Cited by 226

Development of a Quantitative Mass Spectrometry Multi‐Attribute Method for Characterization, Quality Control Testing and Disposition of Biologics

Rogers, Richard S, Nightlinger, Nancy S, Livingston, Brittney, Campbell, Phil, Bailey, Robert, Balland, Alain·2015·mAbs

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1080/19420862.2015.1069454

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • MAM is a targeted and optimized analytical solution that uses high-resolution MS data and suitable software enabling automated identification and relative quantification of important PTMs.

    “It is a targeted and optimized analytical solution that uses a combination of high‐resolution MS data and suitable software enabling automated identification and relative quantification of important PTMs [89].”

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

No references could be resolved yet.

Research works printed but not linked: 32

  1. Gottschalk U, Brorson K, Shukla AA. Innovation in biomanufacturing: the only way forward. Pharm Bio- processing 2013; 1:141-57; http://dx.doi.org/10.4155/ pbp.13.17 · DOI
  2. McLaughlin J, Banerjee A. Biopharmaceutical manufacturing and flexible design: what does the future hold? Pharm Bioprocessing 2014; 2:215-7; http://dx. doi.org/10.4155/pbp.14.20 · DOI
  3. International Conference on Harmonisation of Techni- cal Requirements for Registration of Pharmaceuticals for Human Use. Quality Risk Management Q9. 2006. Available at: http://www.ich.org/products/guidelines/ quality/article/quality-guidelines.html
  4. International Conference on Harmonisation of Technical Requirements for Registration of Pharma- ceuticals for Human Use. Pharmaceutical Quality Systems (Q10). 2008. Available at: http://www.ich. org/products/guidelines/quality/article/quality-guide lines.html
  5. International Conference on Harmonisation of Technical Requirements for Registration of Pharma- ceuticals for Human Use. Pharmaceutical Develop- ment Q8(R2). 2009. Available at: http://www.ich. org/products/guidelines/quality/article/quality-guide lines.html
  6. Aksu B, Paradkar A, de Matas M, Ozer O, Guneri T, York P. Quality by design approach: application of arti- ficial intelligence techniques of tablets manufactured by direct compression. AAPS PharmSciTech 2012; 13:1138-46; PMID:22956056; http://dx.doi.org/ 10.1208/s12249-012-9836-x · DOI
  7. Kessel M. The problems with today's pharmaceutical business-an outsider's view. Nature Biotechnol 2011; 29:27-33; http://dx.doi.org/10.1038/nbt.1748 · DOI
  8. Aksu B, De Beer T, Folestad S, Ketolainen J, Linden H, Lopes JA, de Matas M, Oostra W, Rantanen J, Weimer M. Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT). Eur J Pharm Sci 2012; 47:402-5; PMID:22749874; http://dx.doi.org/ 10.1016/j.ejps.2012.06.009 · DOI
  9. Luciani F, Galluzzo S, Gaggioli A, Kruse NA, Ven- neugues P, Schneider CK, Pini C, Melchiorri D. Implementing quality by design for biotech products: Are regulators on track? mAbs 2015; 7:451-5; PMID:25853461; http://dx.doi.org/10.1080/ 19420862.2015.1023058 · DOI
  10. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical qual- ity by design. AAPS J 2014; 16:771-83; PMID:24854893; http://dx.doi.org/10.1208/s12248- 014-9598-3 · DOI · Paper page
  11. Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianferani S. Characterization of therapeu- tic antibodies and related products. Anal Chem 2013; 85:715-36; PMID:23134362; http://dx.doi.org/ 10.1021/ac3032355 · DOI
  12. Kaltashov IA, Bobst CE, Abzalimov RR, Wang G, Bay- kal B, Wang S. Advances and challenges in analytical characterization of biotechnology products: mass spec- trometry-based approaches to study properties and behavior of protein therapeutics. Biotechnol Adv 2012; 30:210-22; PMID:21619926; http://dx.doi.org/ 10.1016/j.biotechadv.2011.05.006 · DOI
  13. Sandra K, Vandenheede I, Sandra P. Modern chro- matographic and mass spectrometric techniques for protein biopharmaceutical characterization. J Chroma- togr A 2014; 1335:81-103; PMID:24365115; http:// dx.doi.org/10.1016/j.chroma.2013.11.057 · DOI
  14. Zhang Z. Large-scale identification and quantification of covalent modifications in therapeutic proteins. Anal Chem 2009; 81:8354-64; PMID:19764700; http://dx. doi.org/10.1021/ac901193n · DOI
  15. Kozlowski S, Nashabeh W, Schenerman M, Anderson H, Blumentals I, Ho K, Mahtre R, Rellahan B, Vinci V, McLeod L. QbD for Biologics: Learning from the Product Development and Realization (A-MAb) Case Study and the FDA OBP Pilot Program. BioProcess International 2012; 10:18-29;
  16. Rathore AS, Winkle H. Quality by design for bio- pharmaceuticals. Nat Biotechnol 2009; 27:26-34; PMID:19131992; http://dx.doi.org/10.1038/ nbt0109-26 · DOI
  17. Aggarwal RS. What's fueling the biotech engine-2012 to 2013. Nat Biotechnol 2014; 32:32-9; PMID:24406926; http://dx.doi.org/10.1038/nbt.2794 · DOI
  18. Walsh G. Biopharmaceutical benchmarks 2014. Nat Biotechnol 2014; 32:992-1000; PMID:25299917; http://dx.doi.org/10.1038/nbt.3040 · DOI · Paper page
  19. Reichert JM. Antibodies to watch in 2014. mAbs 2014; 6:5-14; PMID:24284914; http://dx.doi.org/10.4161/ mabs.27333 · DOI
  20. Valliere-Douglass J, Wallace A, Balland A. Separation of populations of antibody variants by fine tuning of hydrophobic-interaction chromatography operating conditions. J Chromatogr A 2008; 1214:81-9; PMID:19012891; http://dx.doi.org/10.1016/j. chroma.2008.10.078 · DOI
  21. Zhao SS, Chen DD. Applications of capillary electro- phoresis in characterizing recombinant protein thera- peutics. Electrophoresis 2014; 35:96-108; PMID:24123141; http://dx.doi.org/10.1002/ elps.201300372 · DOI
  22. Federici M, Lubiniecki A, Manikwar P, Volkin DB. Analytical lessons learned from selected therapeutic protein drug comparability studies. Biologicals 2013; 41:131-47; PMID:23146362; http://dx.doi.org/ 10.1016/j.biologicals.2012.10.001 · DOI
  23. Brady LJ, Velayudhan J, Visone DB, Daugherty KC, Bartron JL, Coon M, Cornwall C, Hinckley PJ, Con- nell-Crowley L. The criticality of high-resolution N- linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimi- lar development. mAbs 2015; 7(3):562-70; PMID:25898160; http://dx.doi.org/10.1080/ 19420862.2015.1016692 · DOI
  24. Goetze AM, Liu YD, Zhang Z, Shah B, Lee E, Bondar- enko PV, Flynn GC. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology 2011; 21:949-59; PMID:21421994; http://dx.doi.org/10.1093/glycob/ cwr027 · DOI · Paper page
  25. Jefferis R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol Sci 2009; 30:356-62; PMID:19552968; http://dx.doi.org/10.1016/j. tips.2009.04.007 · DOI
  26. Shah B, Jiang XG, Chen L, Zhang Z. LC-MS/MS pep- tide mapping with automated data processing for rou- tine profiling of N-glycans in immunoglobulins. J Am Soc Mass Spectrom 2014; 25:999-1011; PMID:24664809; http://dx.doi.org/10.1007/s13361- 014-0858-3 · DOI
  27. Arora T, Green R, Mercer J, Tsang P, Casais M, Feld- man S, Look J, Lubinecky T, Mezzatesta J, Pluschke A, et al. Quality by design for biotechnology products. Biopharm Int 2009; 22:26-36
  28. Brady LJ, Scott RA, Balland A. An optimized approach to the rapid assessment and detection of sequence var- iants in recombinant protein products. Anal Bioanal Chem 2015; 407:3851-60; PMID:25795027; http:// dx.doi.org/10.1007/s00216-015-8618-1 · DOI
  29. Zhang Z, Shah B, Bondarenko PV. G/U and certain wobble position mismatches as possible main causes of amino acid misincorporations. Biochemistry 2013; 52:8165-76; PMID:24128183; http://dx.doi.org/ 10.1021/bi401002c · DOI
  30. Schenauer MR, Flynn GC, Goetze AM. Profiling the effects of process changes on residual host cell proteins in biotherapeutics by mass spectrometry. Biotechnol Prog 2013; 29:951-7; PMID:23696295; http://dx.doi. org/10.1002/btpr.1748 · DOI
  31. Pais DA, Carrondo MJ, Alves PM, Teixeira AP. Towards real-time monitoring of therapeutic protein quality in mammalian cell processes. Curr Opin Bio- technol 2014; 30C:161-7; PMID:25035940; http://dx. doi.org/10.1016/j.copbio.2014.06.019 · DOI
  32. Rathore A, Krull IS, Mendhe R. Analytical Tools for enabling process analytical technology (PAT) applica- tions in biotechnology. LCGC North Am 2012; 30:52-63

Cited by

Sorted by citations

Authors
Rogers, R. S., Nightlinger, N. S., Livingston, B., Campbell, P., Bailey, R., & Balland, A.
Venue
mAbs
Published
2015-07-17
Volume
7
Issue
5
Pages
881-890
ISSN
  • 1942-0862
  • 1942-0870
Cited by
226
References
0
Language
en

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review