Continuous Manufacturing of Viral Vaccines

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Person receiving a vaccine
Takeda is exploring a number of innovative biomanufacturing technologies because it wants to increase its ability to bring vaccines to as many people around the globe as possible [Jeffrey Hamilton/Credit Images]

One of the top global healthcare needs is innovation in the manufacture of vaccines to allow for improved and equitable patient access around the globe regardless of economic class, according to Rahul Singhvi, PhD, COO, Takeda Vaccines. His talk at the Bioprocess International Conference was on the “Application of Continuous Manufacturing for Viral Vaccines.”

“My big picture question is what are we able to do in manufacturing to increase our ability to bring vaccines to as many people as possible, and this is particularly pertinent to the kinds of vaccines that we are developing here at Takeda. This includes a vaccine for dengue virus which is highly prevalent in tropical countries,” he said.

About 50% of the world’s population lives under the threat of dengue, which is responsible for approximately 390 million infections globally per year, according to Takeda.

Earlier this year the company reported that the pivotal Phase III trial of its dengue vaccine candidate met the primary efficacy endpoint. This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue vaccine (TAK-003) was efficacious in preventing dengue fever caused by any of the four serotypes of the virus.

While review of the data set is ongoing, TAK-003 was well tolerated with no significant safety concerns to date, according to the company. The TIDES trial is continuing, and additional results are expected later this year, along with results from other Phase III studies.

“The affordability question is important and if we are going to make an impact then having innovation in manufacturing is one way we can address the cost,” said Singhvi, who noted that the company is also working on vaccines for Zika and Norovirus. “If we can bring the cost of building capacity for vaccines down along with the cost of goods this provides for more flexibility in pricing.”

Singhvi also discussed the impact of vaccines on government healthcare spending, particularly the return on investment. “For every dollar spent on vaccination the return that society gets is very high—$16. That’s even more that money spent on primary education,” he said.

Singhvi pointed out Takeda is looking into a number of different innovative biomanufacturing technologies, but in regard to the continuous mode “it shrinks the manufacturing footprint of a facility because unit operations can be reduced in size and the flow rates are smaller, which reduces the size of your equipment.”

He emphasized that Takeda’s approach is not 100% continuous but that the company is employing specific principles of the technology as “we want to be judicious. We are interested in applying those principles of continuous processing where the bang for the buck is highest.”

“Continuous processing improves the productivity of specific unit  operations, reducing the cost and price of drugs,” explains Peter Levison, executive director, business development, Pall Biotech. “This makes medicines more accessible, improving health and quality of life.”

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