Biopharmaceutical Applications for Buffer or Reagent Solutions

Electrophoresis is a technique to separate macromolecules based on their size and charge. Predominantly used by biochemists and molecular biologists, a charge is applied and the various species migrate at differing rates. Over time they seperate. The charge needed for this separation is transferred by the ions present in buffers and as such buffers are integral to this process. The buffer also maintains pH by providing a weak base or acid reservoir.

Scientists typically use buffer solutions like citric acid, acetic acid and glycine.

In the field of biopharmaceuticals, to identify, purify and quantify the components of solutions is essential. Quality buffers maintain the pH of the mobile phase and bad buffers can damage or temporarily sideline expensive columns holding up your whole workflow.

Phosphate and acetate are commonly used for HPLC at wavelengths below 220nm. LabMinds’ Revo automated buffer solution preparation machine is used by biopharmaceutical companies to automate the preparation of mobile phase buffers in their analytical techniques.

Drug pH stability profiling is important during different stages of preformulation and analytical studies.

For this, pharmaceutical products are prepared in different buffer solutions by analytical scientists. Then scientists analyze the number of drugs that remain unchanged over a wide range of pH levels. Having precise control over your buffers in these experiments is key to generating informative stability data.

Prior to dosing, many formulations require tonicity adjustments to ensure minimal osmotic pressure differences between the patient’s tissue and the solution being introduced.  Often isotonic buffered diluting agents are used, like 0.9% NaCl, which is approximate to the osmotic pressure of body fluids ensuring minimal local fine tissue damage.

Many biopharmaceutical companies are using buffers in parenteral preparations (i.e., injectables) because it is vital to maintain the pH because a change in pH can impact the formulation.

To produce monoclonal antibodies, hundreds of liters of buffers and media are required per process or per batch. Buffers play an important role in the optimization and stability of process yield. By using automated buffer solution organizations will be able to have following benefits:

• Cell culture media usually contains sodium bicarbonate as buffering agent and pH is tightly controlled by using agent in media. Small pH deviations of 0.1 units from standard pH value can significantly impact culture growth and metabolism. Buffers are required to maintain proper medium development for yield production. They maintain chemical parameters like pH.
• In a very important step called the wash step.  Antibody solutions are cleansed with alkaline buffers (pH >  10). This lowers the number of free thiols, and thereby helps protect antibodies from irreversible aggregations.
• The use of buffers increases the production scale by reducing the number of purification steps and time for developing. Biopharmaceutical companies are looking for best buffer solutions for the preparations of monoclonal antibodies. LabMinds has designed the Automated Buffer preparation machine that makes aqueous based buffers from 500ml to 2L. This automated machine is needed to have good quality buffers.