Cytiva, a global life sciences leader, is installing its first FlexFactory in the Middle East and North African region as part of SaudiVax’s planned Saudi Vaccine and Bioprocessing Center (SVBC), a Saudi government-funded project led by King Abdulaziz City for Science and Technology and the National Industrial Development Center.
The SVBC will use Cytiva’s FlexFactory to manufacture halal vaccines and biologics in-region, for-region, as part of an effort to heighten protection against the spread of communicable diseases among Saudi residents and visitors to the region.
Professor Mazen M. Hassanain, managing director of SaudiVax, said: “This is the beginning of a great effort to actually develop and manufacture vaccines and biologics in Saudi Arabia and deliver them to satisfy the needs of the Kingdom, the Middle East and Africa.
SaudiVax to increase halal vaccine availability in ME with FlexFactory from Cytiva
“The lack of vaccines, for regional diseases, and some of the essential biologics make our purpose clear. Working with Cytiva, we’ve been able to complete construction and qualification of the bioreactors — even during the COVID-19 pandemic.”
The annual Hajj and the year-round Umrah attract millions of pilgrims to the Kingdom of Saudi Arabia every year. In 2019, more than 21.5 million religious pilgrims visited the region, and over 650,000 electronic Umrah permits have already been issued this year, even during the COVID-19 pandemic.
Such large-scale gatherings are a known risk for the spread of communicable diseases, with millions of people spending extended time in close proximity during pilgrimage events or at crowded accommodations. Past events have resulted in flu and meningococcal outbreaks.
Approximately half of Hajj pilgrims are older than 56 with pre-existing health conditions. Additionally, many travel from countries that don’t have advanced health systems, disease surveillance or prevention education, so an outbreak of any communicable disease could easily be an epidemic before it is detected. Both the Hajj and Umrah have been linked to local and international outbreaks of meningococcal disease.
An important religious and cultural consideration is making halal-certified vaccines, those without any animal products. SaudiVax will use Cytiva’s flexible solution to manufacture halal-certified as well as a therapy based on mAbs for the respiratory pathogens.
Between April 2012 and Sept. 1 2020, 2,577 cases of MERS-CoV, including 935 deaths, have been reported by health authorities worldwide.
Progress in the COVID-19 environment
COVID pandemic-induced travel restrictions and social distancing regulations meant that the SaudiVax team could not attend the Factory Acceptance Testing (FAT) at Cytiva’s site in Sweden prior to delivery. Instead, a remote solution was rapidly developed, using cameras, digital platforms and an interactive online environment.
This first-of-its-kind test from Cytiva’s Umea site experience allowed Cytiva to reach a wider SaudiVax team, with more in-depth knowledge of available Cytiva instruments, leading to shorter start-up and time-to-market timelines.
Olivier Loeillot, senior vice president, Cytiva, says: “We understood that accelerating the approval of this FlexFactory was key to the strategy of SaudiVax and other clients, which we quickly acted upon by setting up a remote ‘near-live’ FAT process.
“This way, we were able to meet quality requirements and the timeline for SaudiVax, while ensuring the health and safety of our and the SaudiVax’s team during the COVID-19 pandemic.”
The SVBC is located in the King Abdullah University of Technology Research and Technology Park (KAUST-KRTP) in Thuwal, north of Jeddah, Saudi Arabia. Preparations are ongoing to begin production in 2022. — SG
Source : Saudi Gazette
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