Protein Quality Testing in the Era of Personalized Medicine (2024)

Doevendans, E., & Schellekens, H. (2020). Protein Quality Testing in the Era of Personalized Medicine. Journal of Pharmaceutical Sciences, 109(10), 2962-2968. https://doi.org/10.1016/j.xphs.2020.07.009

Doevendans, Erik ; Schellekens, Huub. / Protein Quality Testing in the Era of Personalized Medicine. In: Journal of Pharmaceutical Sciences. 2020 ; Vol. 109, No. 10. pp. 2962-2968.

@article{b2956f7db11c404cb4add9a1ff798834,

title = "Protein Quality Testing in the Era of Personalized Medicine",

abstract = "The current pharmaceutical system is not sustainable; new drugs have limited impact on public health, they are (too) expensive and innovation has stalled because of overregulation of the industry. We suggest reviving compounding by pharmacists as the pharmaceutical model for the future allowing for innovation. Bedside production of biologics by magistral compounding under direct control by a pharmacist is considered key to the introduction of personalized medicines. Although specific regulations are lacking, appropriate quality testing will be essential for magistral preparations to be accepted by patients and doctors. In classical drug development a myriad of different, often redundant, techniques are being used for protein characterization. In most cases, the specification of these test are set based on history, the cut-off of the test, specifications of comparable products rather than on clinically set limits. Here, we propose a quality testing approach for two hypothetical biopharmaceuticals, a monoclonal antibody and an enzyme replacement therapy, based on common sense and a risk analysis.",

keywords = "Regulatory science, Biotechnology, Antibody drug(s), Formulation, Protein(s)",

author = "Erik Doevendans and Huub Schellekens",

note = "Copyright {\textcopyright} 2020 American Pharmacists Association{\textregistered}. Published by Elsevier Inc. All rights reserved.",

year = "2020",

month = oct,

day = "1",

doi = "10.1016/j.xphs.2020.07.009",

language = "English",

volume = "109",

pages = "2962--2968",

journal = "Journal of Pharmaceutical Sciences",

issn = "0022-3549",

publisher = "John Wiley and Sons Inc.",

number = "10",

}

Doevendans, E & Schellekens, H 2020, 'Protein Quality Testing in the Era of Personalized Medicine', Journal of Pharmaceutical Sciences, vol. 109, no. 10, pp. 2962-2968. https://doi.org/10.1016/j.xphs.2020.07.009

Protein Quality Testing in the Era of Personalized Medicine. / Doevendans, Erik; Schellekens, Huub.
In: Journal of Pharmaceutical Sciences, Vol. 109, No. 10, 01.10.2020, p. 2962-2968.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Protein Quality Testing in the Era of Personalized Medicine

AU - Doevendans, Erik

AU - Schellekens, Huub

N1 - Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

PY - 2020/10/1

Y1 - 2020/10/1

N2 - The current pharmaceutical system is not sustainable; new drugs have limited impact on public health, they are (too) expensive and innovation has stalled because of overregulation of the industry. We suggest reviving compounding by pharmacists as the pharmaceutical model for the future allowing for innovation. Bedside production of biologics by magistral compounding under direct control by a pharmacist is considered key to the introduction of personalized medicines. Although specific regulations are lacking, appropriate quality testing will be essential for magistral preparations to be accepted by patients and doctors. In classical drug development a myriad of different, often redundant, techniques are being used for protein characterization. In most cases, the specification of these test are set based on history, the cut-off of the test, specifications of comparable products rather than on clinically set limits. Here, we propose a quality testing approach for two hypothetical biopharmaceuticals, a monoclonal antibody and an enzyme replacement therapy, based on common sense and a risk analysis.

AB - The current pharmaceutical system is not sustainable; new drugs have limited impact on public health, they are (too) expensive and innovation has stalled because of overregulation of the industry. We suggest reviving compounding by pharmacists as the pharmaceutical model for the future allowing for innovation. Bedside production of biologics by magistral compounding under direct control by a pharmacist is considered key to the introduction of personalized medicines. Although specific regulations are lacking, appropriate quality testing will be essential for magistral preparations to be accepted by patients and doctors. In classical drug development a myriad of different, often redundant, techniques are being used for protein characterization. In most cases, the specification of these test are set based on history, the cut-off of the test, specifications of comparable products rather than on clinically set limits. Here, we propose a quality testing approach for two hypothetical biopharmaceuticals, a monoclonal antibody and an enzyme replacement therapy, based on common sense and a risk analysis.

KW - Regulatory science

KW - Biotechnology

KW - Antibody drug(s)

KW - Formulation

KW - Protein(s)

U2 - 10.1016/j.xphs.2020.07.009

DO - 10.1016/j.xphs.2020.07.009

M3 - Article

C2 - 32673626

SN - 0022-3549

VL - 109

SP - 2962

EP - 2968

JO - Journal of Pharmaceutical Sciences

JF - Journal of Pharmaceutical Sciences

IS - 10

ER -

Doevendans E, Schellekens H. Protein Quality Testing in the Era of Personalized Medicine. Journal of Pharmaceutical Sciences. 2020 Oct 1;109(10):2962-2968. doi: 10.1016/j.xphs.2020.07.009