MediaScout® MaxiChromAC

PrePacked Process Columns

Disposable-GMP-pre-packed-process-scale-columns

Instruction Manual

Application Notes

MediaScout® MaxiChromAC columns are ready-to-use and pre-qualified process chromatography columns available pre-packed with almost any commercial chromatography media based on soft e.g. Agarose, or semi-rigid e.g. PMMA polymeric backbone.

MaxiChromAC columns are designed for the purification of biopharmaceutical compounds such as mAbs and completely made of polymeric materials which allows easy disposal after usage.
As a result of this disposable design, MediaScout® MaxiChromAC columns can be used in single-use production workflows for preclinical, clinical phase I and II studies as well as for full-scale manufacturing depending on scale and titer of the corresponding fermentation process.
 
Apart from the omission of cleaning and cleaning validation the usage of pre-packed MaxiChromAC process columns provides the following benefits:
 
  • Time and cost savings by outsourcing column packing and packing evaluation
  • Process security due to reproducible column performance
  • Reduced protein A resin costs by running multiple chromatography cycles
  • No cross-contamination problems
 
MaxiChromAC process columns are part of the MediaScout® platform from Atoll, including innovative downstream process development tools and pre-packed ValiChrom columns for accurate down-scale modelling and virus validation purposes.

MaxiChromAC columns are available in 3 standard dimensions and manufactured to a fixed bed height of 200 mm to ensure optimum residence time, flow and capacity for your chromatographic media/operation. 
Customised and alternative bed heights between 100 and 200 mm are available on request.
 

MaxiChromAC characteristics

Inner diameter 100 mm 200 mm 300 mm
Packed bed height 200 mm 200 mm 200 mm
Column volume 1.6 L 6.3 L 14.1 L
Inner cross section 79 cm2 314 cm2 707 cm2
Outer diameter incl. lid 200 mm 310 mm 460 mm
Outer height 465 mm 465 mm 486 mm
Weight ~ 7 kg ~ 20 kg ~ 47 kg
Net mesh 8 µm 8 µm 8 µm
Connectors TC25 TC25 TC25
Tubing inner diameter 6.3 mm (0.25’’) 9.5 mm (0.375’’) 9.5 mm (0.375’’)
Chemical stability All commonly used aqueous buffers, pH 1 – 14, organic solvents1, 2
Avoid Halogenated organic solvents, hexane
Storage solution
  • AIEX and CIEX: 20 % ethanol + 150 mM sodium chloride
  • HIC, SEC, AC and MMC: 20 % ethanol
  • HyperCel™ (PALL): 30 % isopropanol + 0.1 M sodium phosphate, pH 4.3
Recommended storage
temperature
  • AIEX, CIEX, HIC, SEC and MMC: +4°C to +30°C
  • AC: +4°C to +8°C
Working temperature +4°C to +30°C
Max. working pressure                    Up to 6.0 bar

1 Note: The chemical stability of the packed chromatography media has also to be taken into consideration. For more information
  please refer to the manufacture’s resin specification.

2 Do not apply organic solvents e.g. ethanol, isopropanol diluted in water in higher concentration than 30%. 

 
MaxiChrom columns are packed in Class C clean-room environment using standard operation/packing procedures and are available Standard and AC = Atoll Certified containing the following product documentation package:
MaxiChrom Disposable Column Configurations
Product Documentation Standard AC Atoll Certified
CoA showing packing performance: N/m and As
CoA showing pressure flow rate characteristics
CoA showing individual column Endotoxin and Bioburden results  
CoC showing wetted materials are in conformance with USP Class VI, FDA 21 CFR and free of animal origin (ADI)  
Raw Material Tracking Sheet  
Individual column Endotoxin and Bioburden results for cleaning of column components  
Resin Tracking Sheet  
Buffer Tracking Sheet