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)

FOR PUBLIC CONSULTATION:

COMMENTS TO BE RECEIVED BY 15 JUNE 2012

NEW PUBLICATIONS

UPCOMING EVENTS

WHO Collaborating Centers on Standardization on Regulatory Evaluation of Vaccines & Biotherapeutic Products: 1st meeting, Geneva, 24-26 April 2012

WHO Workshop on implementing WHO Guidelines on evaluating similar biotherapeutic products (SBPs), Xiamen, China, 28-30 May 2012

WHO Informal Consultation on the revision of the recommendations to assure the Quality, Safety and Efficacy of biological products prepared by recombinant DNA technology, Xiamen, China, 31 May-1 June 2012

CONTACTS

Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
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