Viral Safety Issues in the Production and Manufacturing of Human Immunoglobulin Preparations from Equine Plasma/Serum.

The current Russian and foreign pharmacopoeias either do not provide any information about existing types of viral diseases in horses or do not present it in full. Data of modern domestic and foreign literature was used to prepare the most complete list of viruses that cause equine diseases including 36 infectious agents, 25 of which are pathogenic for humans, 13 of the 25 of which are widespread throughout Russia. Information is provided on the magnitudes of the disease incubation periods (which are most often within one month), the external clinical signs of these diseases (which can also be asymptomatic), and the maximum possible concentrations of viruses in the blood of horses with these diseases (which can reach 8 log conventional units/mL of blood). This information is offered for use in critical production stages of heterologous immunoglobulin drugs for medical use to assure viral safety.

Ensuring Viral Safety of Equine Immunoglobulins during Production.

Equine blood plasma/serum and intermediates must be monitored for the presence of live viruses pathogenic in humans during production of equine immunoglobulins. Information concerning low-cost and simple methods for the detection of live horse viruses pathogenic and non-pathogenic to humans was gained using data of modern domestic and foreign literature. These methods are based on cultivation of these viruses on sensitive biosystems. The presented information can be used to set up blood plasma/serum control of horses at different stages of immunoglobulin production, i.e., when taking blood from horses during their quarantine period, when collecting blood from immunized horses, and before bottling the medicinal intermediate in the primary package.

[Spectrum, clinical features, diagnosis of opportunistic and comorbid pathology in HIV-infected patients admitted to infection hospital of Moscow].

AIM: To analyse structure, clinical features, diagnosis of opportunistic and concomitant diseases in patients with HIV infection admitted to infection hospital of Moscow. MATERIAL AND METHODS: A total of 4155 patients with HIV infection (1518 of them with AIDS) most of them (89%) at the age of 20-39 years were treated in Moscow AIDS hospital in 2006-2007. The examination included standard blood and urine tests, device diagnosis, immunological, bacteriological and molecular investigations of biological materials for detection of opportunistic infections. Cell-mediated immunity was also studied. HIV infection resulted in a lethal outcome in 255 (6.1%) inpatients. RESULTS: Leading causes of hospitalization of patients at early stages of HIV infection were bacterial bronchitis or pneumonia, hepatic pathology (chronic viral hepatitides, alcohol-associated diseases), sepsis. One-third of the inpatients were at AIDS stage characterized by tuberculosis (66.3%), visceral candidosis (12%), manifest cytomegalovirus infection (10.1%), cerebral toxoplasmosis (9.2%), pneumocystic pneumonia (5.5%). The number of HIV-infected persons with atypical mycobacteriosis, lymphoproliferative diseases, brain tumors increased. Chronic hepatitis C prevailed among liver damage cause in HIV infection, it also often caused hospitalization and death of patients. 60.3% patients having HIV infection who died without AIDS stage had hepatic cirrhosis. Tuberculosis was a leading cause of severe pulmonary pathology, most frequent opportunistic disease, main cause of death in patients with HIV infection. One-third of patients had generalized tuberculosis. Tuberculosis was diagnosed in more than 40% HIV-infected patients with pulmonary lesion, in 65% AIDS patients, 36% dead AIDS patients. CONCLUSION: To render effective anti-HIV treatment, infection hospital must be equipped with facilities providing device tests, molecular diagnosis, modern etiotropic and pathogenetic medication.

[Time course changes in cytokines content and gas composition in blood of patients with salmonellosis and acute shigellosis].

AIM: To study changes in serum concentrations of interleukines (IL) and tumor necrosis factor alpha (TNFa) in the course of acute moderate and severe shigellosis and salmonellosis; to elicit their correlation with disorders of gas and electrolyte blood composition and acid-base balance (ABB). MATERIAL AND METHODS: A total of 39 patients with salmonellosis and 32 patients with acute shigellosis admitted to infectious hospital N 2 entered the study. The following parameters were assessed: serum concentrations of IL-1, IL-IO and TNFa; ABB, gas and electrolyte blood composition; leucocytic intoxication index (LII). The tests were made on the disease day 2-3 and 6-7 (in severe salmonellosis on day 10-11). RESULTS: In moderate salmonellesis and acute shigellosis the level of proinflammatory cytokines (IL-1 and TNFa) diminished while in severe acute intestinal infection their concentration was high reflecting imbalance of immune response. Content of IL-10 depends on etiology and severity of the course of infectious process - the highest IL-10 concentrations were found in patients with severe salmonellosis on the disease day 10-11. A direct correlation was confirmed between IL-1, TNFa and LII in the disease onset in all patients with acute intestinal infections. CONCLUSION: An important role of IL-1, IL-10 and TNFa in pathogenesis of bacterial intestinal infections is confirmed. A correlation exists between blood gas composition and concentration of cytokines.