ウイルス安全性関連規制

試験名:ウイルスクリアランス関連
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMA/CHMP/BWP/706271/2010, 21 July 2011 Guidance on Plasma-derived Medicinal Products

EMA/CHMP/BWP/268/95, 14 Feb 1996 Note for Guidance on Virus Validation Studies: the Design, Contribution and Interpretation of Studies Validation the Inactivation and Removal of Virus

WHO Technical Report, Series No.924, 2004 Guideline on viral inactivation and removal procedures intended to assure the viral safety of human blood products.

医薬発第1047号(1999.8.30)血漿分画製剤のウイルスに対する安全性確保に関するガイドラインについてついて “Guideline on safety assurance against virus of plasma products”

(第十七改正)日本薬局方参考情報  日局生物薬品のウイルス安全性確保の基本要件

試験名:感染性試験(延長PG-4 S+L- 細胞フォーカス解析)/レトロウイルス否定試験
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

試験名:感染性試験(Mus Dunni細胞共培養 + PG-4フォーカス試験) /レトロウイルス否定試験
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

試験名:感染性試験(293細胞共培養 + PERT法)/レトロウイルス否定試験
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products

試験名: 超遠心及びQ-PERTアッセイによる逆転写酵素活性の検出と定量 /レトロウイルス否定試験
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

試験名:透過型電子顕微鏡(TEM)観察
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

試験名:in vitroウイルス否定試験 (3種・4種の指示細胞を用いた、14日間・28日間 in vitro ウイルス否定試験)
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

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

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

医薬審第873号(2000.7.14):ICH Q5Dの翻訳 生物薬品(バイオテクノロジー応用医薬品/生物起源由来医薬品)製造用細胞基材の由来、調製及び特性解析について

試験名:成熟マウス、乳のみマウス、発育鶏卵を用いた In vivo ウイルス否定試験
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

厚生労働省告示 第274号 (2020.7.21) 生物学的製剤基準

試験名:ハムスター/マウス/ラット抗体産生試験 (HAP / MAP / RAP)
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

試験名:細胞種特異ウイルス試験 (特定ウイルス解析 (NAT法))
ICH Q5A(R1) Viral safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

EMA/CPMP/BWP/706271/2010, 21 July 2011 Guidance on Plasma-derived Medicinal Products.

EMEA/CPMP/BWP/39849/2005, 24 July 2008 Guidance on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products.

FDA CBER, 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

WHO Technical Report, Series No.924, 2004 Guideline on viral inactivation and removal procedures intended to assure the viral safety of human blood products.

医薬審第329号(2000.2.22):ICH Q5A(R1)の翻訳 ヒト又は動物細胞株を用いて製造されるバイオテクノロジー応用医薬品のウイルス安全製評価について

医薬発第1047号(1999.8.30)血漿分画製剤のウイルスに対する安全性確保に関するガイドラインについてついて “Guideline on safety assurance against virus of plasma products”

薬食審査発第1107001号/薬食安発第1107001号/薬食監発第1107001号/薬食血発第1107001号(2003.11.7)血漿分画製剤のウイルス安全性対策について“About virus safety of plasma products”

厚生労働省告示第210号(2003.5.20)薬事法 生物由来原料基準

試験名:ウシウイルス否定試験
EMA/CHMP/BWP/457920/2012 Rev. 1, 30 May 2013 Use of bovine serum in the manufacture of human biological medicinal products.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

9CFR113.53 Requirements for ingredients of animal origin used for production of biologics.

9CFR113.47 Detection of extraneous viruses by the fluorescent antibody technique.

試験名:ブタウイルス否定試験
EMA/CHMP/BWP/814397/2011, 20 Feb 2014, Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products.

FDA February 2010 Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

9CFR113.53 Requirements for ingredients of animal origin used for production of biologics.

9CFR113.47 Detection of extraneous viruses by the fluorescent antibody technique.

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