Buffers & pH Adjusters
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
Related Resources
- 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.
- 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.
- Tech Brief: Holistic Buffer Preparation
Buffer preparation is a critical but often undervalued operation in biologics production, with significant buffer volume consumption and potential process bottlenecks. This document will explore the optimization of in-house buffer preparation and considerations for outsourcing, recognizing that a combination of options may be the best solution based on process requirements.
- 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.
- 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.
- Formulation Product Finder
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.
Related Webinar
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