Q5 Quality of Biotechnological Products Guideline

Q5A(R2)- Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

Q5A(R2) IWG- Training on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

Q5B- Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products.

Q5C- Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products.

Q5D- Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products.

Q5E- Comparability of Biotechnological/ Biological Products Subject to Changes in Their Manufacturing Process.

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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