Evaluation of buffer stability for the production of small molecules

There are many types of buffering agent that can be used in the process line of biopharmaceutical industry. The most common buffering agent used in the biopharmaceutical industry mainly in the production of human recombinant insulin are ammonium acetate buffer, glycine buffer, potassium dihydrogen phosphate buffer, sodium acetate buffer, and tris(hydromethyl)aminomethane buffer solutions. These buffering agents are responsible to resist the pH changes throughout the production processes according to their compatibility towards the processes. The purposes of this research are to evaluate the stability of buffer solutions for a small molecules production mainly in the production of insulin and to propose the planning and management of the buffers uses and its storage. The research included the preparation of the buffer solutions, filtration of the buffer solutions, and the analysis of the buffer stabilities were based on the appearance changes, pH changes, and determination of the buffering capacities for each of the buffer solution. All the buffer solutions were stored at vary condition which are refrigerated and room temperature conditions. The buffering capacity for the ammonium acetate buffer is high in the room temperature condition. The glycine buffer rich in the buffering capacity when stored at the refrigerated condition. For the potassium dihydrogen phosphate, the buffering capacity is better in the room temperature. The buffering capacities for tris(hydromethyl)aminomethane and the sodium acetate buffer shows good buffering capacity at the room temperature respectively.