Immunological products

Immunological products for the treatment of animal diseases that are subject to Community prophylactic measures. 

Immunological products comprise a group of pharmaceutical preparations with diverse origins but with a common pharmacological purpose the enhancement of a recipienf s immune status in a manner that provides immunity to infectious disease. The immunological products that are generally available today are of three types vaccines, immunosera and human immunoglobulins. 

In addition to the three types of immunological product that are generally available there are two further types synthetic peptide vaccines and monoclonal antibodies. Both have been extensively investigated but neither has, as yet, a place in conventional prophylaxis or therapeutics. 

British Medical Association and Pharmaceutical Press (1997) TheBritishNationalFormulary. London BMA. (This publication contains a useful section on immunological products. New editions appear at intervals.)... 

British Pharmacopoeia (1993) London Her Majesty s Stationery Office. (The British Pharmacopoeia contains edited versions of the monographs for immunological products that appear in the European Pharmacopoeia.)... 

Datapharm Publications Ltd (1996) The Data Sheet Compendium. London. (This publication contains reproductions of the Data Sheets of immunological products that are licensed by the Medicines Control Authority.)... 

There is the potential to develop a protective vaccine/immunization programme for each and every infectious disease. Whether or not such vaccines are developed and deployed is related to the severity and economic impact of the disease upon the eommunity as well as the effects upon the individual. Principles of immunity and of the produetion and quality control of immunological products are discussed in Chapters 14 and 15, respeetively. 

No medical or therapeutic procedure comes without some risk to the patient. All possible steps are taken to ensure safely, quahty and efficacy of vaccines and immunological products (Chapter 15). The risks associated with immunization procedures must be constantly reviewed and balanced against the risks of, and associated with, contracting the disease, hi this respect, smallpox vaccination in the UK was abandoned in the mid 1970s as the risks associated with vaccination then exceeded the predicted number of deaths that would follow importation of the disease. Shortly after this, in 1980, The World Health Assembly pronounced the world to be free of smallpox. Similarly, the incidence of paralytic poliomyelitis in the USA and UK in 1996 was low but the majority of cases related to vaccine use. As the worldwide elimination of poliomyelitis approaches, there is much debate as to the value of the vaccine outside of an endemic area. 

EMEA (1998) Note for Guidance environmental risk assessment for veterinary medicinal products other than GM-containing and immunological products. EMEA/CVMP/ 055/96. European Agency for the Evaluation of Medicinal Products, London... 

From time to time, the Committee received submissions related to vaccines or immunological products. When considering these, the Committee felt the need to seek advice of experts in that special field. Therefore, in November 1969 it was decided to set up a Vaccine Advisory Group. This initiative ultimately culminated in the establishment of the Subcommittee on... 

Passive immunization consists of transfer of immunity to a host using preformed immunologic products. From a practical standpoint, only immunoglobulins have been used for passive immunization, since passive administration of cellular components of the immune system has been technically difficult and associated with graft-versus-host reactions. Products of the cellular immune system (eg, interferons) have also been used in the therapy of a wide variety of hematologic and infectious diseases (see Chapter 56). 

Analytical, pharmaco-toxicol. and din. standards and protocols. Title I Non-immunological products ... 

Roitt IM (1993) OKT3 Immunology, production, pruification and pharmacokinetics. Clin Transplant 7 367-373. 

Use in the production of vaccines As assay organisms to determine antibiotic, vitamin and amino acid concentrations Quality control of immunological products Assay methods Sterilization methods Sterilization monitoring and validation procedures Sterility testing Assessment and calculation of sterility assurance Aseptic manufacture... 

Vaccines are by far the most important immunological products. They have enabled the control or eradication of numerous infectious diseases affecting humans and their domesticated animals. For example, the systematic application of smallpox vaccine, deployed under the aegis of the World Health Organization, achieved the eradication of... 

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