The consistency approach for quality control of vaccines - A strategy to improve quality control and implement 3Rs

Biologicals

Volumn 39, Issue 1, 2011, Pages 59-65

  De Mattia, Fabrizio ^a   Chapsal, Jean Michel ^b   Descamps, Johan ^c   Halder, Marlies ^d   Jarrett, Nicholas ^e   Kross, Imke ^a   Mortiaux, Frederic ^c   Ponsar, Cecile ^c   Redhead, Keith ^f   McKelvie, Jo ^g   Hendriksen, Coenraad ^h  

^a INTERVET INTERNATIONAL BV   (Netherlands)

^b SANOFI PASTEUR   (France)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^d JOINT RESEARCH CENTRE   (Italy)

^e EUROPEAN MEDICINES AGENCY   (United Kingdom)

^f Intervet/Schering Plough Animal Health   (United Kingdom)

^g Evitas Service   (Ireland)

^h NETHERLANDS VACCINE INSTITUTE   (Netherlands)

Author keywords

3R; Consistency; In vitro; Quality control; Vaccine

Indexed keywords

CLOSTRIDIUM TOXIN; DIPHTHERIA TOXOID; IMMUNOLOGICAL ADJUVANT; INACTIVATED VACCINE; PERTUSSIS VACCINE; TETANUS TOXOID; VACCINE;

ANTIGEN PURIFICATION; BATCH PROCESS; CONFERENCE PAPER; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; DRUG SURVEILLANCE PROGRAM; ETHICS; FUNDING; GOVERNMENT REGULATION; HUMAN; IMMUNE RESPONSE; LICENSING; NONHUMAN; PRIORITY JOURNAL; PROCESS MONITORING; QUALITY CONTROL; RISK BENEFIT ANALYSIS; SHELF LIFE; STANDARD; TOXICITY TESTING; VACCINE PRODUCTION; VALIDATION PROCESS;

ANIMAL TESTING ALTERNATIVES; ANIMALS; HUMANS; QUALITY CONTROL; RESEARCH DESIGN; VACCINES; VETERINARY MEDICINE;

ANIMALIA;

EID: 79551571017     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.12.001     Document Type: Conference Paper

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