US 9663810

Patent Overview: US9663810B2 — "Methods of Cell Culture"

Bibliographic data (as supplied): US Patent US9663810B2; application US14/941,984, filed 2015-11-16; granted/publication date 2017-05-30; priority date 2013-03-14; anticipated expiration 2033-03-14; legal status "Active." Inventor: Holly Prentice. Original assignee: Momenta Pharmaceuticals, Inc.; current assignee listed as Janssen Biotech Inc. The record also lists US20160068881A1 as an other version. Source: https://patents.google.com/patent/[US9663810](/patent/US9663810)/en

Purpose: The invention "relates generally to cell culture methods" for producing therapeutic polypeptides, particularly therapeutic antibodies. It addresses controlling the glycosylation profile of a recombinant protein by adding putrescine to culture medium.

Plain-language scope: The disclosed method produces a recombinant protein preparation having a target level of one or more "mature glycans." Steps recited: (a) provide a cell genetically engineered to express a recombinant protein; (b) culture it in medium comprising (e.g., supplemented with) putrescine, such that the cell expresses the protein; (c) harvest (purify/isolate from the cell and/or medium) a preparation of the protein; and (d) measure a level of one or more mature glycans, where the preparation has the target value. Putrescine is present "for a time and in an amount effective to modify (e.g., increase or decrease)" the mature glycans. Embodiments recite putrescine amounts ranging from about 0.01 mg/L to 40 mg/L or more, and ranges such as about 0.1–10 mg/L. The "target value" may be a level in a reference therapeutic product (a list of named products, e.g., infliximab, rituximab, trastuzumab, is provided), or a product specification/QC criterion, an FDA label, Physician's Insert, USP or EP monograph. One recited target: more than about 30% mature glycans (e.g., >40–95%) and/or less than about 90% high mannose, hybrid glycans, or their combination; the supplied excerpt is truncated at that point.

What the excerpt does not establish: It omits the full claims, complete specification, examples, figures, and any experimental data or working examples. It does not establish claim scope, allowability, enforcement, or the accuracy of the listed assignees, legal status, or dates. No findings on litigation, ownership transfers, validity, or prior art are made here.