1If MabXpure is a prefilled device what is the integrity criteria to ensure reproducibility if there are no stringent asymmetry or packing criteria?

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.

2When using MabXpure, which mechanism of action is more predominant for HCP removal, Static or Dynamic conditions?

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.

3What are the loading conditions if the MabXpure resin is packed like a column to operate under dynamic conditions? Is this still based on mix ratios?

MabXpure loading conditions can be computed by using static performance and different iterations of contact ratio, flow rate and contact time.

4Can we define MabXpure resin performance with respect to capacity of bioburden/virus removal?

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.

5How does MabXpure perform under conditions of low conductivity as it shows HCP removal reduces with increased conductivity?

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.


1Does Daicel supply an RSF for regulatory support during use and application of the product for cGMP and clinical manufacturing?

Yes, a Regulatory Support File (RSF) is available for manufacturing and regulatory support.

2What support could DAICEL offer for clinical studies for biosimilars, which may go directly from Phase 1 to Phase 3 for expedited development, to ensure product availability for large scale manufacturing using MabXpure for platform purification?

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.

3What sort of quality documentation will be available, apart from CoA, to support product quality attributes from a regulatory perspective and use in cGMP environment?

The necessary support collateral like CoA, MSDS, RSF, Extractables data and Operational protocols are all available for full manufacturing support.

4Can you provide more information and details on the modified silica and raw material specifications of the material construction used in MabXpure?

All details of materials of construction for MabXpure are provided in the RSF.

5Is Daicel able to guarantee lot-to-lot consistency with relevant acceptance criteria?

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.

6Traditional Silica based resins have low caustic resistance. How does MabXpure achieve high caustic resistance?

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.

7What leachables study have we done so far for extreme conditions and contact with 0.5 M NaOH?

Please refer to the extractables data and regulatory support file for more information.

SCM – Supply Chain

1What is the largest volume of prefilled options and bulk you can provide for the MabXpure resin?

Currently the prepacked sizes are available as standard for up to 1.5L volumes. Larger volumes can be produced on request.

2What will be the quantities at which MabXpure will be available? Are there any restrictions?

There is no major restriction of scales of operation for MabXpure since it is also available as a bulk resin.

3How do you ensure the security of supply if we decide to go to manufacturing using the MabXpure purification platform?

Daicel ensures a secure, reliable supply by dealing with qualified raw material vendors and ensuring dual manufacturing support and security of supply of MabXpure.


1Where can I find pricing on larger quantities?

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.

2Where do you manufacture MabXpure and where is my order shipping from?

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.

3Has MabXpure been tested against the extended exposure of sodium hydroxide considering it is silica-based and is ok for a longer CIP operation for a continuous process?

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.

4Can the MabXpure resin be regenerated for reuse?

At this time, no specific conditions have been determined for effective regeneration and reuse so it is a disposable/single-use product.

5If regeneration and reuse are not possible, how do we ensure batch continuity or continuous processing with MabXpure?

A replacement prepacked device will always be available ensuring continuous processing of the batch.

6Can the impurities which are bound to the MabXpure resin be quantified by recovering through elution if the characterization of impurities is required in the dynamic mode?

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.

7What is the packing density of the modified silica in the prepacked devices considering the compression factors of Silica?

The packing density of silica is quite low and lower compression factors ensure faster flow through processing and higher flow rate.

8Can the SEC displacement effect be used for small sized molecules through dynamic mode and can it be used for aggregate removal?

Yes, the displacement effect is observed after 15-20 CVs of product feed through the prepacked MabXpure device.

9For the SEC, what should be feed loading conditions of the product i.e., specifically in terms of loading density, concentration etc., if there are any?

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.

10Has any performance comparison study been done for MabXpure with existing resins, multimodal SEC or AEX or other products like chromatographic membranes?

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.

11Can MabXpure help clear Protein A leached into the drug substance intermediates?

It could be possible to remove Protein A leachates within the product. Studies are underway to prove its capability for removal.

12Can MabXpure be economical when it is used in multiple stages of the process? If MabXpure is single use then how would the economics work during a continuous process?

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.

13During MabXpure usage in flow-through mode, is there a need to filter and degas the buffers prepared in the laboratory?

It is good laboratory practice to filter and degas all buffers.

14Is there a need to pre-filter the sample feed before loading it on to the MabXpure prepacked device?

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).

15What is the binding capacity of the MabXpure FT ready-to-use cartridges?

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.

16How should I prepare my sample for loading onto the MabXpure prepacked FT device?

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).

17Do I need to control the salt concentration and pH during SEC-AEX chromatography?

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.