ElbisAnalytical and preparative (GoPure) chromatographic columns packed with POROS sorbents
GoPure prepacked columns: custom packed columns facilitate 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 pre-packed chromatography columns, available packed with POROS and non-POROS resins, provide a convenient and cost-effective alternative to traditional 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