Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study.

Autor: Mouchahoir T; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, Maryland 20899, United States.; Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, Maryland 20850, United States., Schiel JE; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, Maryland 20899, United States.; Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, Maryland 20850, United States., Rogers R; Just-Evotech Biologics, Inc., 401 Terry Ave N., Seattle, Washington 98109, United States., Heckert A; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, Maryland 20899, United States., Place BJ; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, Maryland 20899, United States., Ammerman A; AbbVie, 1000 Gateway Blvd, South San Francisco, California 94080, United States., Li X; AbbVie, 1000 Gateway Blvd, South San Francisco, California 94080, United States., Robinson T; AbbVie, 1000 Gateway Blvd, South San Francisco, California 94080, United States., Schmidt B; AbbVie, 1000 Gateway Blvd, South San Francisco, California 94080, United States., Chumsae CM; AbbVie, 100 Research Drive, Worcester, Massachusetts 01605, United States., Li X; AbbVie, 100 Research Drive, Worcester, Massachusetts 01605, United States., Manuilov AV; AbbVie, 100 Research Drive, Worcester, Massachusetts 01605, United States., Yan B; AbbVie, 100 Research Drive, Worcester, Massachusetts 01605, United States., Staples GO; Agilent Technologies, 5301 Stevens Creek Blvd, Santa Clara, California 95008, United States., Ren D; Amgen, One Amgen Center Dr, Thousand Oaks, California 91320, United States., Veach AJ; Amgen, One Amgen Center Dr, Thousand Oaks, California 91320, United States., Wang D; BioAnalytix, 790 Memorial Dr, Cambridge, Massachusetts 02139, United States., Yared W; BioAnalytix, 790 Memorial Dr, Cambridge, Massachusetts 02139, United States., Sosic Z; Biogen, 125 Broadway, Cambridge, Massachusetts 02142, United States., Wang Y; Biogen, 125 Broadway, Cambridge, Massachusetts 02142, United States., Zang L; Biogen, 125 Broadway, Cambridge, Massachusetts 02142, United States., Leone AM; Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534, United States., Liu P; Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534, United States., Ludwig R; Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534, United States., Tao L; Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534, United States., Wu W; Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534, United States., Cansizoglu A; Charles River Laboratories, 8 Henshaw Street, Shrewsbury, Massachusetts 01801, United States., Hanneman A; Charles River Laboratories, 8 Henshaw Street, Shrewsbury, Massachusetts 01801, United States., Adams GW; FUJIFILM Diosynth Biotechnologies, 101 J. Morris Commons Ln, Morrisville, North Carolina 27560, United States., Perdivara I; FUJIFILM Diosynth Biotechnologies, 101 J. Morris Commons Ln, Morrisville, North Carolina 27560, United States., Walker H; FUJIFILM Diosynth Biotechnologies, 101 J. Morris Commons Ln, Morrisville, North Carolina 27560, United States., Wilson M; FUJIFILM Diosynth Biotechnologies, 101 J. Morris Commons Ln, Morrisville, North Carolina 27560, United States., Brandenburg A; Genedata, Margarethenstrasse 38, Basel, 4053, Switzerland., DeGraan-Weber N; Genedata, 750 Marrett Road, One Cranberry Hill, Lexington, Massachusetts 02421, United States., Gotta S; Genedata, Margarethenstrasse 38, Basel, 4053, Switzerland., Shambaugh J; Genedata, 750 Marrett Road, One Cranberry Hill, Lexington, Massachusetts 02421, United States., Alvarez M; Genentech, 1 DNA Way, South San Francisco, California 94080, United States., Yu XC; Genentech, 1 DNA Way, South San Francisco, California 94080, United States., Cao L; GSK, 709 Swedeland Rd, King of Prussia, Pennsylvania 19406, United States., Shao C; GSK, 709 Swedeland Rd, King of Prussia, Pennsylvania 19406, United States., Mahan A; Janssen, 1400 McKean Road, Springhouse, Pennsylvania 19477, United States., Nanda H; Janssen, 1400 McKean Road, Springhouse, Pennsylvania 19477, United States., Nields K; Janssen, 1400 McKean Road, Springhouse, Pennsylvania 19477, United States., Nightlinger N; Just-Evotech Biologics, Inc., 401 Terry Ave N., Seattle, Washington 98109, United States., Niu B; AstraZeneca, One MedImmune Way, Gaithersburg, Maryland 20878, United States., Wang J; AstraZeneca, One MedImmune Way, Gaithersburg, Maryland 20878, United States., Xu W; AstraZeneca, One MedImmune Way, Gaithersburg, Maryland 20878, United States., Leo G; EMD Serono an affiliate of Merck KGaA, Darmstadt, Germany, Via Luigi Einaudi 11, Guidonia Montecelio (Roma), 00012, Italy., Sepe N; EMD Serono an affiliate of Merck KGaA, Darmstadt, Germany, Via Luigi Einaudi 11, Guidonia Montecelio (Roma), 00012, Italy., Liu YH; Merck & Co., Inc.., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033, United States., Patel BA; Merck & Co., Inc.., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033, United States., Richardson D; Merck & Co., Inc.., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033, United States., Wang Y; Merck & Co., Inc.., 2000 Galloping Hill Rd, Kenilworth, New Jersey 07033, United States., Tizabi D; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, Maryland 20899, United States.; Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, Maryland 20850, United States., Borisov OV; Novavax, Inc., 20 Firstfield Road, Gaithersburg, Maryland 20878, United States., Lu Y; Novavax, Inc., 20 Firstfield Road, Gaithersburg, Maryland 20878, United States., Maynard EL; Novavax, Inc., 20 Firstfield Road, Gaithersburg, Maryland 20878, United States., Gruhler A; Novo Nordisk, Novo Nordisk Park, Måløv 2760, Denmark., Haselmann KF; Novo Nordisk, Novo Nordisk Park, Måløv 2760, Denmark., Krogh TN; Novo Nordisk, Novo Nordisk Park, Måløv 2760, Denmark., Sönksen CP; Novo Nordisk, Novo Nordisk Park, Måløv 2760, Denmark., Letarte S; Pfizer, 375 N Field Dr, Lake Forest, Illinois 60045, United States., Shen S; Pfizer, 375 N Field Dr, Lake Forest, Illinois 60045, United States., Boggio K; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Johnson K; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Ni W; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Patel H; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Ripley D; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Rouse JC; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Zhang Y; Pfizer, 1 Burtt Rd, Andover, Massachusetts 01810, United States., Daniels C; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Dawdy A; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Friese O; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Powers TW; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Sperry JB; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Woods J; Pfizer, 700 Chesterfield Pkwy West, Chesterfield, Missouri 63017, United States., Carlson E; Protein Metrics, Inc., 20863 Stevens Creek Blvd, Cupertino, California 95014, United States., Sen KI; Protein Metrics, Inc., 20863 Stevens Creek Blvd, Cupertino, California 95014, United States., Skilton SJ; Protein Metrics, Inc., 20863 Stevens Creek Blvd, Cupertino, California 95014, United States., Busch M; Sanofi, 1 The Mountain Rd, Framingham, Massachusetts 01701, United States., Lund A; Sanofi, 1 The Mountain Rd, Framingham, Massachusetts 01701, United States., Stapels M; Sanofi, 1 The Mountain Rd, Framingham, Massachusetts 01701, United States., Guo X; SCIEX, 71 Four Valley Drive, Concord, ON L4K 4V8, Canada., Heidelberger S; SCIEX, 71 Four Valley Drive, Concord, ON L4K 4V8, Canada., Kaluarachchi H; SCIEX, 71 Four Valley Drive, Concord, ON L4K 4V8, Canada., McCarthy S; SCIEX, 500 Old Connecticut Path, Framingham, Massachusetts 01701, United States., Kim J; Teva, 145 Brandywine Pkwy, West Chester, Pennsylvania 19380, United States., Zhen J; Teva, 145 Brandywine Pkwy, West Chester, Pennsylvania 19380, United States., Zhou Y; Teva, 145 Brandywine Pkwy, West Chester, Pennsylvania 19380, United States., Rogstad S; U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland 20993, United States., Wang X; U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland 20993, United States., Fang J; Waters, 34 Maple St, Milford, Massachusetts 01757, United States., Chen W; Waters, 34 Maple St, Milford, Massachusetts 01757, United States., Yu YQ; Waters, 34 Maple St, Milford, Massachusetts 01757, United States., Hoogerheide JG; Zoetis, 333 Portage St, Kalamazoo, Michigan 49007, United States., Scott R; Zoetis, 333 Portage St, Kalamazoo, Michigan 49007, United States., Yuan H; Zoetis, 333 Portage St, Kalamazoo, Michigan 49007, United States.
Jazyk: angličtina
Zdroj: Journal of the American Society for Mass Spectrometry [J Am Soc Mass Spectrom] 2022 Sep 07; Vol. 33 (9), pp. 1659-1677. Date of Electronic Publication: 2022 Aug 26.
DOI: 10.1021/jasms.2c00129
Abstrakt: The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in traditional peptide mapping methods; it leverages mass spectrometry (MS) detection for confident identification and quantitation of many types of protein attributes that may be targeted for monitoring. While MAM has been widely explored across the industry, it has yet to gain a strong foothold within QC laboratories as a replacement method for established orthogonal platforms. Members of the MAM consortium recently undertook an interlaboratory study to evaluate the industry-wide status of MAM. Here we present the results of this study as they pertain to the targeted attribute analytics component of MAM, including investigation into the sources of variability between laboratories and comparison of MAM data to orthogonal methods. These results are made available with an eye toward aiding the community in further optimizing the method to enable its more frequent use in the QC environment.
Databáze: MEDLINE