Buffer Solutions

for you

Fundamental

The Importance of Buffer Solutions in Biopharmaceutical Manufacturing

Buffer solutions are fundamental throughout biopharmaceutical production, from initial cell culture to final formulation. They maintain pH stability, which is crucial for the activity, stability, and bioavailability of APIs and sensitive biomolecules.

As biopharmaceuticals become more targeted, selecting the right buffer—and a reliable manufacturing partner—is key to success.

Buffer Solutions to go

Applications and Functions in the Production Process

Cell Culture & Upstream Processing: Buffers create optimal environments for cell growth and consistent biomolecule production by stabilizing pH over time.
Downstream Processing & Purification: Buffers are vital during protein separation, purification, and filtration, supporting processes like chromatography, ultrafiltration, and diafiltration.

Final Formulation: In the last stage, buffers stabilize the active ingredient, ensuring product efficacy and shelf life, especially for complex drugs like monoclonal antibodies."

Types of Buffer Solutions and Customization

Biopharmaceutical manufacturers use a variety of buffers—phosphate, acetate, citrate, and Tris—each with specific pH ranges and buffering capacities. The right buffer is chosen based on the active ingredient and process requirements.

CG Pharma & Biotech also develops customized buffer solutions tailored to exact customer specifications for pH, ionic strength, and composition.

CG Pharma & Biotech's
Buffer Portfolio

Phosphate, acetate, citrate, and Tris buffers
Custom-made buffers for specific process needs
Single-use buffer bags in various sizes and configurations

All products are manufactured under strict quality standards, with full traceability and extensive quality testing to ensure optimal performance in biopharmaceutical manufacturing.

Quality Assurance and Compliance

All buffer solutions are produced in EU-GMP certified facilities in Hannover, Germany, under a manufacturing license according to the German Medicines Act.

Each batch is fully traceable, documented, and reviewed by a Qualified Person before release, ensuring compliance with regulatory and industry standards.

Quality