SPECTROSCOPIC ANALYSIS OF NUTRIENT MATERIALS FOR USE IN A CELL CULTURE PROCESS

• US 20140185033A1
• Filed: 12/11/2013
• Published: 07/03/2014
• Est. Priority Date: 12/11/2012
• Status: Active Grant

• Current Assignee: Biogen MA Inc. (Biogen, Inc.)
• Original Assignee: Biogen Idec MA Inc. (Biogen, Inc.)
• Inventors: Moretto, Justin
• Granted Patent: US 9,506,867 B2
• Time in Patent Office: Days
• US Class Current: 356/51
• CPC Class Codes: G01J 3/44 Raman spectrometry; Scattering spectrometry ; Fluorescence spectrometry
• CPC Class Codes: G01N 21/65 Raman scattering

Abstract

In some embodiments, aspects of the disclosure relate to methods of evaluating cell culture materials, for example, nutrient materials, or other materials that can be used in cell culture media.

Claims

1. A method of evaluating a nutrient material, comprising:

performing a Raman spectroscopic analysis on a sample of the nutrient material to obtain a Raman spectrum; and

identifying, based the Raman spectrum, a quality of the nutrient material or a quality of a cell culture grown using the nutrient material.

2. The method of claim 1, further comprising:

differentiating the nutrient material from a second nutrient material based on a difference between the Raman spectrum of the nutrient material and a second Raman spectrum of the second nutrient material.

3. The method of claim 1, further comprising:

performing a comparison of at least a portion of the Raman spectrum with at least a portion of a model Raman spectrum.

4. The method of claim 1, further comprising:

performing a comparison of data obtained from the Raman spectrum with model data.

5. The method of claim 3, further comprising:

based on a result of the comparison, accepting the nutrient material for use in a cell culture process.

6. The method of claim 3, further comprising:

based on a result of the comparison, rejecting the nutrient material for use in a cell culture process.

7. The method of claim 1, wherein:

performing the Raman spectroscopic analysis comprises performing Surface Enhanced Raman Spectroscopy (SERS).

8. The method of claim 1, wherein:

performing the Raman spectroscopic analysis comprises performing ultraviolet (UV) Raman spectroscopy.

9. The method of claims 1, further comprising:

performing a second spectroscopic analysis on a sample of the nutrient material to obtain a second spectrum; and

performing a data fusion analysis to evaluate the Raman spectrum.

10. The method of claim 9, wherein the second spectroscopic analysis is a Nuclear Magnetic Resonance (NMR) analysis or a Near Infrared Spectroscopy (NIR) analysis.

11. The method of claim 1, further comprising identifying a value of a quality parameter based on the Raman spectrum, the quality parameter relating to the nutrient material or to a cell culture grown using the nutrient material.

12. The method of claim 11, wherein the quality parameter is a Day 8 pH.

13. The method of claim 11, wherein the quality parameter is a Peak 5.

14. The method of claim 11, wherein the quality parameter is a Lactate Production Integral.

15. The method of claim 11, wherein performing the comparison comprises predicting a value of the quality parameter based on a predictive least squares (PLS) predictive model.

16. A method of evaluating a nutrient mixture, comprising:

performing a Raman spectroscopic analysis on a sample of the nutrient material to obtain a Raman spectrum;

generating a Principal Component Analysis (PCA) model of the sample based on the Raman spectrum; and

performing a comparison of the PCA model of the sample with a reference PCA model.

17. The method of claim 16, further comprising:

based on a result of the comparison, accepting the nutrient material for use in a cell culture process.

18. The method of claim 16, further comprising:

based on a result of the comparison, rejecting the nutrient material for use in a cell culture process.

19. The method of claims 16, wherein:

performing the Raman spectroscopic analysis comprises performing Surface Enhanced Raman Spectroscopy (SERS).

20. The method of claim 16, wherein:

performing the Raman spectroscopic analysis comprises performing ultraviolet (UV) Raman spectroscopy.

21. The method of claim 16, further comprising:

performing a second spectroscopic analysis on a sample of the lot of the nutrient mixture to obtain a second spectrum; and

performing a data fusion analysis to evaluate the Raman spectrum.

22. The method of claim 21, wherein the second spectroscopic analysis is a Nuclear Magnetic Resonance (NMR) analysis or a Near Infrared Spectroscopy (NIR) analysis.