Chemistry: molecular biology and microbiology – Apparatus – Including condition or time responsive control means
Reexamination Certificate
2001-08-27
2004-01-06
Redding, David A. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
Including condition or time responsive control means
C435S287300, C435S303100
Reexamination Certificate
active
06673595
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to the field of cell culture; and more particularly to an automated system for management of culturing cells and manipulating the cultured cells.
BACKGROUND OF THE INVENTION
Basic operations for culturing cells may include, but are not limited to, initiation of a cell culture, maintenance of cell culture (e.g., storage under appropriate environmental conditions, replacement with tissue culture medium to renew nutrient availability, when desired in promoting cell growth), harvesting (e.g., harvesting the cultured cells and/or cell culture medium, particularly when the culture medium contains a substance produced by the cultured cells), and termination of the cell culture. A cell culture may be manipulated by one or more means that may include, but is not limited to: changing the environmental conditions to which the cell culture is exposed; treating the cultured cells with a biological substance for either evaluating the effect of the substance on the cultured cells, or for inducing the cultured cells to respond in a morphological, physiological, biological, or biochemical manner; and evaluating cultured cells by detecting and/or measuring (“determining”) one or more cell culture parameters which comprises one or more parameters of cultured cells and/or one or more parameters of the cell culture medium. As known to those skilled in the art, a parameter of cultured cells may include, but is not limited to, growth rate, morphology (e.g., size, shape, and the like), state of differentiation, granularity, migration, light scatter, attachment (anchorage-dependency or lack thereof), and the like. A parameter of the cell culture medium may comprise a chemical, biological, or physical characteristic of the medium (including, but not limited to, pH, oxygen content, CO
2
content, nutrient content (e.g., glucose), and the like); or the presence of a product of cultured cells which is secreted, excreted, or released into the cell culture medium (including, but not limited to, metabolite, cytokine, recombinant product (e.g., protein, peptide, and the like), and the like). In culturing and manipulating cells, performed is a sequence of dissociated operations, wherein the sequence may be varied depending on the desired objective.
Genomics, proteomics, and drug discovery are generating a need for expanded versatility of applications for manipulating cell cultures, as well as a greater need for efficient and economical growth of cultured cells in high volume (“high-throughput cell culture”). For example, in developing and testing one or more biological substances (e.g., including, but not limited to, genetic vectors, genetic sequences, vaccines, drugs, growth factors, cytokines, chemicals, enzymes, or the like), it may often be desirable to evaluate the response of cultured cells after treatment with a biological substance; and additionally to evaluate the responses in a multitude of treated cell cultures being grown simultaneously. It is known in the art (see, e.g.,
Genetic Engineering News
20:26, Sep. 1, 2000) that while a large cell culture lab may be able to handle simultaneously a few dozen cell cultures, the present systems are not adequate to meet industry's current demands for high-throughput cell culture. Despite advances in bioautomation technology, a bottleneck in implementing high-throughput cell culture is a lack of automated systems which maximize the number of cell cultures that can be grown and manipulated simultaneously. Thus, not only is there a need for an automated system for carrying out basic operations for culturing cells, there is also a need for an automated system for manipulating cultured cells (e.g., treating cultured cells with one or more biological substances, and may further include evaluating cultured cells for one or more cell culture parameters). Such an automated system would be capable of, as an integrated unit, performing dissociated operations associated with culturing cells and with manipulating cultured cells.
Conventional cell culture devices and manual methods for culture are not adequate for high-throughput cell culture. In a manual method of culturing cells, a cell culture device containing cultured cells is removed from a controlled environment (e.g., that maintains a specific atmosphere, temperature, and humidity) provided by a conventional tissue culture incubator. Thus, once removed from this controlled environment, the cultured cells may be subject to a rapid change in the environment. Currently, to perform one or more operations of cell culturing (e.g., removal of cell culture medium, addition of fresh tissue culture medium, removal of cultured cells, addition of cells to be cultured, and the like), it is first necessary to open the cell culture device to allow for pipetting. In that regard, conventional cell culture devices, such as flasks and roller bottles, have screw caps which require temporary removal to allow for pipetting of one or more of tissue culture medium, cell culture medium, or cells into or out of the cell culture device. Thus, opening and closing a number of cell culture devices during routine culturing is highly labor intensive, and necessitates an open system, at least part of the time, which greatly increases a breach in the maintenance of sterility of the cultures. Further, in a harvesting operation which requires separation of substantially all of the cell culture medium from the cultured cells (e.g., in harvesting the cell culture medium and/or the cells), transfer of the cell culture to and from a vessel for centrifugation is required. This “harvesting” operation represents additional time in which the cells are removed from a controlled environment, and represents an additional risk in breaching the maintenance of sterility of the culture. Additionally, due to the relative inefficient gas transfer through the screw cap, a large volume of air space (relative to the growth surface) is required in conventional cell culture devices; and hence, their overall size is rather bulky. Therefore, a tissue culture incubator can accommodate only a relatively limited number of conventional cell culture devices simultaneously, in adding to the difficulty and expense of high-throughput cell culture.
Thus, there is a need for an automated system for performing basic operations for culturing cells, and which may be used for high-throughput cell culture.
SUMMARY OF THE INVENTION
The present invention provides an automated system for management of cell cultures (“an automated cell management system”). The terms “cell management” and “management of cell cultures” are used synonymously to mean that the automated system of the present invention can perform operations for culturing cells, and operations for manipulating cell cultures, as will be more apparent from the following descriptions. Thus, provided is an automated system for culturing cells, and manipulating cell cultures.
It is a primary object of the invention to provide an automated system that may be used for high-throughput cell culture.
It is another object of the present invention to provide an automated cell management system capable of integrating into one unit the capability to perform dissociated operations of cell culturing and cell culture manipulation.
It is another object of the present invention to provide an automated cell management system that can be programmed to perform and control various operations of cell culturing and cell culture manipulation.
Briefly, the automated cell management system according to the present invention comprises an apparatus comprising: a mechanism for incubating cells comprising an housing having a chamber used to provide controlled environmental conditions in which cells may be cultured and manipulated (such chamber may also be referred to as a “biochamber”); a storage array (rack system) for accommodating a plurality of cell culture devices, wherein a cell culture device comprises a housing (preferably a frame) to which is secured (by a leak-proof sealing) at least
Benesch Friedlander Coplan & Aronoff LLP
Biocrystal LTD
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