaceuticals’ president Larry Zeitlin in July. The authors took recent calls to expand access to therapeutic mAbs by the International AIDS Vaccine Initiative (IAVI) and the Wellcome Trust as a starting point and discussed how industry could respond to try and meet this goal.
And according to Whaley and Zeitlin, high production costs and limited manufacturing capacity have the biggest impact on patient access.
“The most critical factor controlling wide accessibility is the cost of goods associated with mAb manufacturing. A consensus target for the COGS for mAbs to enable global access to these products is ~$10/g, far from the current COGS ranging from $95-200/g,” they say.
“The total mass of mAbs manufactured worldwide is estimated at 30 metric tons annually and as evidenced by the limited global access to mAb-based antivirals during the ongoing COVID-19 pandemic, will not be sufficient for rapidly addressing broad scale public health infectious disease threats.”
Developing the manufacturing systems that increase mAb output will require input from multiple parties, notes Whaley, who points out that “technology advances will need to involve both government and corporate funding. Collaboration between technology suppliers and drug companies [also] will be crucial.
Whether such collaboration will take place remains to be seen. However, as Whaley points out, for mAb developers the potential economic benefits of developing faster, lower cost production methods are significant.
“When an antibody is appropriate for a global health indication the potential market for the product is likely to be quite large.”