Functionality
Integrity criteria is provided in the Certificate of Analysis (CoA). Please refer to the CoA for the MabXpure prepacked FT device and MabXpure bulk. Unlike conventional resins, there are no stringent packing criteria for asymmetry and HETP.
HCP removal occurs in both mechanisms due to high selectivity of the AEX ligand which targets the purification of mAbs in flow-through mode due to the size exclusion of the pores, trapping the most prominent co-eluted HCPs which could make their way with the process feed.
MabXpure loading conditions can be computed by using static performance and different iterations of contact ratio, flow rate and contact time.
We can define resin performance on Log reduction values (LRV) levels of impurity in clarification and polishing with HCPs, DNA and Viruses. LRV>3 for viruses can be claimed for midstream and DSP operations. Depending on conditions, the capacity of DAISEP MabXpure helps to remove up to 1LRV of HCP and 2 LRV of DNA in the process.
Like other AEX, MabXpure performs well in low-conductivity conditions and shows a drop in HCP clearance as conductivity is increased. 7.8 ms/cm gives very high HCP clearance.
Quality
Yes, a Regulatory Support File (RSF) is available for manufacturing and regulatory support.
All necessary support for transition from development to manufacturing will be offered as per the demand for the product. There will also be dual manufacturing sites for supply assurance.
The necessary support collateral like CoA, MSDS, RSF, Extractables data and Operational protocols are all available for full manufacturing support.
All details of materials of construction for MabXpure are provided in the RSF.
The qualitative consistency of MabXpure and its raw material is guaranteed by the CoA. We source only through qualified vendors with a long-term supply agreement and the quality of the finished product is also ensured by production in a controlled environment.
The MabXpure product has been designed in a way which minimizes the exposure of the susceptible regions of the silica bead to caustic exposure during use and hence has a good caustic resistance.
Please refer to the extractables data and regulatory support file for more information.
SCM – Supply Chain
Currently the prepacked sizes are available as standard for up to 1.5L volumes. Larger volumes can be produced on request.
There is no major restriction of scales of operation for MabXpure since it is also available as a bulk resin.
Daicel ensures a secure, reliable supply by dealing with qualified raw material vendors and ensuring dual manufacturing support and security of supply of MabXpure.
Usage
Please refer to our standard price list for products up to 1.5L volumes. For devices larger than 1.5L or for bulk resin, please contact your local sales office for pricing and availability.
The product is currently manufactured in France and will be manufactured on a larger production scale in Japan. Local offices will stock product to ensure speedy delivery.
Yes, MabXpure has been tested for caustic stability. Please refer to RSF for more information. The product is meant for single-use and is capable of handling caustic exposure for a unit operational step in the process.
At this time, no specific conditions have been determined for effective regeneration and reuse so it is a disposable/single-use product.
A replacement prepacked device will always be available ensuring continuous processing of the batch.
Yes. Some of the impurities could be possibly recovered by elution with the AEX mechanism. However, the impurity removal is mainly characterized by clearance data.
The packing density of silica is quite low and lower compression factors ensure faster flow through processing and higher flow rate.
Yes, the displacement effect is observed after 15-20 CVs of product feed through the prepacked MabXpure device.
The loading density is related to the static performance of MabXpure and striking a balance between recovery and flow rate performances. Size exclusion mechanism is similar to a filter in this case, as opposed to a conventional resin, so it does not create any bottlenecks like low flow rates, longer processing time or smaller loading.
No comparison studies have been made with other resins since this is a unique product with different performance characteristics being used in static and dynamic modes.
It could be possible to remove Protein A leachates within the product. Studies are underway to prove its capability for removal.
Pricing is very competitive since the product is quite effective in different mix ratios which reduces overall operating costs. In addition the actual cost/litre of the resin is also very competitive in comparison to conventional resins for resin-based chromatography.
It is good laboratory practice to filter and degas all buffers.
All feed samples should be filtered through a 0.2 μm syringe filter or centrifuged to remove particulates. (Note that MabXpure can also be used in combination with diatomaceous earth (D.E.) or adsorptive depth filter to remove particulates, cell debris and mAb process and product related contaminants during midstream operations or sample preparation steps).
MabXpure FT is able to bind up to 20 mg/mL of HCPs, DNA and other impurities from mAb feedstock. As it is a flow-through device, the performance is not formally characterized by its binding performance.
With the exception of 0.2 µm filtration, no further specific sample preparation is required. MabXpure is designed to be used for plug-and-play before the Protein A step or as a polishing step. Ideal sample pH range is from 5.0 to 8.0 (preferably >6.0) and ideal conductivity is <15 mS/cm. (Note: Buffer exchange can be performed using the equilibration buffers mentioned in the protocol to evaluate the impact on depletion performances, however, this is mainly recommended for midstream applications).
MabXpure is designed to work in normal physiological conditions, in flow-through mode, so the control of salt concentration and pH is not very critical.
