EP-3583527-B1 - METHODS AND SYSTEMS FOR PROVIDING EPITOPE TAGGED BIOMOLECULES

EP3583527B1EP 3583527 B1EP3583527 B1EP 3583527B1EP-3583527-B1

Inventors

MARTIN, Jody
WRIGHT, ADAM
WATERMAN, PAUL
GHADIALI, James

Dates

Publication Date: 20260506
Application Date: 20180201

Claims (11)

A system for use in preparing an epitope tagged biomolecule reagent, the system comprising: an input manager for receiving a request for an epitope tagged biomolecule reagent, wherein the request for the epitope tagged biomolecule reagent comprises a biomolecule request and an epitope tag request; a memory comprising a first dataset comprising a plurality of biomolecule storage identifiers for a plurality of activated biomolecules and a second dataset comprising a plurality of epitope tag storage identifiers for a plurality of activated epitope tags; a processing module communicatively coupled to the memory and configured to identify one or more epitope tagged biomolecule storage identifiers from the first and second datasets that corresponds to the biomolecule request and the epitope tag request of the epitope tagged biomolecule reagent request; an output manager for providing the identified epitope tagged biomolecule storage identifiers; and a reagent preparatory apparatus for preparing the epitope tagged biomolecule reagent, wherein the reagent preparatory apparatus is operatively coupled to the output manager and is configured to: receive the identified biomolecule storage identifier and epitope tag storage identifier; and produce an epitope tagged biomolecule reagent corresponding to the received biomolecule storage identifier and the epitope tag storage identifier.
The system of claim 1, wherein the input manager is operatively coupled to a graphical user interface.
The system of any one of claims 1 to 2, wherein the input manager is configured to receive: a plurality of epitope tagged biomolecule requests; or a plurality of biomolecule requests and epitope tag requests.
The system of claim 3, wherein the input manager is configured to receive a plurality of biomolecule requests and epitope tag requests from a plurality of users.
The system of any one of claims 1 to 4, wherein the memory comprises an algorithm for providing a recommendation for: an alternative biomolecule when a biomolecule storage identifier that corresponds to the biomolecule request is not available; or an alternative epitope tag when an epitope tag storage identifier that corresponds to the epitope tag request is not available.
The system of any one of claims 1 to 5, wherein: the biomolecule is a compound selected from the group consisting of a polypeptide, a nucleic acid and a polysaccharide; and the epitope tag is polypeptide ranging in length from 1 to 100,000 amino acid residues.
The system of any one of claims 1 to 6, wherein the memory comprises: 25 or more biomolecule storage identifiers; and 10 or more epitope tag storage identifiers.
The system of any one of claims 1 to 7, wherein activated biomolecule and activated epitope tag each independently comprise a covalently coupled reactive linker.
A method comprising: communicating a request for an epitope tagged biomolecule reagent, the request comprising one or more of: an epitope tagged biomolecule request; and a biomolecule request and an epitope tag request; and receiving one or more epitope tagged biomolecule reagents, each epitope tagged biomolecule reagent comprising a biomolecule covalently coupled to an epitope tag through a linker or receiving a request for a epitope tagged biomolecule reagent, wherein the request for the epitope tagged biomolecule reagent comprises a biomolecule request and an epitope tag request, and receiving an epitope tagged biomolecule request by an input manager and storing a dataset in a memory comprising a plurality of epitope tagged biomolecule storage identifiers, by storing a first data set comprising a plurality of biomolecule storage identifiers for a plurality of activated biomolecules in memory and storing a second dataset comprising a plurality of epitope tag storage identifiers for a plurality of activated epitope tags in memory, wherein the method further comprises: preparing an epitope tagged biomolecule reagent corresponding to the epitope tagged biomolecule reagent request by contacting an activated biomolecule with an activated epitope tag to produce the epitope tagged biomolecule reagent, wherein the preparing comprising selecting an activated biomolecule and an activated epitope tag from a storage comprising a plurality of activated biomolecules and a plurality of activated epitope tags, and particularly identifying the epitope tagged biomolecule storage identifier that corresponds with the epitope tagged biomolecule reagent request; and outputting the identified epitope tagged biomolecule reagent storage identifier.
The system according to claim 1 further comprising: a plurality of activated biomolecules; and a plurality of activated epitope tags.
The system of claim 6, wherein the biomolecule is an antibody or binding fragment thereof.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to United States Provisional Patent Application Serial No. 62/459,941 filed February 16, 2017. INTRODUCTION Assays for determining the presence and concentration of analytes in a biological fluid often rely on the specific binding of a probe compound. Depending on the analyte of interest, the probe compound may be a polypeptide, such as an antibody or binding fragment thereof, having a specific binding region. Assays that employ antibody or antibody derived probe compounds are often referred to as immunoassays. Immunoassays can be configured as direct or indirect immunoassays. As illustrated in FIG. 1A, in direct immunoassays, the antibody specific reagent also includes a detectable label, such as a fluorophore. In contrast to direct immunoassays, indirect immunoassays employ sets of two or three immuno-reagents, which sets include a first target specific immuno-reagent and at least one additional anti-species specific immuno-reagent that binds to the target specific immuno-reagent, where at least one of the additional anti-species specific immuno-reagents is labeled, e.g., with a direct or indirectly detectable label. FIG. 1B provides an illustration of an indirect immunoassay. The purpose for these two or three immuno-reagent formats is two two-fold: 1) to associate a detectable label with the target analyte and to amplify any signal.1 SUMMARY OF THE INVENTION The invention is defined in the appended claims. SUMMARY OF RELATED DISCLOSURE Aspects of the present disclosure include systems for use in preparing an epitope tagged biomolecule reagent. Systems according to certain embodiments include an input manager for receiving a request for an epitope tagged biomolecule reagent, a memory for storing a dataset having a plurality of epitope tagged biomolecule reagent storage identifiers, a processing module communicatively coupled to the memory and 1 FIGS. 1A and 1B taken from http://www.abcam.com/secondary-antibodies/direct-vs-indirect-immunofluorescence configured to identify one or more epitope tagged biomolecule reagent storage identifiers from the dataset that corresponds to the epitope tagged biomolecule reagent request and an output manager for providing the one or more identified epitope tagged biomolecule reagent storage identifiers. A reagent preparatory apparatus for preparing the epitope tagged biomolecule reagent from an activated biomolecule and activated epitope tag is also described. Methods for communicating and receiving an epitope tagged biomolecule reagent request and preparing the subject epitope tagged biomolecule reagents are also provided. Aspects of the invention include a fast, efficient and highly scalable process for delivering high quality and performance specific products across a wide range of biomolecule and epitope portfolios. In embodiments of the invention, a request for an epitope tagged biomolecule is made and in response to the request the epitope tagged biomolecule is prepared from a pre-existing collection of activated biomolecules and activated epitope tags. Figure 2 provides an illustration of a method according to an embodiment of the invention. In Figure 2, a collection of biomolecules (201a) and collection of epitope tags (201b) are first purified. (Step 201) Each biomolecule is then conjugated to a reactive linker to functionalize the biomolecules with a reactive moiety (i.e., activate the biomolecules with reactive linker L1, 202a). The collection of activated biomolecules is then purified and stored. Separately, a collection of epitope tags is also conjugated to reactive linkers to functionalize the collection of epitope tags with a reactive moiety (i.e., activate the epitopes with reactive linker L2, 202b). The collection of activated epitope tags is also purified and stored (Step 202). Upon request of an epitope tagged biomolecule reagent from a customer, a biomolecule is conjugated to an epitope tag by reacting an activated biomolecule (L1) with an activated epitope tag (L2) (Step 203) to form epitope tagged biomolecule (bonded through linkage L1-L2). In this way, any desired combination of biomolecule and epitope tag can be prepared on-demand by simply mixing an activated biomolecule with an activated epitope tag. Figure 3 illustrates this unique and new method of the present disclosure for providing customizable epitope tagged biomolecule reagents on-demand. A biomolecule of interest is purified (step 301) and then functionalized with a reactive linker (step 302) to produce an activated biomolecule 300a. Activated epitope tags 300b, 300c and 300d are separately prepared by functionalizing epitope tags with reactive linkers. Upon receipt of a request from a customer, any combination of activated biomolecule 300a and activated epitope tags 300b, 300c, 300d and 300e can be prepared on-demand by reaction of the reactive linker of activated biomolecule 300a with the reactive linkers of activ