capto mmc resin  (Eppendorf AG)

Journal: Pharmaceutics

Article Title: Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur ® ) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency

doi: 10.3390/pharmaceutics14010096

Figure Lengend Snippet: Stability studies for multimodal chromatography (step 1) and immunoaffinity chromatography (step 2). ( A ) Total FSH breakthrough at applying 1.9 mg FSH/mL Capto MMC resin in control cycles (area under breakthrough curve) as measured by enzyme-linked immunosorbent assay. Downscaling 1:125 in cycle 1 (Tricorn 5/200 column, bed volume 4 mL), 1:500 in the remaining cycles (Tricorn 5/50 column, bed volume 1 mL). Loaded 1.9 mg FSH/mL resin, residence time 2 min (cycle 1), 40 s (cycle 2), 1 min (cycles 3, 30, 40). Data are mean values, and error bars represent standard deviation (n = 2). ( B ) Peak volume integration for eluates in 40 working cycles, absorbance channel at 280 nm. Capto MMC resin, downscaling 1:400 (Tricorn 5/50 column, bed volume 1 mL). Loaded 1.3 mg FSH/mL resin, residence time 1 min. ( C ) FSH eluted from immunoaffinity column. CaptureSelect FSH Affinity Matrix, downscaling 1:700 (Tricorn 5/50 column, bed volume 1 mL). Loaded 2 mg FSH/mL resin, residence time 1 min. FSH content in the eluates measured by absorption at 280 nm. ( D ) Peak volume integration for eluates from 1 mL column filled with CaptureSelect FSH Affinity Matrix. Loaded 1.1 mg FSH/mL resin, downscaling 1:700, residence time 1 min. Data for 40 working cycles in absorbance channel at 280 nm.

Article Snippet: The initial product capture step aimed at isolation and concentration was performed using two columns filled with Capto MMC resin: a Tricorn 5/200 column (Cytiva) packed with 4 mL of the resin was used for DBC determination (downscaling 1:125, column volume/column volume, CV/CV), and a Tricorn 5/50 column (Cytiva) packed with 1 mL of the resin was used to determine the optimal residence time and the cycling studies (downscaling 1:500, CV/CV).

Techniques: Chromatography, Control, Enzyme-linked Immunosorbent Assay, Standard Deviation

Journal: Pharmaceutics

Article Title: Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur ® ) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency

doi: 10.3390/pharmaceutics14010096

Figure Lengend Snippet: Target protein loss at DBC 10% for Capto MMC resin at various residence times. Data for cycles 1–3.

Article Snippet: The initial product capture step aimed at isolation and concentration was performed using two columns filled with Capto MMC resin: a Tricorn 5/200 column (Cytiva) packed with 4 mL of the resin was used for DBC determination (downscaling 1:125, column volume/column volume, CV/CV), and a Tricorn 5/50 column (Cytiva) packed with 1 mL of the resin was used to determine the optimal residence time and the cycling studies (downscaling 1:500, CV/CV).

Techniques:

Journal: Pharmaceutics

Article Title: Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur ® ) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency

doi: 10.3390/pharmaceutics14010096

Figure Lengend Snippet: Stability studies for desalting by size-exclusion, ion exchange chromatography, and final size-exclusion chromatography (steps 3, 4, and 5, accordingly). ( A ) Eluate peak broadening for Tricorn 5/200 column, bed volume 4 mL, Sephadex G25 Medium resin (downscaling 1:500), conductivity channel, 40 cycles, six loads in each cycle. Sample volume 0.75 mL. ( B ) Eluate peak broadening for Tricorn 10/300 column, bed volume 24 mL, Superdex75 pg resin (downscaling 1:100), absorbance channel at 280 nm, 40 cycles. Sample volume 1 mL. ( C ) BSA eluted from Capto Q column in control cycles. Tricorn 5/50 column, bed volume 1 mL, Capto Q resin (downscaling 1:50). Loaded 320 mg BSA/mL resin, residence time 1.67 min. BSA content measured by absorption at 280 nm of the collected eluates. ( D ) Peak volume integration for eluates in working cycles, absorbance channel at 280 nm. Same column as in panel C. Loaded 30 mg BSA/mL resin, residence time 1.67 min.

Article Snippet: The initial product capture step aimed at isolation and concentration was performed using two columns filled with Capto MMC resin: a Tricorn 5/200 column (Cytiva) packed with 4 mL of the resin was used for DBC determination (downscaling 1:125, column volume/column volume, CV/CV), and a Tricorn 5/50 column (Cytiva) packed with 1 mL of the resin was used to determine the optimal residence time and the cycling studies (downscaling 1:500, CV/CV).

Techniques: Ion Exchange Chromatography, Size-exclusion Chromatography, Control

Journal: Pharmaceutics

Article Title: Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur ® ) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency

doi: 10.3390/pharmaceutics14010096

Figure Lengend Snippet: Reduction factor (RF) for model viruses pseudorabies virus (PRV), parainfluenza virus (PIV), reovirus type-3 (REO), and encephalomyocarditis virus (EMC) in five downstream steps of r-hFSH.

Article Snippet: The initial product capture step aimed at isolation and concentration was performed using two columns filled with Capto MMC resin: a Tricorn 5/200 column (Cytiva) packed with 4 mL of the resin was used for DBC determination (downscaling 1:125, column volume/column volume, CV/CV), and a Tricorn 5/50 column (Cytiva) packed with 1 mL of the resin was used to determine the optimal residence time and the cycling studies (downscaling 1:500, CV/CV).

Techniques: Virus, Solvent, Ion Exchange Chromatography, Membrane, Chromatography