Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.

2 3 adsorbed on aluminium phosphate Total: 0.40 milligrams Al3+ produced in Saccharomyces cerevisae cells by recombinant DNA technology rod

FeLV recombinant Canarypox virus (vCP97)......... ≥ 10 7.2 CCID50 (cell culture infective dose 50 %)

Mammalian cell-transformation assays are available which measure the ability of a substance to induce morphological and behavioural changes in cell cultures, which are thought to be associated with malignant transformation - in vivo, (Method B.21).

Sera for the test are diluted 1/4 in serum-free cell culture medium with the addition of 100 IU/ml neomycin or other suitable antibiotics.

Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4 Adsorbed on aluminium phosphate

Optaflu suspension for injection in a pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Cell culture medium shall be removed from each well, including those of positive and negative controls, and placed in labelled sterile tubes.

Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

type and number of aberrations given separately for each treated and control culture, modal number of chromosomes in established cell lines used;

produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3 4

Cytotoxic activity in cell cultures Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human tumour cells.

From each virus-serum mixture (prepared as laid down in Part II.B.II.3) at least two cell cultures per cell line are inoculated with 50 μl each.

for viruses and viroids test for infectivity carried out by bio assay or on a suitable cell culture at least seven days after administration to test animals

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of a reference strain of bluetongue virus.

An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.

FeLV recombinant canarypox virus (vCP97)................................................................  10 7.2 CCID 50 1 1: cell culture infective dose 50 % For a full list of excipients, see section 6.1.

FeLV recombinant canarypox virus (vCP97).................................................................  107.2 CCID 50 1 1: cell culture infective dose 50 %

Research in animals and in cell culture has suggested that many active substances could influence the effects of PDT, possible examples of which are described below.

Data as outlined under point 5.1.2 and tests for infectivity carried out by bio-assay or on a suitable cell culture at least seven days after the last administration to the test animals

Epoetin alfa did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.

Laronidase is a recombinant form of human α -L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).

Stock FMDV antigen is prepared in cell cultures or on cattle tongues and stored at -70 °C or less or at -20 °C after the addition of 50 % glycerol.

Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2007/ 2008 season)

Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.

Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.

Resistance is mediated by reduced inhibitor binding to the altered HBV reverse transcriptase, and resistant HBV exhibits reduced replication capacity in cell culture.

Data as outlined under point 5.1.1 and cell culture studies using purified infective virus and primary cell cultures of mammalian, avian and fish cells

Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation.

Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.

i(ii) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings;

i(v) either an immunofluorescent antibody test or a culture test for campylobacter foetus infection on a sample of preputial material or artificial vaginal washings;

Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.

1 vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody manufactured from a mammalian cell line (Chinese hamster ovary, CHO) by continuous perfusion.

produced in Saccharomyces cerevisae cells by recombinant DNA technology lon For excipients, see section 6.1.

However, where such samples are not available or not suitable for transport, animal passage material, obtained from the same host species, or low passage cell culture material is acceptable.

In cell culture, entecavir selected for an M184I substitution at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations.

HBV encoding the adefovir resistance-associated substitutions rtN236T or rtA181V had 0.5- and 3.7-fold change in susceptibility to telbivudine in cell culture, respectively (see section 4.4).

Live attenuated Aujeszky’ s Disease Virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion. * CCID50 = the quantity of virus, which infects 50 % of the cell cultures inoculated.

The pools are then inoculated into homologous cell cultures undiluted and diluted 1:10 (resulting in final dilutions of 1:10 and 1:100, respectively, of the supernatant) as described in Part I.III2.

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.

ADVATE is prepared without the addition of any human - or animal-derived protein in the cell culture process, pur ification or final formulation.

When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique.

Analytical methods for amount or activity of proteinaceous products should also be included, e.g. by testing exponential cultures and culture supernatants in an animal cell bioassay.

ADVATE is prepared without the addition of any human- or animal-derived protein in the cell culture process, purification or final formulation.

Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.

Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. t

Other cells or cell lines may be successfully used with the same test protocol, if the culture conditions are adapted to the specific needs of the cells, but equivalency must be demonstrated.