pH Adjustment and Buffers
Buffers and pH adjusters play a critical role in controlling pH in small molecule formulation and all phases of large molecule bioprocessing from media preparation to final fill and finish.
We provide an extensive portfolio of buffer and pH adjuster materials designed to accommodate different stages of drug manufacturing. Our range of solutions caters to a variety of needs, offering Emprove® Evolve materials for early-stage applications, manufactured under a quality management system based on ISO 9001:2015 with an enhanced quality program, as well as Emprove® Essential and Emprove® Expert products suitable for drug formulation including high-risk applications, manufactured according to IPEC PQG GMP guidelines. All products are manufactured under appropriate controls to meet your specific requirements and are backed by extensive regulatory support.
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.
Related Product Resources
- Tech Brief: Holistic Buffer Preparation
Buffer preparation is a core operation of all biologics production processes. Buffers are used throughout processing from media preparation to final filtration, and although reliable buffer preparation is critical, the operation is often considered low added value.
- Article: Reproducibility with Biological Buffers
Biological buffers are organic substances that maintain a constant pH over a given range by neutralizing the effects of hydrogen ions.
- Brochure: Your Partner for Liquid Dose Applications
We offer an extensive portfolio of raw materials for liquid dosage forms, manufactured in compliance with the IPEC-PQG GMP Guideline, to support your pharmaceutical development, scale-up, and production needs. Backed by expert regulatory knowledge and the Emprove® Program, our high-quality excipients aim to simplify material qualification, accelerate processes, and reduce the total cost of ownership for your final product.
- Tool: Pharmaceutical Application Guide
A search tool to help you overcome your process challenges.
- Product Guide: Raw Materials for Biopharmaceutical Manufacturing
The development of pharma and biopharma products requires materials as well as the expertise on how to use them. The SAFC portfolio of ready-to-use and customized material solutions were developed to meet the specific needs of pharma and biopharma production and backed by deep regulatory expertise.
- Buffer Reference Center
Choose and prepare a biological buffer based on your pH requirements as well as the pKa, a measure of acid strength that accounts for pH, concentration, and temperature.
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.
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