Buffers & pH Adjusters

Buffer and pH Adjuster

Buffer quality is vital for the success of biopharmaceutical processes, as well as small molecule formulation, because buffers are indispensable in nearly every production step. Our broad portfolio of buffer materials manufactured under appropriate controls is tailored to your needs. Ranging from non-GMP production to manufacturing according to GMP guidelines including excipients specifically for drug formulation and including high-risk applications. Whether your product is a small or large molecule drug, we offer high-quality buffers and pH adjusters backed by extensive regulatory support.  

  • All products manufactured under appropriate controls
  • Multi-compendial, where applicable
  • Low bioburden and endotoxin levels
  • Low UV-absorbance of aqueous solutions
  • Comprehensive documentation and regulatory support

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We cover all commonly used buffering systems such as phosphates, acetates, and citrates, as well as customized buffers and organic buffers that include TRIS, HEPES, MES, BIS-TRIS, PBS, imidazole, and many more. If you need a global supply partner capable of fast, flexible turnaround, our manufacturing locations around the world can provide high-quality biological buffers manufactured according to GMP guidelines, in quantities from a gram to metric ton scale.

Ensuring Reproducibility while Minimizing Risk

All buffering products use qualified, high-purity raw materials of defined specifications to ensure reproducible processing, manufactured with processes that are designed to minimize microbiological contamination and concentrations. Consequently, drug manufacturers worldwide rely on our products for:

  • Formulating any kind of liquid medicinal product for oral, topical, ophthalmic, otic, inhalative, or nasal administration
  • Optimizing pH and other upstream process parameters to obtain needed product characteristics
  • Maintaining defined purification conditions downstream to stabilize valuable proteins and protect against contamination

Speeding you Through the Regulatory Maze

As part of our Emprove® Chemicals portfolio, buffers and pH adjusters are supported with comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve processes.

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