PH Adjustment and Buffers

Key benefits:

• High product consistency: Our comprehensive global Quality Management System ensures a robust process control designed to yield high-purity raw materials for reproducible processing.
• Comprehensive buffer offering: Broadest buffer portfolio for the pharmaceutical industry with a global manufacturing network at different quality levels to fit your needs from early upstream to high risk applications.
• Risk mitigation: Our Emprove^® Program provides comprehensive documentation, process control, and supply chain transparency that goes beyond today’s regulatory standards – helping you to navigate regulatory challenges, manage risk and improve your manufacturing processes.
• Process efficiency:
  • Whatever your requirements, we are your partner, supporting you with standard and tailored solutions such as powder blending, quality support, dedicated testing protocols or specific packaging options such as direct dispense and DRYPOUR™.
  • A portfolio of granulated materials with reduced caking behavior and right size weighed products in bags, specifically developed to increase process efficiency, support operator safety, and speed up manufacturing processes.

Section Overview:

• pH Adjusters to change the pH value
• Buffer ingredients to stabilize pH value
• The Role of pH Adjusters and Buffers in Bioprocessing

pH adjusters to change the pH value

The ‘potential of hydrogen’ (pH) is a logarithmic scale to define the acidity or basicity of an aqueous solution. pH adjusters are used to control and optimize the pH in small and large molecule manufacturing. We offer commonly used pH adjustment chemicals including citric acid, hydrochloric acid, acetic acid and sodium hydroxide.

Buffer ingredients to stabilize pH value

Buffers resist pH changes upon addition of an acid or base over a given range and are therefore used in maintaining required pH conditions throughout the process. We cover all commonly used buffering systems such as phosphate buffers, acetate buffers, citrate, carbonate buffers, TRIS, HEPES, MES, BIS-TRIS, imidazole, as well as customized buffer solutions. Buffer additives such as stabilizers, antioxidants and salts are also required to maintain the stability of the product.

The role of pH adjusters and buffers in bioprocessing

Buffers and pH adjusters play a critical role in controlling the pH to preserve the stability and functionality of proteins or other large molecules in all phases of bioprocessing including upstream, downstream, and final formulations.

Upstream

In the upstream process, buffers help to maintain a consistent pH environment, optimizing growth conditions for the production of biological compounds.

Downstream

In downstream processing, product purification techniques involve a variety of buffers and pH adjusters used in conjunction with other compounds such as salts, detergents, amino acids, and cleaning reagents. Buffers are a critical component in downstream processes as they maintain purification conditions while stabilizing the large molecule of interest.

Formulation

In the final formulation, buffers are instrumental in maintaining pH conditions and ensuring the stability and therapeutic functionality of the final drug throughout storage.

Regardless of the process step, buffers and pH adjusters must exhibit high purity, solubility, and minimal interaction with other compounds. For this reason, our buffers and pH adjusters are high-quality raw materials that meet stringent regulatory standards. Whenever you need assistance, our technical experts are available to support your process and formulation development activities, ensuring the stability of your final formulation.