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System and method for determining deamidation and immunogenicity of polypeptides

A technology of deamidation and correlation analysis, applied in chemical instruments and methods, specific peptides, immunoglobulins, etc., can solve complex and time-consuming problems, and achieve the effect of enhancing the signal-to-noise ratio

Pending Publication Date: 2021-07-30
PROTEIN DYNAMIC SOLUTIONS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This is a complex and time-consuming process

Method used

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  • System and method for determining deamidation and immunogenicity of polypeptides
  • System and method for determining deamidation and immunogenicity of polypeptides
  • System and method for determining deamidation and immunogenicity of polypeptides

Examples

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Embodiment 1

[0164] 1 μg / μL of PDS NIST mAb, 1 μg / μL of NIST mAb, and 1.5 μg / μL of NIST mAb candidates at 1780-1450cm -1 A comparative 2D IR correlation spectroscopy analysis was performed within the spectral region. For each of the three studied sample proteins, a temperature range of 1780-1450 cm corresponding to the temperature range of 28-56 °C was generated -1 Overlay of QCL IR spectra for the amide I and amide II bands in the spectral region. From these spectral overlay plots, 2D IR correlation was used to generate synchronous and asynchronous plots corresponding to the temperature range of 28-56 °C. Figure 6A Shown at 1780-1450cm -1 Overlay of QCL spectra for the amide I and amide II bands corresponding to the temperature range of 28-56 °C for PDSNIST mAb samples in the spectral region of . Figure 6B shows the synchronization diagram, and Figure 6C shows based on Figure 6A Asynchronous plots generated from QCL spectral overlay data shown. Figure 7A Shown at 1780-1450cm ...

Embodiment 2

[0170] 2 μg / μL of PDS NIST mAb (RM 8671 ), 2 μg / μL of PDS NIST mAb (RM 8671 ) in 12.5 mM L-histidine at pH 6.0 under heat stress in the temperature range of 28-56° C. using the methods and systems described herein. NIST mAb (RM 8671) and 2.4 μg / μL NIST mAb candidate (RM 8670) at 1780-1450 cm -1 A comparative 2D IR correlation spectroscopy analysis was performed within the spectral region. For each of the three studied sample proteins, a temperature range of 1780-1450 cm corresponding to the temperature range of 28-56 °C was generated -1 Overlay of QCL IR spectra for the amide I and amide II bands in the spectral region. From these spectral overlay plots, 2D IR correlation was used to generate synchronous and asynchronous plots corresponding to the temperature range of 28-56 °C. Figure 10A Shown at 1780-1450cm -1 QCL spectral overlay of the amide I and amide II bands corresponding to the temperature range of 28-56 °C for the PDS NIST mAb samples in the spectral region of . ...

Embodiment 3

[0175] 2.8 μg / μL of NIST mAb (RM 8671 ) and 10 μg / μL of NIST mAb (RM 8671 ) in 12.5 mM L-histidine at pH 6.0 under heat stress in the temperature range of 28-56° C. were tested using the methods and systems described herein. NIST mAb candidate (RM8670) at 1780-1450cm -1 A comparative 2D IR correlation spectroscopy analysis was performed within the spectral region. For the NIST mAb (RM8671) at 2.8 μg / μL and the NIST mAb candidate (RM 8670) at 10 μg / μL, 1780-1450 cm -1 Overlay of QCL IR spectra for the amide I and amide II bands in the spectral region. From these spectral overlay plots, 2D IR correlation was used to generate synchronous and asynchronous plots corresponding to the temperature range of 28-56 °C. Figure 14A Shown at 1780-1450cm -1 Overlay of the QCL spectra of the amide I and amide II bands corresponding to the temperature range of 28-56 °C for the NIST mAb samples in the spectral region of . Figure 14B shows the synchronization diagram, and Figure 14C show...

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Abstract

Characteristics of proteins, peptides, and / or peptoids can be determined via two-dimensional correlation spectroscopy and / or two-dimensional co-distribution spectroscopies. Spectral data of the proteins, peptides, and / or peptoids can be obtained with respect to an applied stress, such as thermal stress. Two-dimensional correlation spectroscopy can be used to generate two-dimensional synchronous and asynchronous plots. The asynchronous plot provides enhanced resolution and the sequential order of molecular events that occur as a function of the applied stress. Peaks may be identified in the asynchronous plot, and correlation of peaks that exhibit out-of-phase intensity changes can be used to determine the existence and extent of deamidation events.

Description

[0001] related application [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 750,022, filed October 24, 2018, the entire contents of which are hereby incorporated by reference. Background technique [0003] The high attrition rate of drug candidates such as protein therapeutics is a major cost driver in drug development and remains a major challenge for the biopharmaceutical industry. Immunogenicity, protein aggregation, deamidation, and oxidation are of concern to regulatory agencies because of their potential impact on reduced drug efficacy and patient safety. Proteins are complex molecules and under different conditions non-enzymatic deamidation of asparagine to aspartate or glutamine to glutamate may occur. The appearance of isomeric products was only observed at high pH conditions. Specifically, the deamidation process in proteins is associated with low and high pH conditions and thermal stress. Thus, risks that occur include: (1) ups...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16B40/00
CPCC07K16/00C07K2317/94G16B15/20G16B40/10G16B40/20G16B15/00
Inventor B·帕斯特拉纳-里奥斯野田勇夫
Owner PROTEIN DYNAMIC SOLUTIONS LLC
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