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Last Updated: December 6, 2021

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Patent: 9,868,973

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Summary for Patent: 9,868,973
Title:Method for optimizing post-translational modifications on recombinant proteins
Abstract: A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.
Inventor(s): Leszcyniecka; Magdalena (Cambridge, MA), Shulga-Morskoy; Sergey (Cambridge, MA)
Assignee: STC Biologics, Inc. (Cambridge, MA)
Application Number:15/111,260
Patent Claims:see list of patent claims

Details for Patent 9,868,973

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 1998-09-25 ⤷  Free Forever Trial 2039-02-26
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 2017-02-10 ⤷  Free Forever Trial 2039-02-26
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 2019-02-28 ⤷  Free Forever Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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McKinsey
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