Catalent. has been granted a patent for methods to produce activated formylglycine-generating enzymes (FGE) and their application in generating proteins with formylglycine residues. The patent includes both cell-based and cell-free methods, along with related compositions and kits for practical use. GlobalData’s report on Catalent gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Catalent, was a key innovation area identified from patents. Catalent's grant share as of July 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents.
Activated formylglycine-generating enzymes for protein production
The granted patent US12018308B2 outlines a method for producing proteins that incorporate a formylglycine residue through the activation of a formylglycine-generating enzyme (FGE) in a cell-free reaction mixture containing Cu2+. The process involves expressing both the FGE and a protein with an FGE recognition site, allowing the activated enzyme to convert specific residues (cysteine or serine) in the protein to formylglycine. This modified protein can then be conjugated with an agent via the aldehyde moiety of the formylglycine residue. The agents can include therapeutic agents, such as cytotoxic, antiproliferative, antineoplastic, antibiotic, antifungal, and antiviral agents, or imaging agents, which may encompass a variety of imaging modalities including fluorescent dyes and various types of nuclear imaging agents.
Further claims detail the conditions and components of the reaction mixture, including the use of reducing agents like 2-mercaptoethanol to facilitate the conversion of residues. The source of Cu2+ can be various compounds, with copper sulfate being specifically mentioned. The patent also specifies that the FGE can be an N-terminally truncated variant, particularly a human FGE, and that the proteins targeted for modification can include antibodies, antibody fragments, ligands, and enzymes. Notably, antibodies may be designed to bind to tumor-associated or tumor-specific antigens, with a list of potential targets provided, such as HER2 and CD19. This method presents a versatile approach for enhancing the functionality of proteins for therapeutic and diagnostic applications.
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