SaudiVax, which is considered to be the first vaccine biotech in the Kingdom, is also poised to become its first developer and manufacturer of halal vaccines and biotherapeutics. Initially, it hopes to turn out 5 to 7 million doses per year.

The production base for the vaccines will be located at the King Abdullah University of Science and Technology (KAUST) campus, north of Jedda, and output will be earmarked for the Middle East and North Africa (MENA) region. According to reports, the facility is expected to be operational by 2023, with fill & finish to start in March of that year and API manufacturing in December.

In a three-phase process, Merck will train SaudiVax employees at its M Lab collaboration center in Molsheim, France, and its end-to-end facility in Martillac, France. The first phase will focus on equipment without attention to the process or GMP conditions. The second will include the full process training in non-GMP conditions in one of the German company’s pilot labs, with the final phase to include training under GMP conditions.

The German group’s task will be finding a replacement for porcine gelatin, which is used as a stabilizer in the production of various vaccines, including the nasal flu vaccine, measles, mumps, and rubella vaccine (MMRVaxPro), as well as the shingles vaccine and some chickenpox vaccines. Questions have been raised in the Middle East as to whether the vaccines are halal (accepted under Islamic law).

Sebastien Ribault, head of end-to-end CDMO Services at Merck, told Bioprocess International Magazine that the manufacturing process for vaccines will be the same as that for other products, with particular attention paid to raw materials and components to make sure they conform to the halal principles.

Author: Dede Williams, Freelance Journalist