Vaccine Testing - Master Virus Seed Stock
Master Virus Seed Stock (MVSS) is prepared under GMP conditions from a qualified GMP Master or Working Cell Bank or in the case of a vaccine manufactured on eggs produced from an approved source. The issues of Identity, Purity and Stability require to be fulfilled for the MVSS. Identity should clearly present data which demonstrates the virus is as specified in the supporting data; this will involve a number of molecular and cell based assays to show the virus. Purity will seek to establish the MVSS is free from contaminating microorganisms. In the case of virus stocks this can be difficult due to the large amount of virus present in the sample which can hamper detection of adventitious contamination using cell and animal based tests. Neutralising antiserum is frequently required to allow detection of contaminating virus. Careful qualifications of these studies are required to demonstrate their utility.
Working Virus Seed Stock (WVSS) is similarly prepared under GMP conditions and the issues of Identity, Purity and Stability require to be fulfilled as for the MVSS.
|In vitro haemagglutinating virus test using Simian and Human cells||Test for the presence of extraneous agents by inoculation into continuous Simian kidney and Human cell cultures and observed for a period of 14 days.|
|Tests for Retroviruses using Infectivity Assays||These assays are used to detect xenotropic retroviruses in cell free supernatants. Murine Leukaemia virus (MLV) can exhibit a number of different tropisms for different cell lines. Of these tropisms, the term Xenotropic is applied for a virus which will infect cells of a different species such as human or monkey.|
|Pre-study to determine in vivo toxicity of the test material in adult mice, suckling mice and embryonated eggs||These tests are designed to detect the presence of adventitious viral agents by their ability to induce adverse affects in animals and eggs.|
|Detection of Mycoplasma by broth, agar and in vitro cell based methods||The mycoplasma test is designed to detect a wide range of mollicutes that may be present in a cell bank. A qualification of the test is required to ensure that the presence of the cell bank and associated components do not interfere with the detection of mollicutes. The US test specification is different for this test.|
|Real-time PCR for the detection of Human Viruses||This procedure is used to test samples for the presence of specific DNA or RNA, for example to look for adventitious viral agent contamination of a test sample or in the quantitation of contaminating residual DNA. The core viruses detected include: Epstein Barrvirus, Human Cytomegalovirus, Human Herpesvirus 6, Human Herpesvirus 7, Human Herpesvirus 8, Human T-cell leukemia virus Type 1 and 2, Human immunodeficiency virus Type 1 and 2, Hepatitis virus type A, Hepatitis virus type B, Hepatitis virus type C. Other Human viruses for which BioOutsource offer q-PCR detection includes Human metapneumovirus, Respiratory Syncytial virus, Human Polyomaviruses, Human Enteroviruses, Rhinovirus, Influenza virus, Bocavirus and Circovirus|
|Real-time PCR for the detection of Porcine and Bovine viruses||This procedure is used to test samples for the presence of specific DNA or RNA, for example to look for adventitious viral agent contamination of a test sample or in the quantitation of contaminating residual DNA.|
|Sterility Test||The sterility test is designed to detect a wide range of bacteria and fungi and is used to ensure the cell bank is free from microorganisms. The test may require qualification.|
|Tests for Retroviruses PERT||This method is employed to identify the presence of viruses, particularly of the family Retroviridae, in a given sample by detecting reverse transcriptase activity. BioOutsource offers a sensitive assay validated using both avian and mammalian retrovirus enzyme. Each sample matrix is pre-qualified and the assay uses both positive and negative controls and spiking of samples with the appropriate virus.|
|Tests for Retroviruses using Transmission Electron Microscopy (TEM)||The test is done by examination of a number of cells visually using TEM and is a catch all test for retrovirus particles.|
|Identity - Various methods depending on virus type||The volume is not less than the nominal volume in case of containers examined individually, or, in case of containers with a nominal volume of 2 mL or less, is not less than the sum of the nominal volumes of the containers taken collectively.|