title: Review of the current use and evaluation of cell substrates for producing biologicals in selected countries.
abstract: In 2010, the WHO guidance document for the evaluation of cell substrates for producing biologicals was replaced with updated recommendations and in May 2013 an implementation workshop on the new recommendations was held in Beijing, China. As part of this workshop, a survey of the use and evaluation of cell substrates for producing biologicals was undertaken and the information obtained was updated in June 2014. The purpose of survey was to capture the status of national requirements related to cell substrates in various countries with particular emphasis on whether or not the updated WHO recommendations had been, or were to be, incorporated into national requirements. This paper reports the outcome of the survey and is based on information provided by regulators in eleven countries. Since the publication of the updated WHO recommendations, several activities such as the implementation workshop and publications have been undertaken by the WHO. The aim of these activities, including the publication of this article, is to contribute to the implementation of WHO recommendations so as to reduce regulatory gaps between national requirements and globally agreed expectations.
authors.affiliation: World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland. Electronic address: kangh@who.int.
authors.forename: Hye-Na
authors.initials: HN
authors.lastname: Kang
authors.affiliation: Institute for Biological Product Control, National Institutes for Food and Drug Control, People's Republic of China.
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.affiliation: Centro para el Control Estatal de la Calidad de los Medicamentos, Cuba.
authors.forename: Violeta Pérez
authors.initials: VP
authors.lastname: Rodríguez
authors.affiliation: Scientific Center for Expertise of Pharmaceuticals for Medical Use, Ministry of Public Health, Russia.
authors.forename: Kirill
authors.initials: K
authors.lastname: Mefed
authors.affiliation: Department of Biochemistry & Cell Biology, National Institute of Infectious Diseases, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Hanada
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea.
authors.forename: Kwang-Soo
authors.initials: KS
authors.lastname: Ahn
authors.affiliation: Central Drugs Standard Control Organization, India.
authors.forename: Shri Jayant
authors.initials: SJ
authors.lastname: Gangakhedkar
authors.affiliation: Vaccine Potency Section, Food and Drug Control Laboratories & Research Center, Islamic Republic of Iran.
authors.forename: Saeed Reza
authors.initials: SR
authors.lastname: Pakzad
authors.affiliation: National Quality Control Laboratory of Drug and Food, National Agency of Drug and Food Control, Indonesia.
authors.forename: Elizabeth Ika
authors.initials: EI
authors.lastname: Prawahju
authors.affiliation: National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea.
authors.forename: Naery
authors.initials: N
authors.lastname: Lee
authors.affiliation: Institute of Biological Products, Ministry of Public Health, Thailand.
authors.forename: Supaporn
authors.initials: S
authors.lastname: Phumiamorn
authors.affiliation: Biologics and Genetic Therapies Directorate, Health Canada, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Nemec
authors.affiliation: Institute for Biological Product Control, National Institutes for Food and Drug Control, People's Republic of China.
authors.forename: Shufang
authors.initials: S
authors.lastname: Meng
authors.affiliation: World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland.
authors.forename: Ivana
authors.initials: I
authors.lastname: Knezevic
mesh_terms: D001688:Biological Products / Q000627:therapeutic use; D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards*; D003226:Congresses as Topic; D006801:Humans; D014944:World Health Organization
chemical_list: D001688:Biological Products
keywords: Biological products; Cell substrates; Implementation workshop; Survey; WHO