Compositions comprising high concentration of biologically active molecules and processes for preparing the same

A large scale process for producing high purity samples of at least one biologically active molecule of interest from bacterial cells, comprising the steps of:

• contacting the bacterial cells in a dispersion of cells with lysis solution to form a lysate solution;
• neutralizing the lysate solution by mixing a neutralization solution into the lysate solution with a bubble column mixer to form a neutralized mixture;
• filtering the neutralized mixture through a primary filter and a secondary filter to form a filtered solution;
• passing the filtered solution through an ion-exchange column to form a ion-exchange solution;
• passing the ion-exchange solution through a hydrophobic interaction column or a hydrophobic interaction membrane to form a hydrophobic interaction solution;
• and
• ultrafiltration of the hydrophobic interaction solution to form a high purity sample of at least one biologically active molecules of interest;
• wherein each transition from one step to a subsequent step in the large scale process from the contacting step to the passing the filtered solution step occur substantially continuously.