POROS® GoPure™ for Process Validation
GoPure™ prepacked columns: facilitating process development and validation efficiency
Biotherapeutic purification process development requires numerous levels of process validation as projects move through clinical development. These validation activities include:
- Scale-down process validation
- Viral clearance validation
- Resin reuse validation
- Resin cleaning validation
- Impurity clearance validation
- Process robustness assessment
- End-of-production assessment
- Resin storage stability
In addition, quality-by-design concepts can be employed during process development and definition.
All of these purification process development and validation activities require the use of lab-scale chromatography columns packed with the resin under investigation. Each process characterization activity requires multiple chromatography columns to be packed to required specifications. Significant resources, including people, time, and equipment, are required to prepare columns for process development and validation activities.
A single viral clearance validation study can consume tens of packed columns, requiring hardware that will not be reused and multiple weeks of column packing and qualification activities. Very quickly, the number of lab-scale columns required to support early- and late-phase process development and validation accumulates. Ultimately, the column packing and qualification required is a low-value-added activity centered on preparing a critical raw material for high-value, critical-path experiments.
GoPure™ 1.2 cmD prepacked chromatography columns provide a convenient and cost-effective alternative to self-packed columns. They offer a time-saving alternative to column-packing activities required to support process definition and validation studies.
GoPure™ column and product quality features that are relevant to the scale-down process model include:
- Manufacturable with any chromatography resin
- Flexible in column bed heights
- Reproducible packed column performance
- Representative of pilot- and manufacturing-scale column performance
- Scalable performance across the entire GoPure™ column size range
- Offering a business process with user-specific product definition and resin traceability
Flexibility and quality
GoPure™ 1.2 cmD columns are available in a range of bed heights from 5 to 20 cmL. GoPure™ columns are packed using validated processes. Packing is based on traditional flow and axial compression, allowing for control of the final bed height that is ±3 mm from the target bed height. All columns are qualified and meet asymmetry, plates-per-meter, and permeability specifications.
Figures 1 and 2 show column qualification results across GoPure™ 1.2, 8.0, and 20 cmD columns for POROS® HS50 and an Agarose Protein A resin. The results show consistent and equivalent column performance across the entire product range, indicating that GoPure™ 1.2 cmD columns are an effective format for a scale-down model and are therefore well suited for use in process validation studies.
Asymmetry specifications for all columns were 0.80 –1.60. The qualification test results, generated on separate chromatography instruments, are consistent across all column diameters.
POROS® GoPure™ columns have an efficiency specification of ≥4,000 plates per meter, and Agarose Protein A GoPure™ columns have an efficiency specification of ≥ 2,000 plates per meter. Efficiency values are consistent with resin vendor claims.
Figure 3 demonstrates equivalent performance between a GoPure™ 1.2cmD prepacked column and a self-packed laboratory column. Qualification results, in the upper panel, and protein separation results, in the lower panel, are virtually identical between the 1.2 cmD x 10 cmL GoPure™ XS prepacked column and the traditional 1.0 cmD x 10 cmL laboratory column packed with POROS® XS resin.
Manufacturing data from GoPure™ 1.2 cmD columns, detailed in Table 1, demonstrate product reproducibility within and between lots. Within-lot variability in column efficiency (plates per meter) and asymmetry is typically less than 10%, independent of the resin type or date of manufacture. The data also indicate very similar column performance between lots.
|POROS® Resin||HS50||HQ50||MabCapture® A Resin|
|Column dimension (cmD x cmL)||1.2 x 10||1.2 x 20||1.2 x 10||1.2 x 20||1.2 x 10||1.2 x 15|
|Date of manufacture||6/2/2011||2/16/2012||6/2/2011||3/8/2012||12/4/2011||9/17/2010|
|Number of columns in lot||7||10||7||10||6||12|
|Efficiency Specification||≥ 4,000 plates/meter|
|Pressure Specification||≤87 PSI|
Process validation activities can span long periods of time, making it important that critical raw materials supporting validation are consistent. GoPure™ columns are manufactured in a facility that is ISO 9001/ISO 13485-certified. Column materials of construction are defined in Table 2. Standardized, validated packing protocols for both POROS® and other resins enable consistency of product and reliable delivery times.
|GoPure™ Column Part Description||Material||Product Contact Component|
|O-ring||Ethylene propylene diene monomer (EPDM)||Yes|
|Frit, 5 µm||Titanium||Yes|
|Swage ring||316 stainless steel||No|
Columns are manufactured to defined specifications, as noted in Table 3. Each column is supplied with a Column Test Certificate that details performance against specifications and provides documentation of column suitability for use in scaled-down validation studies.
|Plates per Meter
|Pressure at Defined Flow
|POROS® resin||0.80–1.60||≥ 4,000 plates/meter||≤ 87 / 6|
|Other resin||0.80–1.60||≥ Resin manufacturer’s claims||Resin dependent|
* For POROS® resin, 1,000 cm/hr
Spend your time on value-adding process validation activities and order GoPure™ 1.2 cmD columns for your next process development campaign or process validation study.
For Research Use Only. Not for use in diagnostic procedures.