(CAT#: STEM-C-2542-LC)Ĭopyright © 2023 STEMart. Capto adhere is a multimodal BioProcess resin designed for post-protein A purification of monoclonal antibodies (mAbs) at process scale (Fig 1). Inertsil ODS-4 Analytical Columns, Particle Size 3µm HP, I.D. Use our Chemical Compatibility Chart as guide for evaluating the resistance of polymer and metal materials. Use this chart to help guide your component selection. Pinnacle DB Cyano Columns (USP L10), Particle Size 5 μm, Length 30 mm, ID 2.1 mm, Restek (CAT#: STEM-C-1189-LC) This Chemical Compatibility Chart is a shorthand tool for describing the suitability of miniature fluidic and pneumatic component materials for use in contact with various chemicals.InertSustain C18 Packed Guard Columns, Particle Size 3µm, I.D.due in part to the excellent chemical tolerance of the ruthenium. Inertsil ODS-3 Analytical Columns, Particle Size 5µm, I.D. Critical to this ' grafting - from ' process is the compatibility of the nanoparticle.Figure 2 above shows the possible combinations of bed height and operational nominal flow velocity for Capto L. Choose bed height and operating flow velocity in terms of residence time, pressure restrictions and large-scale column packing challenges. Rtx-200 Columns (Fused Silica), Length 30 m, ID 0.32 mm, df 1.00 μm, Temp. Fig 2.Operating window for Capto L (white area).Viva C4 Columns (USP L26), Particle Size 5 μm, Length 100 mm, ID 3.0 mm, Restek (CAT#: STEM-C-1293-LC).Inertsil ODS-SP Analytical Columns, Particle Size 3µm, I.D.HiTrap Capto S ImpAct columns provide fast, reproducible and easy separations in a convenient format. Inertsil ODS-3 Guard Columns For UHPLC, Replacement Cartridge (2/pk) & Holder Set For UHPLC, Particle Size 3µm, I.D. HiTrap Capto S ImpAct (1 ml and 5 ml) are prepacked columns for small scale purifications, as well as optimization of methods and parameters, such as sample load and binding conditions.This method enabled > 90 % overall recovery of unformulated DS at ≥ 150 g/L. Most of the rinse was combined with the retentate to hit the target protein concentration. After the retentate was collected, a minimal volume of buffer was added for the UF rinse. During the UF/DF process, the antibody was initially concentrated to 90 g/L, diafiltered, and concentrated to ≥ 180 g/L, then the retentate was collected. Capto S mpAct Capto S ReadyToProcess Adsorber S PreDictor apto EX Polishing Screening PreDictor apto EX olishing Screening Capto mpRes Capto ReadyToProcess dsorber PreDictor apto EX olishing Screening PreDictor apto EX olishing Screening. Before permanent installation, test the equipment with the chemicals and under the specific conditions of your application. Analysis showed that the Capto S run removed the excipients with yields of ≥ 96%. The information in this chart has been supplied to Cole-Parmer by other reputable sources and is to be used ONLY as a guide in selecting equipment for appropriate chemical compatibility. In addition, Capto S has lower resin costs, takes less time to process, and uses milder elution conditions. A Capto S column was chosen over Protein A chromatography to remove excipients from formulated drug substance because of its higher binding capacity. Fortunately, a sufficient supply of formulated DS was available for reprocessing. For example, solvent compatibility of cellulose esters is strongly dependent upon their degree of substitution (acetylation/nitration). The medium has a polymer-grafted ligand composed of a mix of two different building blocks, a. Efficient aggregate removal at high load of monoclonal antibodies. Capto S ImpAct is a strong cation exchange (CIEX) medium. High binding capacity, > 100 mg mAb/mL resin. Since the pilot plants were not available for large-scale campaigns, a creative alternative was needed to produce 2 kg of antibody from formulated DS for these studies. With a high binding capacity and small particle size, Capto S ImpAct is a good choice for reliable and robust polishing steps in an industrial purification process. Changes to the data can be made without notification. Harmsco does not assume liability for the accuracy and/or completeness of this data. The data within has been obtained from many sources and is considered to be accurate. During process scale-up, the project team decided to make a high-concentration mAb drug substance for subcutaneous injection and change the formulation. Chemical Compatibility Chart Note: This publication is to be used as a guide. The scope of this work is two-fold: 1) excipients removal from formulated mAb drug substance by Capto S chromatography and 2) UF/DF process development to make high-concentration drug substance (DS) for subcutaneous injection.
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