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.
Porcine gelatin is used as a stabilizer in the production of various vaccines,包含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.”
The training plan includes three phases and during this time, Merck will support the training of SaudiVax employees in itsM Lab collaboration center位于法国Molsheim，以及法国马蒂拉克的端到端设施。
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.