Biologicals

Technical report series: cells and tissues

Requirements for the use of animal cells as in vitro substrates for the production of biologicals (Addendum 2003)

WHO Technical Report Series, No. 927, 2005

Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Proposed replacement of TRS 878, Annex 1

Title 2: Requirements for the use of animal cells as in vitro substrates for the production of biologicals-Addendum 2003)

Upcoming events

WHO Informal Consultation on Regulatory considerations for evaluation of Ebola Vaccines intended for emergency use, WHO/HQ Geneva, Switzerland, 18-19 March 2015

WHO Informal Consultation on Stability Evaluation of Vaccines for use in a Controlled Temperature Chain, WHO/HQ Geneva, Switzerland, 24–26 March 2015

WHO Informal Consultation on Amendment for Similar Biotherapeutic products of monoclonal antibodies, WHO/HQ Geneva, Switzerland, 27–28 April 2015

WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WHO/HQ Geneva, Switzerland, 29–30 April 2015

Contacts

Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
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