SaudiVax has selected Merck KGaA to help design a Saudi-based facility to localize manufacturing of vaccines and biologics in the region.
SaudiVax is expected to become the first developer and manufacturer of halal biotherapeutics and vaccines in Saudi Arabia and has turned to German Merck’s contract development manufacturing (CDMO) services and single-use technologies – MilliporeSigma – to help design a multi-modality manufacturing plant.
The plant will be located at the King Abdullah University of Science and Technology (KAUST) campus, north of Jeddah. The facility will produce biologics and vaccines for the Middle East and North Africa (MENA) region.
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Porcine gelatin is used as a stabilizer in the production of various vaccines, including the nasal flu vaccine, measles, mumps, and rubella vaccine (MMRVaxPro), shingles vaccine, and some chickenpox vaccines. In turn, this raises questions regarding whether the vaccine is halal, or accepted under Islamic law.
It has not been disclosed what SaudiVax will use as an alternative to a pork-based stabilizer but Sebastien Ribault, head of end-to-end CDMO Services at Merck told us “Halal means ‘what is authorized.’ The manufacturing process is exactly the same as that for other products, with particular attention to the various raw materials and components to make sure they conform to the halal principles.â€
Three phases
The training plan includes three phases and during this time, Merck will support the training of SaudiVax employees in its M Lab collaboration center located in Molsheim, France, as well as its end-to-end facility in Martillac, France.
“Phase one is a training on equipment, leveraging Merck’s M Lab Collaboration Centers without the constraints of the process or GMP conditions. This will be primarily unit operation by unit operation. Phase two will include the full process training in non-GMP conditions in one of our pilot labs. Finally, phase three includes training in GMP conditions in one of our CDMO centers, followed by a follow-up visit to the SaudiVax site in GMP conditions,†said Ribault.
The facility is anticipated to be operational in 2023, with fill & finish expected to be up and running in March and API manufacturing in December.