Buffer capacity of biologics—from buffer salts to buffering by antibodies

AR Karow, S Bahrenburg, P Garidel - Biotechnology progress, 2013 - Wiley Online Library
Controlling pH is essential for a variety of biopharmaceutical process steps. The chemical
stability of biologics such as monoclonal antibodies is pH‐dependent and slightly acidic …

Buffer‐free therapeutic antibody preparations provide a viable alternative to conventionally buffered solutions: From protein buffer capacity prediction to bioprocess …

S Bahrenburg, AR Karow, P Garidel - Biotechnology journal, 2015 - Wiley Online Library
Protein therapeutics, including monoclonal antibodies (mAbs), have significant buffering
capacity, particularly at concentrations> 50 mg/mL. This report addresses pH‐related issues …

Effects of phosphate buffer in parenteral drugs on particle formation from glass vials

T Ogawa, M Miyajima, N Wakiyama… - Chemical and …, 2013 - jstage.jst.go.jp
The characteristics of inorganic particles generated in glass vials filled with phosphate buffer
solutions were investigated. During storage, particles were visually detected in the …

[HTML][HTML] Surface treatment of glass vials for lyophilization: implications for vacuum-induced surface freezing

F Regis, A Arsiccio, E Bourlès, B Scutellà, R Pisano - Pharmaceutics, 2021 - mdpi.com
Freeze-drying is commonly used to increase the shelf-life of pharmaceuticals and
biopharmaceuticals. Freezing represents a crucial phase in the freeze-drying process, as it …

Comparisons of aluminum and silica elution from various glass vials

T Ogawa, M Miyajima, N Nishimoto… - Chemical and …, 2016 - jstage.jst.go.jp
To understand the risk of particle formation in glass vials, we investigated the correlation
between vial surface condition and alminum (Al) or silicon (Si) elution using various …

Aluminum elution and precipitation in glass vials: Effect of pH and buffer species

T Ogawa, M Miyajima, N Wakiyama… - Drug Development and …, 2015 - Taylor & Francis
Inorganic extractables from glass vials may cause particle formation in the drug solution. In
this study, the ability of eluting Al ion from borosilicate glass vials, and tendencies of …

Factors Affecting Drug Quality Problems in Thailand

S Ongoagchai, M Harun‐Or‐Rashid… - The Quality …, 2011 - Wiley Online Library
Poor drug quality is a global concern as it can cause treatment failure, adverse effects,
increased morbidity, mortality and development of drug resistance. This study was aimed to …

[PDF][PDF] Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing. Pharmaceutics 2021, 13, 1766

F Regis, A Arsiccio, E Bourlès, B Scutellà, R Pisano - 2021 - academia.edu
Freeze-drying is commonly used to increase the shelf-life of pharmaceuticals and
biopharmaceuticals. Freezing represents a crucial phase in the freeze-drying process, as it …

[PDF][PDF] Vacuum Induced Surface Freezing (VISF) and surface treatment of containers

R Pisano, F Regis - 2020 - webthesis.biblio.polito.it
La liofilizzazione è un processo utilizzato nell'industria farmaceutica, ma non solo, per
rimuovere il solvente (acqua o altro) da un farmaco senza danneggiare la struttura …

Vacuum Induced Surface Freezing (VISF) and surface treatment of containers

F Regis - 2020 - webthesis.biblio.polito.it
La liofilizzazione è un processo utilizzato nell'industria farmaceutica, ma non solo, per
rimuovere il solvente (acqua o altro) da un farmaco senza danneggiare la struttura …