BioPro SmartSep. Benefits of using BioPro SmartSep. Product information

Transcription

1 Product information IEX media are widely used in the analysis and purification of biomolecules. For instance, in industrial-scale protein production processes, IEX media are often used for initial product capture and intermediate purification. resins with a 75 µm particle size are especially suited for the initial capture step unless the 10 µm, 20 µm and 30 µm are the ideal choices for the intermediate purification and polishing processes. With its small particle size, 10 µm provides extraordinary high resolution. S30 particles Benefits of using High dynamic binding capacity and recovery High resolution, 10 µm particle size material available Easy elution of target compounds Low backpressure Short delivery time for industrial-scale quantities page 1/7

2 High sample loadability media show higher dynamic binding capacity (DBC) at high flow rates in comparison to competitors products. The processing time is therefore reduced while the sample throughput can be increased at the same time. An example of the performance of the S30 in the purification of lysozyme and insulin is shown below (Figure 1 and figure2). Conditions (Lysozyme) Equilibration buffer: 20 mm Glycine-NaOH (ph 9.0) Elution buffer: 20 mm Glycine-NaOH (ph 9.0) cont. 0.5M NaOH Linear velocity: 400 cm/hr (1.32 ml/min) Lysozyme Conditions (Insulin) Equilibration buffer: 20 mm Citric acid-tri sodium citrate(ph 3.5) / 20% IPA Elution buffer: 20 mm Citric acid-tri sodium citrate(ph 3.5) / 20% IPA cont. 0.3 M Sodium sulphate Linear velocity: 400 cm/hr (1.32 ml/min) Insulin Fig. 1: Comparison of DBC of S30 and competitors materials for Lysozyme and Insulin purification. Conditions Equilibration buffer: 20 mm Glycine-NaOH (ph 9.0) Linear velocity: cm/hr (0.66 ml/min-3.27 ml/min)) Lysozyme Fig. 2: Dynamic Binding Capacity of Lysozyme at different flow rates. page 2/7

3 Low backpressure media demonstrate lower backpressures compared to competitors materials over a wide range of flow rates (figure 3). Less than 1 MPa (10 bar) backpressure is generated with a bed length of 250 mm. Equilibration buffer: 20 mm Glycine-NaOH (ph 9.0) Linear velocity: cm/hr (0.66 ml/min-3.27 ml/min) Lysozyme = = TSK = GE Linear flow rate (cm/hr) Fig. 3: Correlation between flow rates, bed length and backpressure. The narrow particle distribution and controlled pore size lead to constant high performance and highly efficient packed columns. page 3/7

4 High resolution, excellent recovery and easy elution of target compounds In addition the high resolution and excellent recovery features, another highlight of media is the easy elution of target compounds. High efficiency and productivity can be achieved even with challenging separations. Recovery (> 98% Purity) Ribonuclease A Cytochrome c Lysozyme Total S % 81.5% 99.3% 90.7% TSKgel SP-3PW 74.2 % 54.4 % 99.5 % 76.9 % GE Source 30S 87.2 % 76.0 % 99.5 % 87.8 % Fig. 4: Comparison of resolution with competitors materials. Eluent: A) 20 mm NaH 2 PO 4 -Na 2 HPO 4 (ph 6.8) B) 20 mm NaH 2 PO 4 -Na 2 HPO 4 (ph 6.8) cont. 0.5 M NaCl 0-100% B, 30 column volumes Flow rate: 1600 cm/hr (5.23 ml/min) Temperature: 25 C Detection: UV at 220 nm Injection: 20 ml (30 mg Proteins) 1. Ribonuclease A (0.5 mg/ml) 2. Cytochrome c (0.5 mg/ml) 3. Lysozyme (0.5 mg/ml) resins are also compatible with alkaline cleaning in place (CIP) procedures. This therefore ensures a constant high performance and a long lifetime for the resins. page 4/7

5 Conclusions bulk media offer a perfect solution for challenging separations. With the high binding capacity and high recovery, the media allow high-throughput purifications, increased productivity and reduced costs. The easy elution of target also makes the whole process easier. Three available particle sizes, 10 µm, 20 µm and 30 µm, are especially suited for the intermediate purification and polishing steps of biomolecules. media provide: Solution for challenging separations Increased productivity Reduced processing costs Worldwide availability, even for large quantities Full compliance with FDA regulations page 5/7

6 Product Range for intermediate purifications and polishing Series Q10 Q20 Q30 S10 S20 S30 Ion exchange type strong anion exchanger strong cation exchanger Charged group -R-N + (CH 3 ) 3 -R-SO 3 - Matrix Pore size Hydrophilic polymer beads Porous Compression factor Particle size 10 µm 20 µm 30 µm 10 µm 20 µm 30 µm Pressure resistance 3 MPa Max.: 4 MPa 2 MPa Max.: 3 MPa 3 MPa Max.: 4 MPa 2 MPa Max.: 3 MPa Ion-exchange capacitiy min meq/ml-resin min meq/ml-resin Dynamic binding capacity min. 100 mg/ml-resin (BSA) min. 100 mg/ml-resin (lysozyme) YMC- for Capture Series Q75 S75 Ion exchange type strong anion exchanger strong cation exchanger Charged group -R-N + (CH 3 ) 3 -R-SO 3 - Matrix Pore size Hydrophilic polymer beads Porous Compression factor Particle size 75 µm Pressure resistance Ion-exchange capacitiy Dynamic binding capacity 0.3 MPa min meq/ml-resin min. 160 mg/ml-resin (BSA) Regulatory support file available under non-disclosure agreement. Used in validated cgmp-manufacturing processes. Customized material available on request. DMF registered with FDA. page 6/7

7 Availability A large production capacity of the YMC s IEX media is available. The batch size is up to 500 L. Strong anion exchanger: Q Product Particle Size Code Pack Sizes* 50 ml 250 ml 1 L 5 L 10 L 20 L Q10 10 µm QSA0S10 Q20 20 µm QSA0S20 Q30** 30 µm QSA0S30 Q75 75 µm QAA0S75 Strong cation exchanger: S Product Particle Pack Sizes* Code Size 50 ml 250 ml 1 L 5 L 10 L 20 L S10 10 µm SSA0S10 S20 20 µm SSA0S20 S30** 30 µm SSA0S30 S75 75 µm SPA0S75 * Larger or customised pack sizes are available on request. ** Conventional Q30/S30 (QAA0S30/SPA0S30) available on request. Screening Kits YMC offers a number of ion exchange screening kits based on 1 ml or 5 ml columns for laboratory scale screening and method development. 1 ml Type (26 x 7.0 mm ID) Resin screening Purification method development 5 ml Type (26 x 15.6 mm ID) Purification method development Loadability studies page 7/7