Stability testing of vaccines: Developing Countries Vaccine Manufacturers' Network (DCVMN) perspective.
Stability testing is an integral part of the vaccine manufacturing process and is crucial for the success of immunization programs. WHO (World Health Organization) has recently published guidelines on the stability testing of vaccines. These guidelines enlist scientific basis and principles for stability testing at various stages like development, pre-clinical, clinical, licensing, lot release and post-licensure monitoring. DCVMN (Developing Countries Vaccine Manufacturers' Network) is an international body of developing countries vaccine manufacturers and has viewpoints on technical and administrative issues in stability testing of vaccines. We here highlight viewpoints, possible roles and global expectations of DCVMN in the area of stability testing of vaccines.
Jadhav
Suresh S
SS
Serum Institute of India Ltd., Hadapsar, Pune 411028, Maharashtra, India. ssj@seruminstitute.com
Dogar
Vikas
V
Gautam
Manish
M
Gairola
Sunil
S
D015415:Biomarkers / Q000032:analysis; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration; D019049:Developed Countries; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D011499:Protein Processing, Post-Translational / Q000502:physiology; D012957:Societies, Pharmaceutical / Q000458:organization & administration; D013997:Time Factors; D014612:Vaccines / Q000737:chemistry / Q000493:pharmacokinetics*; D014944:World Health Organization / Q000458:organization & administration
D015415:Biomarkers; D014612:Vaccines