摘要:
Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern techniques grow the virus in mammalian cell culture e.g. on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.
摘要:
Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern techniques grow the virus in mammalian cell culture e.g. on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.
摘要:
The present invention relates to a culture medium for disperse mycobacteria comprising at least one detergent and an antifoam agent, whereby said antifoam agent is a member of the silicone family. In addition, the invention provides for methods for the activation of dipressed mycobacteria, for obtaining a standardized mycobyterial culture or for the production of (a), purified protein derivates(s) (PDD) which comprise the cultivation of mycobacteria in the active medium disclosed herein. Furthermore, the use of standardized mycobacterial cultures obtained by the method of the invention for the preparation of pharmaceutical or diagnostic compositions is described.
摘要:
A scrogroup C meningococcal conjugate antigen is co-administcrcd with a pneumococcal saccharide conjugate which is in a liquid form. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae ; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.
摘要:
Animal cells are described which can be infected by influenza viruses and which are adapted to growth in suspension in serum-free medium. Processes for the replication of influenza viruses in cell culture using these cells are furthermore described, as well as vaccines which contain the influenza viruses obtainable by the process or constituents thereof.
摘要:
Verfahren zur Herstellung eines aktiven Bestandteils eines Impfstoffs, Schritte umfassend, bei denen man (a)MDCK-Zellen, die in Serum-freien Medium kultiviert wurden, mit einem Primärvirus infiziert, um einen Saatvorrat eines Virus zu erzeugen; (b) eine Kultur von MDCK-Zellen mit dem Saatvorrat des Virus infiziert; und (c) die Kultur von MDCK-Zellen in einem kommerziellen Maßstab unter Bedingungen kultiviert, die eine Vermehrung der Viren ermöglichen.
摘要:
The inventor has realised that certain pathogens can grow in mammalian cells, in particular Vero cells, and that these pathogens could pose a contamination risk when producing vaccine antigens in these cells. The invention thus provides methods to test for these pathogens.