GMP News - Blood / Biologics and ATMP

18.02.13

Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

In Febraury 2012 EMA's "Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture" became official. The scope of this document is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture. More details can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor IX Products

In February 2012 the "Guideline on clinical investigation of recombinant and human plasma-derived factor IX products" came into effect. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor IX products. More can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor VIII Products

The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.

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18.02.13

Plasma-derived Medicinal Products

Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.

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