MilliporeSigma to support SaudiVax in developing first halal vaccine

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.

该工厂将位于吉达北部阿卜杜拉科技大学(Kaust)校园大学。该设施将为中东和北非(MENA)地区产生生物制剂和疫苗。

图片:库存照片秘密

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.”

三个阶段

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。

“阶段是设备训练,利用Merck的M实验室协作中心,而没有加工或GMP条件的约束。这将主要是单位操作的单位操作。第二阶段将包括我们的一个试点实验室中的非GMP条件的完整流程培训。最后,第三阶段包括我们的CDMO中心中的GMP条件中的培训,然后在GMP条件下进行后续访问,“Ribault说。

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.

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