Purification Overview (GFP Purification part 1 of 6) скачать в хорошем качестве

Purification Overview (GFP Purification part 1 of 6)

There are two main operations used within purification: Chromatography and Filtration. Our GFP process is pretty typical for biopharmaceutical products. The clarified lysate is pre-filtered, goes through Anion Exchange Chromatography, and then collected and pooled. Next, Ammonium sulfate is added to make the solution high-salt followed by Hydrophobic Interaction Chromatography. The GFP is then collected and pooled again. The solution then goes through a TFF ultrafiltration step – which includes concentration of the GFP followed by Diafiltration to exchange buffer solutions and remove salt. And the process finishes up with Final Filtration into bulk bottles or bags The Purification process is managed through the use of a Batch Process Record. These documents lead the operator step-by-step...and require a sign-off and verification by a second operator. The Purification area must be cleaned, disinfected and organized. Any unneeded equipment or materials are removed. All required materials and documentation must be gathered and prepared before the process may begin.