The sterile, ready-to-use CCzorb® products of Ardena LSI are of use in isolation, purification, concentration, catalyzation and re-constitution of nutritional and pharmaceutical compounds.
Within the CCzorb® line, resins for chromatography or batch wise use are available for hydrophobic or ionic interactions.
Description
For their use in high-quality and sensitive applications such as pharmaceutical and biological processes, CCzorb® products have been treated and purified in line with cGMP requirements to remove undesired monomeric and oligomeric compounds. After the cleaning and purification process, the resin is equilibrated in an application specific buffer solution (e.g., phosphate buffered saline solution). The resulting increased adsorption capacity of CCzorb® products leads to a higher purity of the end product, thereby minimizing losses.
For vaccine production, especially in connection with COVID-19 and Influenza vaccines, products of the CCzorb® line are advantageous for the encapsulation of mRNA into liposomes by the detergent removal technique and for the isolation and purification process of membrane proteins.
Further areas of use include water softening, polishing, chelation, acidification, neutralization, de-colorization and deodorization of (nutritional) products.
CCzorb® products are supplied in sterile, ready-to-use 2L bottles so that they can be transferred directly to a reactor, which makes the application considerably easier.
The CCzorb® product line consists of the following resins:
- – CCzorb-PGH4®
- – CCzorb-PGH16®
- – CCzorb-PGH7®
- – CCzorb-PGA9®
- – CCzorb-PGC3®
- – Customized resins: We have the capabilities and expertise to develop & manufacture other resins upon your request. To discuss this, get in touch with our experts here.
| Test | Method | Acceptance Criterion |
| Appearance | Visual | Light-yellow globules |
| Volume | Visual | 1600 mL sedimented resin in a total of 2000 mL |
| Residual solvent | GC-Headspace | < 0.25% m/m |
| Total Chromatographable Organics (TCO) | GC-FID1 | < 10 ppm (μg/g) |
| Divinylbenzene (DVB) by UPLC | UPLC2 | <50 ppb (ng/mL) |
| pH of solution | Ph. Eur. 2.2.3 | 6.9 – 7.6 |
| Endotoxins | Ph. Eur. 2.6.14 | < 5 IU/mL Negative controls negative |
| Sterility | Ph. Eur. 2.6.1 | No growth |
| Cytotoxicity4 | USP <87> | ≤ grade 2 |
| Detergent Binding Capacity | In house method,
CTAB3 binding capacity1 | Removal of > 110 mg CTAB/mL resin (residual concentration < 100 μg/mL) |
- 1 The TCO method is a modified method of EPA SW-846, method 0010, Appendix B
- 2 DVB testing according to CFR 21:173.65
- 3 CTAB = Cetyltrimethylammonium Bromide
- 4 On request