One of the most important QC tests of whole-cell pertussis vaccine (WCPV) is potency test. In this regard, mouse protection test (MPT) is the current potency method, which is associated with severe animal distress and large variability in results. The purpose of this study was to assess Pertussis Serological Potency Test (PSPT) as a serological alternative method to intracerebral challenge in M...

stability studies play a critical role in assuring product quality at all points in the vaccine life cycle. these studies used to determine vaccine expiry date and vaccine efficacy. accelerated stability and long term stability study performed for three batches of trivalent oral poliomyelitis vaccine (opv) and three batches of monovalent opv (type1) manufactured by razi institute. after samplin...

vaccination against mumps is included in world health organization (who) program of global immunization. safety and efficacy of vaccines must be confirmed by control units in charge of public health. in iran, the secondary control on potency of vaccine has not been set up yet. we decided to overcome this problem by developing who and nibsc methods in food and drug control lab. ‎nine dilutions o...

  Mass vaccination against viral infections such as mumps is a very noticeable and appropriate attempt in common health. Mumps infection has severe complications like deafness, infertility and meningitis. Attenuated live vaccine of mumps is produced and used to prevent the problems. Viral content in the monovalent vaccine is assayed with different methods. Nowadays international standards intro...

The development of reliable and clinically relevant potency assays is essential to the practice of safe and effective allergen-specific immunotherapy. Allergen standardization in the United States is based on the establishment of a national reference assigned with a biological potency unit to which manufacturers' products are compared using validated relative potency assays. This ensures, at le...

Adult rhesus monkeys (Macaca mulata) were vaccinated with four inactivated rabies vaccines, including two cell culture vaccines, one zonal purified cell culture vaccine, and a 10% extracted duck embryo vaccine. The vaccines were potency tested by both National Institutes of Health (NIH) and Habel methods and passed one or both tests. However, a vaccine having acceptable potency by one method fr...

Vaccine manufacturers require more rapid and accurate tools to characterize the potency and stability of their products. Currently, the gold standard for influenza vaccine potency is the single radial immunodiffusion (SRD) assay, which has inherent disadvantages. The primary objective of this study was to investigate the ability of the VaxArray Influenza (VXI) seasonal hemagglutinin (sHA) poten...

The single radial immunodiffusion assay has been the accepted method for determining the potency of inactivated influenza vaccines since 1978. The worldwide adoption of this assay for vaccine standardisation was facilitated through collaborative studies that demonstrated a high level of reproducibility and its applicability to the different types of influenza vaccine being produced at that time...