Abstract: The present invention relates to an analytical method for quantitation of selected multiple recombinant proteins in a complex matrix such as recombinant polyclonal antibodies in serum or recombinant polyclonal antibodies expressed in a culture supernatant.

Abstract: The present invention provides a structural characterization platform that can be used to assess the stability of a polyclonal cell line during production, as well as batch-to-batch consistency of the final polyclonal products. The structural characterization platform is based on genetic analyses as well as protein characterization techniques that alone or in combination provide the necessary information to characterize the polyclonal cell line and final products. The collection of different homologous proteins to be analyzed with the platform techniques if for example a recombinant polyclonal antibody or a mixture of monoclonal antibodies.

Abstract: The invention relates to a procedure for linking cognate pairs of VH and VL encoding sequences from a population of cells enriched in particular surface antigen markers. The linking procedure involves a multiplex molecular amplification procedure capable of linking nucleotide sequences of interest in connection with the amplification, in particular polymerase chain reaction (multiplex PCR). The method is particularly advantageous for the generation of cognate pair libraries as well as combinatorial libraries of variable region encoding sequences from immunoglobulins. The invention also relates to methods for generation of chimeric human/non-human antibodies and expression libraries generated by such methods.

Abstract: The invention relates to a method for manufacturing an anti-RhD recombinant polyclonal antibody composition (anti-RhD rpAb). The method comprises obtaining a collection of cells transfected with a library of anti-RhD antibody expression vectors, wherein each cell in the collection is capable of expressing from a VH and VL comprising nucleic acid segment, one member of the library, which encodes a distinct member of anti-RhD recombinant polyclonal antibody composition and which is located at the same site in the genome of individual cells in said collection. The cells are cultured under suitable conditions for expression of the recombinant polyclonal antibody, which is obtained from the cells or culture supernatant. The nucleic acid segments encoding the anti-RhD rpAb is introduced into the cells by transfection with a library of vectors for site-specific integration.

Abstract: The present invention relates to the field of compositions comprising anti-CD5 antibodies. In particular, the present invention concerns an antibody composition comprising at least two anti-CD5 antibodies capable of binding distinct CD5 epitopes. The invention further concerns bi-specific molecules having the binding specificities of said antibody compositions. The invention also relates topharmaceutical compositions, use of antibody compositions and methods for manufacturing antibody compositions. The invention further relates to cell banks and a method for killing cells.

Abstract: The invention relates to the field of recombinant antibodies for use in human cancer therapy. More specifically the invention provides the use of an antibody composition with two distinct non-overlapping binding specificities to human EGFR. The antibody composition is effecting in treating cancer following treatment with other anti-EGFR antibodies, whether the cancer shows progression during or following the prior treatment or not. The antibody composition can also be used for repeated treatment of recurrent tumours following first-line therapy with the antibody composition of the invention, as the composition does not lead to selection of resistant tumours. A further therapeutic use is the use of an antibody composition of the invention for treatment of cancer that is resistant to known anti-EGFR antibodies.

Abstract: A method for identifying and selecting chemical entities that contributes to a functional effect in the development of new combinatorial drugs. The combinations of two or more chemical compounds show a synergistic effect. The compounds can be e.g. antibodies, antibiotics, anti-cancer agents, anti-AIDS agents, anti-growth factors, antiviral agents, soluble receptors, cytokines, RNAi's, vaccines and mixtures thereof. The method comprises a) providing n samples each comprising a chemical entity, b) mixing 2 or more of the n samples in all possible combinations, c) subjecting this mixture to a functional assay in order to identify entities contributing to the functional effect. The steps a-c are repeated on the chemical entities from step c which contribute to the functional effect.

Abstract: The present invention relates to novel therapeutic antibodies directed against HER2 (ErbB2), as well as recombinant polyclonal anti-HER2 antibody compositions comprising at least two of said recombinant anti-HER2 antibodies, and use of the antibodies and antibody compositions for treatment of cancer.

Abstract: The present invention relates to treatment of thrombocytopenia with a pharmaceutical composition comprising re-combinant polyclonal anti-RhesusD antibody product as the active ingredient.

Abstract: Disclosed are novel polyclonal antibodies, which target respiratory syncytial virus (RSV), as well as novel high affinity antibody molecules reactive with RSV. The polyclonal antibodies may comprise antibody molecules which are reactive with both RSV protein F and RSV protein G, and preferably the polyclonal antibodies target a variety of epitopes on these proteins. The antibody molecules of the invention have shown superior efficacy in vitro and/or in vivo. Also disclosed are methods of producing the antibodies of the invention as well as methods of their use in treatment or prevention of RSV infection.

Abstract: Disclosed is an anti-orthopoxvirus recombinant polyclonal antibody comprising distinct members which in union are capable of binding at least three orthopoxvirus related antigens, a pharmaceutical composition comprising the antibody, and a method for its production. Also disclosed is a polyclonal cell line capable of producing the recombinant polyclonal antibody as therapeutic methods utilizing the polyclonal antibody. Finally, the invention also pertains to a method for screening for useful VH and VL pairs useful when preparing the polyclonal antibody.

Abstract: The invention relates to the field of recombinant antibodies for use in human cancer therapy. More specifically the invention provides compositions or mixtures of antibodies capable of binding human EGFR. Antibody compositions with 3 or more antibodies shown synergy in reduction of proliferation of representative cancer cell lines. Advantageous results have also been obtained with a composition comprising two different chimeric anti-hEGFR antibodies which show a new mechanism of action based on rapid and efficient receptor internalisation, induction of terminal differentiation and subsequent tumour eradication in an animal model. The antibodies of the invention can be manufactured in one bioreactor as a polyclonal antibody.

Abstract: The invention relates to the field of recombinant antibodies for use in human cancer therapy. More specifically the invention provides compositions or mixtures of antibodies capable of binding human EGFR. Antibody compositions with 3 or more antibodies shown synergy in reduction of proliferation of representative cancer cell lines. Advantageous results have also been obtained with a composition comprising two different chimeric anti-hEGFR antibodies which show a new mechanism of action based on rapid and efficient receptor internalisation, induction of terminal differentiation and subsequent tumour eradication in an animal model. The antibodies of the invention can be manufactured in one bioreactor as a polyclonal antibody.

Abstract: The invention relates to methods for manufacturing drug products comprising at least two distinct members of a polyclonal protein, for example a polyclonal antibody, where each distinct member is expressed by a separate population of cells. The methods involve at least an initial step in which the cell populations expressing the distinct members of the polyclonal protein are cultured separately. The individual cell populations, or proteins expressed by the individual cell populations, are combined at a later point of the upstream or downstream processing to result in a single drug product comprising the distinct members of the polyclonal protein.

Abstract: The invention relates to a method for manufacturing a recombinant polyclonal protein composition, in particular a recombinant polyclonal antibody composition. The method comprises obtaining a collection of cells transfected with a collection of variant nucleic acid sequences, wherein each cell in the collection is transfected with and capable of expressing one member of the collection, which encodes a distinct member of a polyclonal protein. The cells are cultured under suitable conditions for expression of the polyclonal protein, which is obtained from the cells or culture supernatant. The nucleic acid sequence is introduced into the cells by transfection with a collection of vectors. The present method is suitable for manufacturing recombinant polyclonal antibodies for therapeutic uses.

Abstract: The invention relates to the field of recombinant antibodies for use in human cancer therapy. More specifically the invention provides compositions or mixtures of antibodies capable of binding human EGFR. Antibody compositions with 3 or more antibodies showed synergy in reduction of proliferation of representative cancer cell lines. Advantageous results have also been obtained with a composition comprising two different chimeric anti-hEGFR antibodies which show a new mechanism of action based on rapid and efficient receptor internalisation, induction of terminal differentiation and subsequent tumour eradication in an animal model. The antibodies of the invention can be manufactured in one bioreactor as a polyclonal antibody.

Abstract: Disclosed are novel polyclonal antibodies, which target respiratory syncytial virus (RSV), as well as novel high affinity antibody molecules reactive with RSV. The polyclonal antibodies may comprise antibody molecules which are reactive with both RSV protein F and RSV protein G, and preferably the polyclonal antibodies target a variety of epitopes on these proteins. The antibody molecules of the invention have shown superior efficacy in vitro and/or in vivo. Also disclosed are methods of producing the antibodies of the invention as well as methods of their use in treatment or prevention of RSV infection.

Abstract: Disclosed is an anti-orthopoxvirus recombinant polyclonal antibody comprising distinct members which in union are capable of binding at least three orthopoxvirus related antigens, a pharmaceutical composition comprising the antibody, and a method for its production. Also disclosed is a polyclonal cell line capable of producing the recombinant polyclonal antibody as therapeutic methods utilizing the polyclonal antibody. Finally, the invention also pertains to a method for screening for useful VH and VL pairs useful when preparing the polyclonal antibody.

Abstract: Multiplex overlap-extension RT-PCR provides an efficient method of linking two or more nucleotide sequences encoding for domains or subunits of a heteromeric protein, in a single reaction. Especially, the linkage of variable region encoding sequences from e.g. immunoglobulins, T cell receptors or B cell receptors is eased with the method of the present invention. This allows for a more efficient way of generating libraries of variable region encoding sequences. The capability to perform the multiplex overlap-extension RT-PCR using template derived from an isolated single cell enables the generation of cognate pair libraries in a high-throughput format.

Abstract: Multiplex overlap-extension RT-PCR provides an efficient method of linking two or more nucleotide sequences encoding for domains or subunits of a heteromeric protein, in a single reaction. Especially, the linkage of variable region encoding sequences from e.g. immunoglobulins, T cell receptors or B cell receptors is eased with the method of the present invention. This allows for a more efficient way of generating libraries of variable region encoding sequences. The capability to perform the multiplex overlap-extension RT-PCR using template derived from an isolated single cell enables the generation of cognate pair libraries in a high-throughput format.