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Frequently Asked Questions

FIBER - AstreAdept®

What makes the AstreAdept® platform different?

AstreAdept® is a groundbreaking chromatography matrix that offers unparalleled performance in cell and gene therapy purification applications. Its unique electrospun nanofiber structure provides a large surface area coupled with an expansive flowpath, giving exceptionally high capacity and superior flow characteristics. This outstanding performance is further enhanced by a protective shell that minimizes void volume and ensures long-lasting integrity.

The application of chromatography ligands results in an ideal choice for cell and gene therapy purification. Products that incorporate AstreAdept® include our LentiHERO®, pDNAHERO® and ExoHERO® ranges.

What are the binding capacities and recovery characteristics, and flow rates for LentiHERO® products?

Both binding capacity and recovery will vary according to the feedstock, as well as upstream and mid-stream processes, as a general guide:

Suspension Lentivirus:

  • Capacity: 1.75 x 10E+12 viral particles (VP) per milliliter (mL) adsorbent, measured by p24 antigen assay.
  • Recovery: 53% of the infective LV vectors load, measured by a Jurkat transduction assay.

Adherent Lentivirus:

  • Capacity: 4.5 x 10E+11 viral particles per mL adsorbent, measured by p24 antigen assay.
  • Recovery: 54% of the infective LV vector load, measured by a Jurkat transduction assay.

Flow rates: The loading step is performed at a flow rate of 5 mL/min. However, under certain conditions, the capsule can operate at flow rates up to 10 mL/min. The optimal flow rate will depend on the specific process and feed conditions.

What are the binding capacities and recovery characteristics and flow rates for ExoHERO® products?

Both binding capacity and recovery will vary according to the feedstock, as well as upstream and mid-stream processes, as a general guide:

  • Capacity: 1.7 x 10E+12 extracellular vesicle particles per mL adsorbent.
  • Recovery: >50% of loaded particles, as measured by nanoparticle tracking analysis.

Flow rates: The loading step is performed at a flow rate of 5 mL/min. However, under certain conditions, the capsule can operate at flow rates up to 10 mL/min. The optimal flow rate will depend on the specific process and feed conditions.

 

What are the binding capacity and flow rate characteristics for pDNAHERO® polish products?

The binding capacity is 4 mg of pDNA/mL adsorbent measured by loading a pure 4.7 kb plasmid.

Flow rates: The loading step is performed at a flow rate of 5 mL/min. However, under certain conditions, the capsule can operate at flow rates up to 10 mL/min. The optimal flow rate will depend on the specific process and feed conditions.

 

Are the LentiHERO®, pDNAHERO® and ExoHERO® ranges sanitizable? What is the clean-in-place procedure?

The LentiHERO®, pDNAHERO® and ExoHERO® ranges are sanitizable with a 0.5 M NaOH solution.

These products are designed for campaign- or single batch-use, and detailed cleaning-in-place instructions are provided in the Technical User Guide to ensure thorough cleaning and optimal performance. As feedstocks and processes vary, it is recommended that the performance of this product is validated after CIP.

 

Can the LentiHERO®, pDNAHERO® polish and ExoHERO® 1 and 10 products be used with manual pumps and with FPLC systems?

The LentiHERO®1, pDNAHERO®1 polish and ExoHERO® 1 are fitted with luer connections that allowing operation with both manual pumps and FPLCs systems. Comprehensive instructions are provided in the Technical User Guide to ensure seamless integration into either system.

The larger LentiHERO®10, pDNAHERO® 10 polish and ExoHERO® 10 capsules are fitted with standard sanitary connectors suitable for application with most FPLC systems.

 

Where can I find the technical user guides for the LentiHERO®, pDNAHERO® polish and ExoHERO® products?

Link to Technical User Guides for current AstreAdept® offerings:

ExoHERO®
LentiHERO®
pDNAHERO® polish

 

COLUMNS - SNAP®, Evolve®, Evolve®D

Which resins do you pack in SNAP® Laboratory Columns?

Our column packing services enable a wide range of chromatography media to be packed into our SNAP® Laboratory Columns. We have experience with a range of matrices, including agarose and polystyrene-based beads. Contact us at techsupport@astrea-bio.com to find out how we can support your pre-packed column needs.
 

What are the pressure limits of SNAP® Laboratory Columns?

Our SNAP® Laboratory Columns exhibit exceptional pressure ratings; see the table below for the maximum pressure ratings we recommend with our hardware.

Diameter (ID)Pressure (BAR)Pressure (PSIG) 
10 mm40580 
15 mm35 508 
25 mm24 348 
35 mm18 261 
50 mm13 188 

Please refer to information provided by the resin manufacturer for recommended operating pressure of media packed in the columns.

 

What is the size of the inlet and outlet port connectors of SNAP® Laboratory Columns?

The inlet and outlet of our SNAP® Laboratory Columns are 0.065” (1.65 mm) with a 1/4“-28 female screw thread fitting. Connectors are supplied with each SNAP® olumn purchased to enable seamless connection to your chromatography system.
 

What materials are SNAP® Laboratory Columns constructed of?

SNAP® Laboratory columns are available in different materials depending on the intended application. Bio-compatibility should be verified with the material selection of column configuration. 

SNAP® Laboratory Columns are comprised of a number of components. Materials in contact with the wetted flow path vary depending on the configuration selected. 

For aqueous-based buffer processes: borosilicate glass, acetal, Viton®, and polyethylene. For solvent-based processes: borosilicate glass, PEEK, Kalrez® (or equivalent) and polyethylene or stainless steel.

 

 

 

What dimensions of SNAP® Laboratory Columns are available?

SNAP® Laboratory Columns are available in diameters of 10, 15, 25, 35, and 50 mm, with column tubes available to accommodate bed heights of up to 1000 mm.
 

What is the shelf life of an Evolve®D Column?

Evolve®D Columns from Astrea Bioseparations have a 2 year shelf life from when they are packed.

 

 

What are the pressure limits of Evolve®D Columns?

The recommended operating pressure is dependent of the characteristics of the media that is packed within the EvolveD® Column. Please refer to information to the media manufacturer. The column hardware is suitable to a maximum 4 bar operation.

Which resins do you pack in EvolveD® Columns?

Our column packing services enable a wide range of chromatography media to be packed into our Evolve®D Columns. We have experience with a range of matrices, including agarose and polystyrene-based beads. Contact us at techsupport@astrea-bio.com to find out how we can support your pre-packed column needs.

What is the size of the inlet and outlet port connectors on EvolveD® Columns?

The inlet and outlet connectors for all Evolve®D Columns are ¾” (25 mm) ladish sanitary tri-clamp fittings. The diameter of the flow path varies with column diameter; 7 cm and 10 cm diameter columns have a 3 mm flow path, whereas 14 cm and 20 cm columns have a 6 mm flow path.
 

What materials are Evolve®D Columns constructed of?

The main materials of construction of the Evolve®D Columns which are in contact with the process flow path are polypropylene, 20% glass-filled polypropylene, Santoprene®, and EPDM. 

Materials of construction external to the process flow path are acetal, polypropylene, 316 stainless steel, nylon, glass-filled polypropylene and EPDM.

 

What dimensions of Evolve®D Columns are available?

The Evolve®D Column range offers column diameters of 7, 10, 14, and 20 cm, and bed heights of 5, 10, 15, and 20 cm.
 

What are the pressure limits of Evolve® Process Columns?

Evolve® Process Columns have a maximum operational pressure rating up to 4 bar, with the exception of the 45 cm diameter column (2.5 bar) and the 60 cm diameter column (3 bar). 
 

What is the size of the inlet and outlet port connectors of Evolve® Process Columns?

The inlet and outlet connectors for all Evolve® Process Columns are ¾” (25 mm) ladish sanitary tri-clamp fittings. The diameter of the flow path varies with column diameter; 7 cm and 10 cm diameter columns have a 3 mm flow path, 14 cm, 20 cm and 25 mm columns have a 6 mm flow path, 35 cm and 45 cm columns have a 10 mm flow path, and 60 cm columns have a 14 mm flow path.
 

What materials are the Evolve® Process Columns constructed of?

The main materials of construction of the Evolve® Process Columns which are in contact with the process flow path are acrylic, polypropylene, 20% glass-filled polypropylene, Santoprene®, and EPDM.  Materials of construction external to the process flow path are acetal, 316 stainless steel, nylon, glass-filled polypropylene, PTFE, and EPDM.
 

What Evolve® Process Column diameters are available?

Our Evolve® Process Columns are available in diameters of 7, 10, 14, 20, 25, 35, 45, and 60 cm

 

What tube heights are available for Evolve® Process Columns?

The Evolve® Process Column tube heights range from 52 cm for the 7-25 cm diameter columns, 50 cm for the 35 cm column, 48 cm for the 45 cm column and 46 cm for the 60 cm column. Note that this is not the maximum achievable bed height for the columns; maximum achievable bed heights will depend on the media being packed and the packing method. Evolve® Process Columns are ideally suited to bed heights of up to approximately 30 – 35 cm.

What parts come in an Evolve® Refresh Kit?

Components that are in contact with process fluids during normal operation procedures are provided in a single convenient kit. Evolve®  Refresh Kits include the acrylic tube & scale label, adjuster & bottom flow tubes, flow tube seals, pipe spool elbow, adjuster seal, sanitary clamp adapter, adjuster bed support assembly, bottom bed support assembly, top & bottom buffer seals, adjuster flow cell, bottom flow cell & anti jets. A detailed manual is provided to assist the procedure.

RESINS

What are the required resin storage conditions?

20% ethanol/ 20% ethanol containing 0.1M NaCl, depending on the ligand (please consult our User Guides).
 

What base bead is used for the Astrea Bioseparations resin products?

The majority of the Astrea Bioseparations resins are based on PuraBead® 6HF or PuraBead® 6XL, near mono disperse agarose beads which are manufactured in-house. (Exceptions being p-Aminobenzamidine A6XL and IsoClear® A and B).
 

What is the particle size of PuraBead® HF?

~90 µm bead size.
 
 

Are your resins stable in NaOH?

Yes, the resins can be cleaned using 0.5- 1.0M NaOH. (Exceptions being p-Aminobenzamidine A6XL and IsoClear A and B).
 

Can your resins be reused multiple times?

Yes, with an optimized process that includes cleaning, 100+ cycles can be achieved.
 
 

What is the recommended maximum operating pressure for our resins?

We recommend packing at up to 3 bar with an operating pressure of ≤ 70% of the packing pressure, therefore 2.25 bar is the maximum recommended operating pressure.
 

Are there any buffers or additives that are unsuitable to use with our resins?

In most cases the majority of commonly used buffers and additives can be used with our resins. Consult our User Guides or contact techsupport@astrea-bio.com for any specific questions. 
 
 
 
 

What pH range are your resins stable within?

Generally pH 2 - 14. Below pH 2 will degrade the agarose beads. (Exceptions are p-Aminobenzamidine A6XL and IsoClear A and B which are unstable at high pH).
 
 

What is the dynamic binding capacity?

This varies from product to product and with conditions of use. Consult the User guide for specific examples of binding capacities of the resins. Where that information is not available, contact techsupport@astrea-bio.com
 

What is the optimum residence time for your resins?

This varies from product to product but in general we state between 3 and 5 minutes residence time.
 

What is the difference between PuraBead® XL & PuraBead® HF?

They differ in the cross linking chemistry, with HF having higher flow properties. Both agarose beads are manufactured by Astrea Bioseparations and are approximately the same size, 90-100µm. 
 
 
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