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Vaccine academy / Vaccine Manufacturing

Vaccine Manufacturing

Vaccine Manufacturing Process

Vaccine manufacturing process is a complex journey; it involves 70% of manufacturing time in Quality Control, and several hundred quality tests. 1

 

Vaccine manufacturing involves the following steps: 2

 

Raw material reception

Raw material are either used in key production steps as fermentation, purification or as an integral part of the vaccine. Up to 160 raw materials could be used to produce some vaccines.

 

Active ingredient manufacturing

Generation of the antigen** (active ingredient) is the most critical step in the production of high quality, safe and efficacious vaccines.

 

Coupling & Formulation

During the formulation, the antigen is coupled with stabilizers, preservatives, adjuvant to enhance the immune response, facilitate vaccines administration & ensure vaccine stability in time.

 

Filling

Vaccines are filled aseptically, in a vial or a syringe, to endure sterility. Vials are closed using sterile stoppers and crimped to maintain sterility. Unstable liquid vaccines are lyophilized. During this step, water is removed from the liquid to allow stability. In this case, the vaccine will have to be reconstituted just before injection.

 

Packaging & lot release

Due to the diversity and complexity of regulatory requirements, across EU Member States and globally, vaccine syringes or vials are each time labelled and packed in a country-specific format (label, leaflet, carton). Following quality assurance confirmation that the product has been manufactured and tested in accordance with ad hoc procedures, a final authorization is given to release the product for distribution.

 

References:

  1. IFPMA website. Resources. Infographics. The complex journey of a vaccine. https://www.ifpma.org/resource-centre/the-complex-journey-of-a-vaccine. [ONLINE] Accessed on 2 Mar, 2021.
  2. Vaccines Europe website. How are vaccines produced? https://www.vaccineseurope.eu/about-vaccines/how-are-vaccines-produced. [ONLINE] Accessed on 2 Mar, 2021.

 

 

MAT-HK-2100263-1.0-03/2021