GMP UPDATE 2021 - Corona Vaccine Production

GMP UPDATE 2021 - Corona Vaccine Production

GMP UPDATE 2021 - Corona Vaccine Production

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Almost one year after registering first mRNA-based vaccine, GMP compliant manufacturing of this new pharmaceutical product was established at companies such as BioNTech [1] or Moderna.

 

After successfully passing clinical trials phase I-III EMA issued authorization in December 2020. After market launch companies start their market monitoring (called “phase IV” or pharmacovigilance) to register adverse effects which have not been covered in clinical trials.

 

To establish and maintain GMP compliant mRNA vaccine manufacturing initial validation must be continuously monitored for routine production.

 

Through newspaper articles we heard that storage temperature of mRNA vaccine changed from -80°C to refrigerator temperature enabling storage for one month [2]. This change must be based on stability data derived from a process called on-going stability examination.

 

Since companies such as BioNTech and Moderna do not produce all excipients on their own, several critical suppliers must be qualified according to GMP standards. Furthermore, batch size of mRNA vaccine production was increased due to high demand which also must be performed in compliance to GMP.

 

 

In this training seminar you will learn:

 

-          Process of pharmacovigilance after drug launching

-          Routine drug manufacturing and its GMP maintenance

-          On-going stability examination

-          Product and process change of mRNA vaccine production (shelf-life and batch size)

-          GMP qualification of external suppliers

 

Participation in this seminar includes success control and receive of certificate of completion 

including all relevant keywords for your records and application reference.  

 

[1]

https://www.sueddeutsche.de/gesundheit/gesundheit-darmstadt-arzneimittelrechtliche-erlaubnis-fuer-biontech-werk-erteilt-dpa.urn-newsml-dpa-com-20090101-210128-99-211654

 

[2]

https://www.pharmazeutische-zeitung.de/kuehlschrank-reicht-fuer-comirnaty-125696/

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