Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Overlay of RP-HPLC chromatograms of endoproteinase Glu-C digested of Filgrastim CRS, Neupogen batch 1056681, Tevagrastim, copy products and several batches of Neupogen.

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques:

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Circular dichroism spectra of filgrastim products at (a) 25 and (b) 55°C. Average curve represents the spectra of the expired bathes of Neupogen (black line), Neupogen batch 1056681 (red line), Tevagrastim (blue line), Biocilin (green line) and PDgrastim (pink line).

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques: Circular Dichroism

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Thermal stability of selected filgrastim products monitored by ( a ) circular dichroism at 222 nm and ( b ) intrinsic fluorescence from 25 to 70°C. Average curves represent the results for expired batches of Neupogen (black line), Neupogen batch 1056681 (red line), Tevagrastim (blue line), Biocilin (green line) and PDgrastim (pink line).

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques: Circular Dichroism, Fluorescence

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Filgrastim products on 4–12% Bolt® Bis­Tris gel visualized by silver staining. Neupogen (NE) batch 1042036A, PDgrastim (PD), Zarzio (ZA), Tevagrastim (TE) and Biocilin (BI) as well as additional batches of Neupogen (A-G).

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques: Silver Staining

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: HP­SEC chromatograms of (top to bottom) Biocilin (green), Tevagrastim (pink), Zarzio (brown), and Neupogen batch 1042036A (black) followed by seven batches of expired Neupogen (several shades of blue) and PDgrastim (purple). The inset is the zoom of PDgrastim’s chromatogram. Peak (a) is filgrastim dimer and peak (b) is filgrastim oligomer.

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques:

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Comparison of Monomer Content and Potency of Tested Filgrastim Products

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques: Comparison, In Vitro, Fluorescence, Activity Assay

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: RP-UPLC chromatograms of ( a ) filgrastim CRS, ( b ) biosimilar and copy filgrastim products, and ( c ) expired batches of Neupogen compared to non-expired Neupogen.

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques:

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Representative images of protein-like and silicone oil droplet-like particles observed by MFI in selected filgrastim products.

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques:

Journal: Pharmaceutical Research

Article Title: Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

doi: 10.1007/s11095-018-2491-5

Figure Lengend Snippet: Comparison of Protein-Like Particles and Silicone Oil Droplet-Like Particle Concentrations (Particles/ml) in Some Filgrastim Products Measured by MFI

Article Snippet: Filgrastim chemical reference substances (CRS) with lot number 2, purchased from the European Directorate for the Quality of Medicines and HealthCare (EDQM, Strasbourg, France) and filgrastim samples were pre-concentrated by using Amicon® Ultra-0.5 ml centrifugal filters with a cut-off of 10,000 NWML (Merck Millipore, Amsterdam, The Netherlands) following the manufacturer’s recommendations.

Techniques: Comparison

Journal: Medikamente in der Tumortherapie

Article Title: Medikamentenprofile – alphabetisch nach Substanzname

doi: 10.1007/978-3-662-55356-5_2

Figure Lengend Snippet:

Article Snippet: CH: , Neupogen, Filgrastim-Teva, Zarzio , Fertigspritzen zu 30 Mio. I.E., 48 Mio. I.E. Durchstechflaschen – Lösung zu 30 Mio. I.E. *.

Techniques: