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The Ibc Pharmaceuticals, Inc. patent solves the following problem:
The effectiveness of a therapeutic agent may be enhanced by improving its bioavailability in some ways, one of which is the PEGylation, a process of chemically linking polyethylene glycol (PEG) to therapeutic agents of interest, with the conjugate results showed an increased serum half-life. Additional advantages of pegylated products that also include low immunogenicity, reduced dosing frequency, increased solubility, enhanced durability, and reduced renal clearance. Because the most common reactive sites on the protein (including peptide) for attaching PEG is the amino groups of lysine and the amino group of the A-terminal residue, the first method of PEGylation resulted in changes many places, yielding not only monoPEGylated conjugates consisting of mixtures of isomers seats, as PEGINTRON (Grace et al, J. Biol Chem 2005; 280: 6327) and PEGASYS (Dhalluin et al, Bioconjugate Chem 2005; 16: 504), but also adducts containing more than one PEG chain. Site-specific attachment of a PEG amino group of A-terminal residue reported that the predominant reaction products PEG-aldehyde (PEG-ALD) to lower pH of the IFN-1b (Basu et al., Bioconjugate Chem. 2006, 17: 618) or IFN-1a (Pepinsky et al, J. Pharmacol exp Father 2001; 297: …. 1059). Similar methods were applied in preparing N-ill relative PEG to G-CSF (Kinstler et al, Pharm Res 1996; 13: 996) or the soluble tumor necrosis things receptor (Kerwin et al Protein Sci 2002; 11: 1825). More recently, a strong-phase process for PEGylation A-terminus artificial interferon alpha-2a reported (Lee et al., Bioconjug. Chem. Oct. 18, 2007, ePub).
Our analysis of this patent is as follows:
Ibc Pharmaceuticals, Inc.’s patent US 9457100 B2 deals with PEGylation by the dock and lock (DNL) technique.
The present invention concerns methods and compositions for forming pegylated complexes of defined stoichiometry and structure. In preferred embodiments, the pegylated complex formed using dock-and-lock technology, by attaching a target agent to a DDD file and pasting a PEG moiety to an AD and authority DDD sequence to bind to AD in a 2: 1 stoichiometry, to form pegylated complexes with two target agents and one PEG moiety. In alternative embodiments, the target agent can be included in the AD and the PEG to the DDD to form pegylated complexes with two PEG moieties and one target agent. In more preferred embodiments, the target agent may comprise any peptide or protein of physiologic or therapeutic activities. The pegylated complexes exhibit a significantly slower rate of clearance when injected into a subject and the use for the treatment of a wide variety of diseases.
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