Chromatography Process Development and Optimization Services
Employing a range of state-of-the-art technologies validated and proven over several years in our Service Centers, we provide unique experience and assistance to enable protein purification optimization and help drive biological products into the clinic more efficiently. We have developed substantial expertise utilizing high throughput methods with 96-well Filter plates (AcroPrep™ Advance), Design of Experiments (DoE) and various analytical technologies to efficiently screen chromatography sorbent selectivities.
Protein Purification and Process Optimization
For target protein capture, selectivity conditions are screened with various sorbents dispensed in AcroPrep™ Advance 96-well Filter plates. Several binding and wash conditions can be tested in parallel (for example, pH, load, conductivity) and their impact on product critical quality attributes evaluated. After fractions analysis and selection of the best operating parameters, conditions are then directly transferred to traditional chromatography columns, significantly reducing chromatographic purification time and cost. Pall can also provide further assistance for scale-up to pilot scale or manufacturing.
The main advantages of this miniaturized approach are:
Quick selection of the best chromatography sorbents for target protein capture
Limited sample consumption
Options for impurity removal (polishing step)
Direct transfer to scalable chromatography columns
Protein Purification and Optimization Service Includes:
Determination of a direct capture step for the target protein from a crude sample
Development of polishing steps from the eluate of the previous step
Transfer to column chromatography
Re-optimization of an existing process
Prior to starting full testing, a detailed proposal is submitted for approval. Once feasibility has been checked by a simple lab trial, the full experimental plan is implemented. After completion of the testing, a comprehensive report is provided.
Ordering Information and Charges Each project is assessed individually. Wherever possible, we provide a fixed price in advance. Where this is not possible, we will offer an estimate to assist you in budgeting and cost control. The final invoice gives details on items such as labor and materials.