Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Strasbourg and its related General European Official Medicines Control Laboratories (OMCLs) Network (GEON). The EDQM works in cooperation with the European Medicines Agency (EMA) and the World Health Organisation (WHO). All of these institutions have one main goal – to protect public health in Europe and around the world. One of the more important effects of the harmonisation of pharmaceutical law in Europe was the introduction of the mutual recognition principle for the Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) certificates in the European Union. The National Veterinary Research Institute (NVRI) in Poland is an example of an OMCL laboratory within the Veterinary Batch Release Network (VBRN) that issues the European certificates. The NVRI is actively involved in the batch release of immunological veterinary medicinal products (IVMPs), with approximately 1,800 certificates for IVMPs issued per year. It is also one of only four veterinary OMCLs that perform Post Marketing Surveillance (PMS) studies including approximately 47 IVMPs per year. All the results of the testing data are sent to the Chief Veterinary Officer, and also to the electronic Network platforms of the EDQM, which enables transparent information exchange.

OBJECTIVE To establish a method for evaluation of the efficacy of a classical swine fever virus (CSFV) subunit vaccine in rabbits as determined via humoral immune responses to the virus. ANIMALS 40 specific pathogen–free rabbits. PROCEDURES Rabbits were randomly assigned to 4 groups (10 rabbits/group) for SC injection of 0.05, 0.1, and 0.2 mL of a CSFV subunit E2 vaccine (representing 1.15, 2.3, or 4.6 μg of E2 protein/dose, respectively) or saline (0.9% NaCl) solution. Blood samples were collected 21 days after vaccination for measurement of the antibody response against CSFV via ELISA and virus neutralization methods. On the same day, the CSFV Chinese (C) strain was injected into an ear vein. Vaccine efficacy was determined by monitoring of rabbits for pyrexia for 4 days and measurement of viral copies in spleen lysates at the end of the study. Reproducibility of the antibody response was tested with 2 other batches of the vaccine at the minimum immunization dose identified for the initially tested batch. RESULTS The E2 protein dose of the initially tested vaccine was positively correlated with the antibody response and protection rate in rabbits. The identified minimum immunization dose per rabbit was 0.1 mL, representing an E2 protein content of approximately 2.3 μg, and reproducibility of the antibody response to vaccination with the 2 other batches at this dose was good. CONCLUSIONS AND CLINICAL RELEVANCE A method was established in rabbits for evaluation of the efficacy of a CSFV subunit vaccine that could help in the optimization of later large-scale vaccine production and quality control processes as well as in the clinical application of the vaccine.

Susceptibility results for Pasteurella multocida and Streptococcus suis isolated from swine clinical samples were obtained from January 1998 to October 2010 from the Animal Health Laboratory at the University of Guelph, Guelph, Ontario, and used to describe variation in antimicrobial resistance (AMR) to 4 drugs of importance in the Ontario swine industry: ampicillin, tetracycline, tiamulin, and trimethoprim–sulfamethoxazole. Four temporal data-analysis options were used: visualization of trends in 12-month rolling averages, logistic-regression modeling, temporal-scan statistics, and a scan with the “What’s strange about recent events?” (WSARE) algorithm. The AMR trends varied among the antimicrobial drugs for a single pathogen and between pathogens for a single antimicrobial, suggesting that pathogen-specific AMR surveillance may be preferable to indicator data. The 4 methods provided complementary and, at times, redundant results. The most appropriate combination of analysis methods for surveillance using these data included temporal-scan statistics with a visualization method (rolling-average or predicted-probability plots following logistic-regression models). The WSARE algorithm provided interesting results for quality control and has the potential to detect new resistance patterns; however, missing data created problems for displaying the results in a way that would be meaningful to all surveillance stakeholders.

Using radioimmunoassay methods, quality control criteria were applied to monoclonal antibodies produced to measure porcine immunoglobulins by quantitative ELISA. Porcine IgM and IgA were purified to homogeneity and were used to produce murine hybridomas that secreted antibodies against IgM, IgA, and immunoglobulin light chains. A competitive ELISA was developed to measure IgM, and a sandwich ELISA was to quantify IgA in serum and colostrum. Both ELISA were tested for specificity, accuracy, sensitivity, and precision. Monoclonal antibodies were specific for porcine IgM or IgA in serum and colostrum, and competitive and sandwich ELISA fulfilled all validation criteria.

oxfendazole bolus for cattle, spray-dried lactose quality as influencing in vitro dissolution and bioavailability

Samples of feed ingredients were collected from the truck loads that arrived at feed processing unit located in Veterinary College and Research Institute, Orathanadu, Thanjavur, Tamil Nadu, India. Physical examination of collected samples was carried out prior to their chemical evaluation. Chemical evaluation of feed samples revealed that moisture content in maize grain ranged from 8.47% to 17.25% and high moisture was observed in samples received during the monsoon season (September to December). The crude protein content of protein supplements viz., soyabean meal, coconut oil cake, coconut deoiled cake (DOC), groundnut cake, groundnut deoiled cake, delinted decorticated cotton seed cake, sunflower deoiled cake and gingelly oil cake were 45.49, 25.11, 24.47, 36.92, 43.89, 35.36, 30.21 and 29.89 per cent on dry matter basis, respectively. The crude protein (% DMB) and crude fiber (% DMB) content of deoiled rice bran, rice bran and wheat bran were 15.47 and 16.13, 7.55 and 36.26, 14.26 and 9.47, respectively. Due to the high moisture content in maize grain 8.77% of the total truck loads of this ingredient received at the processing unit were rejected. Similarly, of the total truck loads of oil cakes received at the processing unit 20.93 % of soyabean meal, 12.5% of coconut oil cake, 20 % of coconut DOC, 22.22% of cotton seed cake and 33.33% of gingelly oil cake were rejected due to the lower crude protein and higher crude fiber contents. All truck loads of rice bran (100 %) were rejected due to their lower crude protein, higher crude fiber and Acid Insoluble Ash (AIA) content. The study thus revealed that quality control measures are essential to check the entry of poor quality raw materials before processing the feed.