Biological buffer applications in Pharmaceuticals

 

Biological buffers are organic substances that maintain a solution's pH close to constant. They are used throughout the manufacturing process of biologics, mainly in upstream (USP) and downstream (DSP) processes.

Buffers are utilized in USP because of their ability to help keep culture pH within a certain range and optimize conditions for cell growth.

 

Typical USP biological buffers include: 

  • TRIS: Preparation of other buffers such as TAE and TEB buffers. Higher compatibility than classical citrate buffers with microbial host systems.

  • HEPES: cell culture with a pH requirement of 7.2 – 7.4

  • MES: cell culture with a pH requirement of 5.2 – 7.1

  • MOPS: cell culture with pH requirement near neutral

During DSP, buffers allow to preserve specified purifying conditions, regulate the ionization state of a protein when required for column chromatography, and stabilize the protein.

 

Typical DSP biological buffers include: 

  • HEPES-buffered saline (HBS)

  • TRIS and tricine: electrophoresis and purification

  • MES: chromatography (gel-filtration, phosphor-cellulose column, hydrophobic interactions

  • Electrophoresis)

  • MOPS: filtration stages, separation technique with polyacrylamide gel electrophoresis

  • CAPS : cation exchange chromatography and capillary electrophoresis

  • CHAPS : cell lysis when biological proteins is expressed intracellularly, used as non-denaturing detergent during protein purification.

Biological buffers commonly used in biologic processes can have different grade compliant with American Chemical Society, Pharmacopeial or USP-NF specifications.

 

For choosing the right buffer and supplier, manufacturers must perform a thorough quality control assessment to determine necessary quality specifications. After sample trials and if buffer is suitable for a given biologic process, cost and ease of preparation become essential considerations for scaling up.

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