The present invention concerns methods for selecting and producing idiotype vaccines, and in particular methods for selecting and producing an idiotype vaccine for treatment of a B-cell derived malignancy in a subject based on the clonal profile (clonotype) of the malignancy; a method for producing an updated idiotype vaccine matched to a B-cell derived malignancy exhibiting a shifting clonal profile; and the high- fidelity idiotype vaccines produced using the methods. The invention also includes idiotype vaccines produced using the described methods and methods of treating B-cell derived malignancies using the produced vaccines.
C12Q 1/68 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismes; Compositions à cet effet; Procédés pour préparer ces compositions faisant intervenir des acides nucléiques
A61K 48/00 - Préparations médicinales contenant du matériel génétique qui est introduit dans des cellules du corps vivant pour traiter des maladies génétiques; Thérapie génique
2.
BIOMANUFACTURING SUITE AND METHODS FOR LARGE-SCALE PRODUCTION OF CELLS, VIRUSES, AND BIOMOLECULES
The present invention provides a production module for large-scale production of cells and/or cell-derived products such as antibodies or virus; a production suite comprising a plurality of functionally connected production modules of the invention; and a method for large-scale production of cells and/or cell-derived products using the production modules and/or production suites of the invention.
THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY ,DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)
Inventeur(s)
Wilson, Wyndham, H.
Santos, Carlos
Kwak, Larry, W.
Neelapu, Sattva, S.
Abrégé
The present invention relates to methods of treating cancer with a cancer vaccine using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a biomarker; methods of prognosticating an outcome of cancer treatment with a cancer vaccine using GM-CSF as a biomarker; methods for qualifying subjects for cancer vaccination using GM-CSF as a biomarker; methods for comparing the efficacy of two or more cancer vaccine treatments based on GM-CSF response; and kits for the effective treatment of cancer.
A61K 47/48 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p.ex. supports, additifs inertes l'ingrédient non actif étant chimiquement lié à l'ingrédient actif, p.ex. conjugués polymère-médicament
The invention concerns a bioreactor for production of virus and virus-like particles (VLPs), methods for production of virus and VLPs, methods for regulating the concentration of molecules inhibitory to viral and VLP yield in a cell culture chamber of a bioreactor, such as the extracapillary space of a hollow fiber bioreactor.
C12N 7/00 - Virus, p.ex. bactériophages; Compositions les contenant; Leur préparation ou purification
C12M 3/02 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus comportant des moyens fournissant des suspensions
5.
METHOD AND APPARATUS FOR ANTIBODY PRODUCTION AND PURIFICATION
The subject invention pertains to methods and apparatus for the production and purification of cell products, such as immunoglobulins. One aspect of the invention is an integrated cell culture and purification apparatus for the growth and maintenance of cells and the harvest and purification of cell products, such as immunoglobulins. Thus, the apparatus integrates a cell culture function with a purification function. Other aspects of the invention pertain to an automated method for producing immunogenic compositions such as vaccines.
C12M 3/02 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus comportant des moyens fournissant des suspensions
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
C07K 1/16 - Extraction; Séparation; Purification par chromatographie
C07K 16/30 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire provenant de cellules de tumeurs
6.
MATERIALS AND METHODS FOR DIRECTING AN IMMUNE RESPONSE TO AN EPITOPE
The present invention relates to compositions, kits, and methods useful for directing an immune response to an epitope of an antigen in a subject, by sensitizing the subject to the epitope and/or by tolerizing the subject to the epitope. The sensitizing method comprises co-administering to the subject the epitope and an immunoglobulin M (IgM) constant region (IgM Fc region). The tolerizing method comprises co-administering to the subject the epitope and an immunoglobulin G (IgG) constant region (IgG Fc region) to the subject.
C07K 16/28 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
C07K 16/18 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains
C07K 16/24 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
G01N 33/574 - Tests immunologiques; Tests faisant intervenir la formation de liaisons biospécifiques; Matériaux à cet effet pour le cancer
7.
MATERIALS AND METHODS FOR DESIGNING AUTOLOGOUS IDIOTYPE VACCINES AND TREATMENT OF B-CELL MALIGNANCIES
The present invention relates to compositions, kits, and methods for preparing an autologous idiotypc vaccine, or autologous anti-idiotype vaccine, for treatment of a B-cell malignancy based on the isotype(s) (class(es)) of immunoglobulins expressed by the malignancy; methods for treating B-cell malignancies; and methods for selecting a treatment for a subject having a B-cell malignancy.
A61K 38/39 - Peptides du tissu connectif, p.ex. collagène, élastine, laminine, fibronectine, vitronectine, globuline insoluble à froid [CIG]
C07K 16/24 - Immunoglobulines, p.ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des cytokines, des lymphokines ou des interférons
C12M 3/02 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus comportant des moyens fournissant des suspensions
C12M 1/04 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens d'introduction de gaz
9.
METHODS FOR INDUCING A SUSTAINED IMMUNE RESPONSE AGAINTS A B-CELL IDIOTYPE USING AUTOLOGOUS ANTI-IDIOTYPIC VACCINES
The present invention relates to methods of inducing and maintaining an immune response against a B-cell idiotype in a subject using an autologous anti-idiotypic vaccine. In one embodiment, the immune response is induced and maintained for treatment of a B-cell derived malignancy selected from among non-IIodgkin's lymphoma, HodgkiiTs lymphoma, chronic lymphocytic leukemia, multiple myeloma, and mantle cell lymphoma.
A61K 39/00 - Préparations médicinales contenant des antigènes ou des anticorps
A61P 37/00 - Médicaments pour le traitement des troubles immunologiques ou allergiques
A61K 39/39 - Préparations médicinales contenant des antigènes ou des anticorps caractérisées par les additifs immunostimulants, p.ex. par les adjuvants chimiques
A cell culture system for the production of cells and cell derived products includes a reusable instrumentation base device incorporating hardware to support cell culture growth. A disposable cultureware module including a cell growth chamber is removably attachable to the instrumentation base device. The base device includes microprocessor control and a pump for circulating cell culture medium through the cell growth chamber. The cultureware module is removably attached to the instrumentation base device. Cells are introduced into the cell growth chamber and a source of medium is fluidly attached to the cultureware module. Operating parameters are programmed into the microprocessor control. The pump is operated to circulate the medium through the cell growth chamber to grow cells or cell products therein. The grown cells or cell products are harvested from the cell growth chamber and the cultureware module is then disposed.
A cell culture system for the production of cells and cell derived products including a reusable instrumentation base device incorporating hardware to support cell culture growth. A cell cultureware module is removably attached to the instrumentation base device and includes a cell growth chamber. At least one rotary actuator valve is provided for controlling circulation of cell culture medium through at least one elastomer medium flow circuit in the cultureware module. The at least one rotary actuator valve includes a housing having an inner passage and at least one port for receiving the at least one elastomer medium flow circuit, and a valve body having first and second ends located within the inner passage of the valve housing and rotatable about a longitudinal axis within the valve housing. The valve body includes a plurality of cam surfaces and angular sections disposed along a length thereof to sequentially compress and open the elastomer medium flow circuit as the valve body rotates within the valve housing.
C12M 3/00 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus
F16K 7/06 - Dispositifs d'obturation à diaphragme, p.ex. dont un élément est déformé, sans être déplacé entièrement, pour fermer l'ouverture à diaphragme tubulaire dont l'étranglement est assuré par une force extérieure radiale par tige filetée, came ou autre moyen mécanique
12.
INTERFACE OF A CULTUREWARE MODULE IN A CELL CULTURE SYSTEM AND INSTALLATION METHOD THEREOF
A cell culture system for the production of cells and cell derived products and an interface system and method for removably connecting a disposable cell cultureware module to a reusable instrumentation base device incorporating mechanical and electrical hardware to support cell culture growth. The cultureware module includes a plurality of mechanical and electrical interfaces, such that when the cultureware module is positioned on the instrumentation base device the plurality of mechanical and electrical interfaces of the cultureware module mate with the mechanical and electrical hardware of the instrumentation base device.
An extra-capillary fluid cycling unit (40) for maintaining and cycling fluid volumes in a cell culture chamber includes a housing (50) and a first flexible extra-capillary fluid reservoir (42) disposed in the housing. The extra-capillary fluid reservoir is in fluid communication with a cell culture chamber. A second flexible reservoir (44) is also located in the housing, the second flexible reservoir being in fluid communication with a pressure source. A sensor plate (46) is movably disposed in the housing between the extra-capillary reservoir and the second reservoir, wherein the second reservoir is pressurized to move the sensor plate in relation to the extra-capillary reservoir to cause fluid cycling and maintain fluid volumes in the cell growth chamber.
C12M 1/12 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens de stérilisation, filtration ou dialyse
C12M 3/06 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus avec des moyens de filtration, d'ultrafiltration, d'osmose inverse ou de dialyse
F04B 43/08 - "Machines", pompes ou installations de pompage ayant des organes de travail flexibles ayant des organes flexibles tubulaires
14.
MEDIA CIRCULATION SYSTEM FOR A CELL CULTUREWARE MODULE
A media circulation system for a self-contained cell culture environment includes a multi-channel, variable output pump located in a reusable instrumentation base device having hardware to support cell culture growth. The pump circulates cell culture medium through a disposable cultureware module removably located on the instrumentation device. A pump cassette (20) having attached tubing is removably located on the disposable cultureware module, the pump cassette and tubing being insertable into the multi-channel pump.
brevets
