公开(公告)号：WO2022061092A1

公开(公告)日：2022-03-24

申请号：PCT/US2021/050842

申请日：2021-09-17

Applicant: AMGEN INC.

Inventor： XIAO, Gang ,  BONDARENKO, Pavel ,  SHI, Liuqing ,  DILLON, Thomas M. ,  REN, Da ,  RICCI, Margaret Speed ,  CUI, Weidong ,  HARRAHY, John Joseph ,  PAWLOWSKI, Jake ,  DYKSTRA, Andrew ,  RIGGS, Dylan

IPC: C07K14/435 ,  C12N9/76 ,  G01N33/68

Abstract: Provided herein are methods of processing a polypeptide or protein for analysis, e.g., peptide mapping analysis by mass spectrometry. In exemplary embodiments, the method comprises incubating a digested sample at a mildly acidic pH and/or in the presence of a chaotrope, wherein the digested sample is produced by digesting a polypeptide with a protease to produce a digested sample comprising at least two peptides. In exemplary embodiments, the method comprises digesting the polypeptide with a protease which cleaves C-terminal to tryptophan to produce a digested sample comprising at least two peptides. In exemplary embodiments, the method comprises digesting the polypeptide with trypsin at an enzyme:substrate (E:S) weight ratio of about 1:1 to about 1:15 to produce a digested sample comprising at least two peptides. In exemplary aspects, the digested sample comprises at least one or two peptides each comprising a tyrosine at the C-terminus.

公开(公告)号：WO2007014073A3

公开(公告)日：2007-02-01

申请号：PCT/US2006/028476

申请日：2006-07-20

Applicant: AMGEN INC. ,  KRISHNAN, Sampathkumar ,  PALLITTO, Monica ,  NAGLE, Samantha ,  CRAMPTON, Shon Lee ,  RICCI, Margaret Speed ,  CAO, Wenjin ,  LIN, Hong ,  XIE, Yong

Inventor： KRISHNAN, Sampathkumar ,  PALLITTO, Monica ,  NAGLE, Samantha ,  CRAMPTON, Shon Lee ,  RICCI, Margaret Speed ,  CAO, Wenjin ,  LIN, Hong ,  XIE, Yong

IPC: A61K39/395 ,  A61K9/19 ,  C07K16/46

Abstract: The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.