FabRICATOR®
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FabRICATOR® Validation Kit
Three different lyophilized batches for validation of FabRICATOR-based analytical methods
FabRICATOR (IdeS) is an IgG-specific cysteine protease that digests antibodies at a single amino acid site below the hinge, generating homogenous F(ab’)2 and Fc fragments.
The FabRICATOR (IdeS) enzyme has become a widely used tool in the biopharmaceutical industry for characterizing monoclonal antibodies, Fc-fusion proteins, ADCs and biosimilars for therapeutic use.Each batch of the FabRICATOR enzyme is rigorously tested for enzymatic activity, identity and purity before it is released. The FabRICATOR Validation Kit consists of three batches of the lyophilized enzyme, to make the method validation easier. A certificate of analysis is included with each batch.
Why FabRICATOR® Validation Kit?
- Simplified method validation for QC applications
- Ideal format for batch-to-batch variability assessment
- Increased confidence in performance of batch release assays
Available Products
FabRICATOR® Validation kit 3 x 2000 units
Three different lyophilized batches for validation of FabRICATOR-based analytical methods
For information on how to order, visit Place an Order or contact us directly at order@genovis.com.
Product Information
Unit Defintion
One unit digests ≥ 95% of 1µg human IgG when incubated in 10 mM sodium phosphate, 137 mM NaCl, 2.7 mM KCl pH 7.4 at 37°C for 30 min.
Buffers
The buffers below have been tested for compatibility with FabRICATOR digestion at different pH. Note that the FabRICATOR enzyme is irreversibly inactivated below pH 5.0. Digestion above pH 8.0 requires prolonged/optimized conditions.
- Phosphate buffer saline (PBS) 6.0 – 8.0
- Tris buffer 7.0 – 8.0
- MES buffer 5.5 – 6.5
- HEPES buffer 7.0 – 8.0
- Ammonium bicarbonate buffer 6.0 – 7.0
- Sodium acetate buffer 6.0
Content and Storage
FabRICATOR Validation Kit consists of three different lyophilized batches of the FabRICATOR Lyophilized enzyme. The enzymes are reconstituted by addition of water. No preservatives added. After reconstitution, FabRICATOR is stable for 1 month at +4-8°C. The product is shipped at ambient temperature, and should be stored at -20°C upon arrival.
Resources
Instruction for Use
Product Specifications
Safety Data Sheet
Certificate of Analysis
Find your certificate of analysis »FAQ and Support
Can I use FabRICATOR (IdeS) with very low amounts of IgG?
It is possible to use FabRICATOR with low concentrations of IgG. Low concentrations of IgG will lead to decreased reaction rate, so for concentrations below 0.5mg/mL it is therefore recommended to increase the amount of added enzyme and/or increase the incubation time. There is no risk of over-digestion and the incubation time can be prolonged to O/N if necessary.
Does FabRICATOR introduce modifications?
FabRICATOR is a cysteine protease. It should not result in any other modifications than the digestion of the peptide bond. Digestion will be between the two Glycines (…CPAPELLG / GPSVF…) and the C-terminus will regain the carboxyl group – that is addition of one OH-group and the N-terminal amino group will be regained (addition of one H).
In summary, R1-CO-NH-R2 + H2O –> R1-COOH + NH2-R2.
I have a small modification in the sequence below the hinge, will FabRICATOR still digest my IgG?
FabRICATOR is a very specific enzyme and small changes in the sequence in or around the digestion site (…CPAPELLG / GPSVF…) may reduce or completely impair the ability to digest the IgG. It is very difficult to predict the outcome for each specific modification. It might work, but we cannot guarantee it unfortunately, the only way of knowing is to perform a digestion test. Some suggestions that are worth testing if you experience incomplete digestion: Increase the incubation time, increase the amount of added enzyme, use a PBS with greatly reduced salt concentration (5-10 mM instead of 140 mM) and pH 6.5 instead of 7.4.
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