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.
According to GlobalData’s company profile on Catalent, was a key innovation area identified from patents. Catalent's grant share as of June 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.
Activated formylglycine-generating enzymes for protein production
The patent US12018308B2 outlines a method for producing proteins that incorporate a formylglycine residue through the action of a formylglycine-generating enzyme (FGE) in a cell-free reaction environment. The process involves expressing both the FGE and a protein containing an FGE recognition site in the presence of Cu2+, which activates the FGE. This activation facilitates the conversion of specific amino acid residues (cysteine or serine) in the recognition site to formylglycine. The resulting protein can then be conjugated with an agent via the aldehyde moiety of the formylglycine residue. The agents can be therapeutic, including various classes such as cytotoxic, antiproliferative, antineoplastic, antibiotic, antifungal, and antiviral agents, or they can serve as imaging agents, which encompass a wide range of technologies including fluorescent dyes and various imaging modalities like MRI and PET.
Further claims detail the conditions and components of the reaction mixture, such as the inclusion of a reducing agent like 2-mercaptoethanol to enhance the conversion process. 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. The proteins targeted for modification include antibodies, antibody fragments, ligands, enzymes, and antigens, with particular emphasis on antibodies that bind to tumor-associated or tumor-specific antigens. This method presents a versatile approach for the development of modified proteins with potential applications in therapeutics and diagnostics.
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