Alglucosidase alfa is a recombinant form of human acid α -glucosidase and is produced by recombinant DNA technology using Chinese Hamster Ovary (CHO) cell culture.

As a routine, clarified suspensions of samples of epithelium, vesicular fluid or faeces suspected to contain swine vesicular disease virus must be inoculated onto sensitive cell cultures.

At total CPE, virus is harvested by centrifugation of cell culture supernatant at 2000 x g for 15 minutes, filter sterilised through 0,45 im membrane filter and distributed in labelled cryotubes.

Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and no

ed Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.

FeLV recombinant canarypox virus (vCP97)................................................................ ≥ 107.2 CCID501 1: cell culture infective dose 50 % 2: egg infective dose 50 % For a full list of excipients, see section 6.1.

FeLV recombinant canarypox virus (vCP97)................................................................ ≥ 107.2 CCID501 1: cell culture infective dose 50 % 2: egg infective dose 50 %

"micro-organism" shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture;

In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.

HIV-1 clinical isolates resistant to nucleoside analogue reverse transcriptase inhibitors (NRTI), non- nucleoside analogue reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI) and enfuvirtide

Agalsidase beta is a recombinant form of human α -galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture.

Active substance(s) FeLV recombinant Canarypox virus (vCP97)......... ≥ 10 7.2 CCID50 (cell culture infective dose 50 %) For a full list of excipients, see section 6.1.

*The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol ].

Remove cells from the collected supernatant by centrifugation (2000 to 4000 x g) or membrane filtration (0,45 μm) with a low protein binding membrane and dilute the supernatant 1:100 and 1:10000 in cell culture medium.

Following incubation at 37 °C for one hour to allow neutralisation to take place, 0,05 ml of suspension cells containing 0,5 to 1,0 × 106 cells per 1 ml in cell culture medium containing serum free of FMD antibody is added to each well and the plates are sealed.

The quantitative VN micro-test for swine vesicular disease virus antibody detection is performed with IB-RS-2 cells or an equivalent cell system in flat-bottomed tissue culture grade microtitre plates.

In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.

If this protocol gives negative results both with and without activation, an additional experiment without activation should be done, with continuous treatment until sampling at a time equivalent to about 1,5 normal cell cycle lengths.

Antiserum-treated organ suspension shall be inoculated into young actively growing cell cultures to give a final dilution of tissue material to culture medium of 1:1000 For each organ suspension 40 μl of inoculum shall be added to one well containing 2 ml of culture medium.

² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)

The manufacturing process for ReFacto has been modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name has been changed to ReFacto AF.

When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.

The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).

These other areas should be available for the preparation of glassware and media, the maintenance and preparation of non-infected cell cultures, the processing of sera and serological testing (other than methods using live ASF virus), and the provision of administrative and clerical support.

In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the Committee for Medicinal Products for Human Use (CHMP) for flu vaccines produced in cell culture.

At predetermined intervals after exposure of cell cultures to the test substance, they are treated with a metaphase arresting substance (e.g. Colcemid® or colchicine), harvested, stained and metaphase cells are analysed microscopically for the presence of chromosome aberrations.

Appropriate culture media, and incubation conditions (culture vessels, CO2 concentration, temperature and humidity) should be used in maintaining cultures, Established cell lines and strains should be checked routinely for stability in the modal chromosome number and the absence of mycoplasma contamination and should not be used if contaminated.

Resistance: the potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild type viral strains.

Intravenous pathogenicity indices of greater than 1.2 indicate the presence of virus requiring a full implementation of control measures (it would be a useful exercise if national Laboratories also carried out tests to determine the capacity of an isolate to produce plaques in cell cultures as specified in Chapter 8).

Antiviral activity in vitro Raltegravir at concentrations of 31 ± 20 nM resulted in 95 % inhibition (IC95) of HIV-1 replication (relative to an untreated virus-infected culture) in human T-lymphoid cell cultures infected with the cell-line adapted HIV-1 variant H9IIIB.

The simultaneous inoculation of a porcine cell line and one of the above-mentioned tissue culture systems (preferably primary bovine thyroid cells) is a useful guide as to whether vesicular samples contain swine vesicular disease virus or foot and mouth disease virus, as the former will only grow in cells of porcine origin.

pathogenic agents means any collection or culture of organisms or any derivative, present either alone or in the form of a manipulated combination of such a collection or culture of organisms capable of causing disease in any living being (other than man) and any modified derivatives of these organisms, which can carry or transmit an animal pathogen, or the tissue, cell culture, secretions or excreta by which or by means of which an animal pathogen can be carried or transmitted;

Antiviral activity: the free concentration of efavirenz required for 90 to 95 % inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.

The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation. *The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol ].

Since live measles vaccine and live mumps vaccine are produced in chick embryo cell culture, persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e. g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.