CCzorb-PGH4® sterile, purified styrene-divinylbenzene polymeric resins and cartridges, suitable for removal of detergents particularly during vaccine production and for Hydrophobic Interaction Chromatography
Description
Application examples
- Removal of detergents used in pharmaceutical processes (vaccine industry)
- Isolation, purification and/or concentration of hydrophobic compounds, phenolic organics, pesticides and Polycyclic Aromatic Hydrocarbons (PAHs) during manufacturing of natural plant products and extracts
- Purification of water-soluble amino acids, polypeptides and proteins (e.g., nisin)
- Removal of bitter components from fruit juices
- Reconstitution of phospholipid structures (e.g. formation of membranes, liposomes and virosomes)
Advantages
- Resistance to all commonly used organic solvents
- Applicable in a broad pH-range
- Increased capacity for increased performance
- White, soluble beads can be supplied in special package; packaging can be tailored on request
Properties
| Typical Properties These properties are typical but do not constitute specifications. |
|
| Matrix | Macroreticular crosslinked aromatic polymer styrene/divinylbenzene |
| Physical form | White translucent beads |
| Specific gravity | 1.02 |
| Harmonic mean size average | 0.6 mm |
| Mean pore diameter | 40 Ǻ |
| Surface area | > 725 m2/g |
| Porosity | > 0.50 mL/mL |
Application example
Purification of COVID-19 Corona virus membrane proteins by detergents and hydrophobic beads
In the production of vaccines also (in the context of COVID-19), detergents are used to solubilize membrane (spike) proteins. For subsequent detergent removal, sterile, ready-to-use, hydrophobic beads of CCzorb-PGH4® are an efficient tool enabling formation of antigen presenting nanoparticles.
In general, CCzorb-PGH4® particles are useful in applications that require detergent removal when the critical micelle concentration (CMC) is low and traditional purification methods are insufficient. Next to the purification of vaccines, applications of CCzorb-PGH4® therefore include the purification of hydrophobic membrane proteins as well as the removal / inactivation of viruses.
Product Specifications
The release specifications for the Product CCzorb-PGH4® are defined in CC-SP-2015.567.
Table 5
| Compound name | CCzorb-PGH4® |
| Packaging | 2L polycorbonate USP class VI bottle (Polymeric resin is suspended in phosphate buffered saline (PBS) and packed in 2-Liter polycarbonate USP class VI bottles) |
| Storage Conditions | 2 – 25 °C |
Table 6
| 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 |
| Sterility | Ph. Eur. 2.6.1 | No growth |
| Cytotoxicity3 | USP <87> | ≤ grade 2 |
| Detergent Binding Capacity | In house methode, CTAB4 binding assay1 |
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 On request
- 4 CTAB = Cetyltrimethylammonium Bromide
CTAB Binding Capacity
The binding capacity of CTAB of CCzorb-PGH4® will be tested before use of a new batch of raw material polymeric resins: the result of residual CTAB concentration should meet the requirement ≤ 100 μg/mL.
Test Methods
Tests will be performed using the approved analytical methods specified in the batch records and the specification.
Purification in Process Control
During the manufacturing process of CCzorb-PGH4®, various solvents are used to clean the resin and remove organic and non-organic contamination. Residual solvent levels will be tested. This ensures that the final product is always >20x under the level of the ICH-Q3 (5000 ppm). Residual solvent testing will be part of the regular manufacturing process.
Each batch will be tested for extractables on monomeric divinylbenzene content and Total Organic Carbon extractable level.
Residue Statements
Following statements will be supplied with each batch:
a) A BSE/TSE statement (integrated in the CoA).
b) Residual Solvents: the product is tested on residual solvent and total chromatographable organics. Results are on the Certificate of Analysis of each batch. (integrated in the CoA)
