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The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein.
Defante, Adrian P; Kalonia, Cavan K; Keegan, Emma; Bishop, Steven M; Satish, Hasige A; Hudson, Steven D; Santacroce, Paul V.
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  • Defante AP; Material Measurement Laboratory , National Institute of Standards and Technology (NIST) , Gaithersburg , Maryland 20899 , United States.
  • Kalonia CK; Dosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
  • Keegan E; Dosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
  • Bishop SM; Dosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
  • Satish HA; Dosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
  • Hudson SD; Material Measurement Laboratory , National Institute of Standards and Technology (NIST) , Gaithersburg , Maryland 20899 , United States.
  • Santacroce PV; Dosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
Mol Pharm ; 17(2): 569-578, 2020 02 03.
Article en En | MEDLINE | ID: mdl-31917583
Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for subvisible particle counts, in comparison to a ceramic pump head. The quartz crystal microbalance was used to quantify the primary layer, proteins irreversibly adsorbed at the solid-liquid interface, and the secondary diffuse gel-like layer interacting on top of the primary layer. The results showed that the mass of protein irreversibly adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role in surface-induced protein aggregation at the solid-liquid interface.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Acero Inoxidable / Inmunoglobulina G / Fragmentos Fc de Inmunoglobulinas / Factor de Necrosis Tumoral alfa / Composición de Medicamentos / Anticuerpos Monoclonales Humanizados Idioma: En Revista: Mol Pharm Asunto de la revista: BIOLOGIA MOLECULAR / FARMACIA / FARMACOLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Acero Inoxidable / Inmunoglobulina G / Fragmentos Fc de Inmunoglobulinas / Factor de Necrosis Tumoral alfa / Composición de Medicamentos / Anticuerpos Monoclonales Humanizados Idioma: En Revista: Mol Pharm Asunto de la revista: BIOLOGIA MOLECULAR / FARMACIA / FARMACOLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos