- Industry- accepted, in 3 commercial processes and an expanding pipeline of Phase 1-3 processes
- High dynamic binding capacity, 30-40 mgs / ml
- Low Protein A leaching, less than 10 ng/mg IgG
- Cost-efficient, one-third the cost of traditional resins, increased savings when pre-packed into OPUS® columns
- Secure supply
CaptivA® Protein A Affinity Resin combines an industry standard cross-linked agarose bead with recombinant native Staphylococcal Protein A (rSPA) manufactured by Repligen, the world’s leading manufacturer of recombinant Protein A.
|
Base Matrix |
Particle Size |
|
|
4% highly cross-linked agarose bead |
45-165 μm |
Ligand
- Recombinant native Staphylococcus Protein A (rSPA) expressed in E.coli
- Recombinant form equivalent to the native Protein A form
- Contains all five immunoglobin binding domains (E,D,A,B,C)
- Coupling via reductive amination provides multi-point attachment
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, and ensuring business continuity for our customers.
Performance
Dynamic Binding Capacity
44 mg hIgG/ mL at 6 min residence time
Protein A Leaching
< 10 ng/mg IgG
Caustic Stability
100 cycles with 0.1M NaOH
Recommended Flow Velocity
30-300 cm/hr
Recommended pH and Temperature Stability
Working: 3-10
Cleaning-in-Place: 2-11
Temperature Stability: 4-40 C
High dynamic binding capacity
CaptivA® Protein A Affinity Resin delivers high dynamic binding capacity at standard process flow rates and residence times.
Dynamic binding capacity was determined for human polyclonal IgG at four different flow velocities providing residence times ranging from 0.5 to 6 minutes. A 5 x 50 mm column was loaded with a 2 mg/ml hIgG solution in PBS pH 7.4. Capacity was determined and reported at 2, 5, and 10% breakthrough. A column bed height between 10-20 cm, loaded at 200 cm/hr provides 6-12 minutes of residence time.
Sanitization stability
CaptivA® Protein A Affinity Resin retains desired dynamic binding capacity when exposed to stringent washing conditions that reduce standard feed stream contaminants. The CaptivA® recombinant Protein A attachment mechanism creates multiple covalent attachment points between the ligand and agarose bead resulting in superior alkali resistance compared to single point attachment chemistries.
The human polyclonal IgG dynamic binding capacity was determined following 0.1 N NaOH exposure. A 5 x 50mm column was loaded with a 2 mg/ml hIgG solution in PBS pH 7.4. The loading residence time was 3 minutes. Capacity was determined and reported at 2% breakthrough. After elution, the column was exposed to 0.1 N NaOH for 5 hours. Five cycles were completed. An exposure time of 25 hours represents 100 x 15 minute CIP cycles.
Low Protein A leaching
CaptivA® Protein A Affinity Resin multi-point protein chemistry consistently delivers low Protein A leaching.
The human polyclonal IgG binding capacity was determined following each column cycle. Cleaning was performed between cycles with either extra volumes of Glycine pH 3.0 elution buffer or 0.1 N NaOH with a 15 minute contact time. Leached Protein A was measured in the product elution pool from each cycle using the Repligen Protein A ELISA Kit. Protein A leaching from CaptivA® Protein A Resin is consistently
CaptivA® Protein A Affinity Resin is the most cost-effective chromatography resin available today, delivering industry standard performance at a fraction of the cost of traditional affinity resins, especially when pre-packed into OPUS® chromatography columns.
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