Protein Solution

Protein solutions are used for parenteral therapeutics such as monoclonal antibodies and vaccine components, made through biological processing techniques.

Proteins can be extracted from biological sources or produced through recombinant DNA using genetically engineered organisms. Protein solutions contain buffers, salts, proteins and water. Viscosity varies with protein concentration. Higher concentrations are desirable to enable delivery by subcutaneous injection rather than IV. Even if the final product isn’t high in concentration, proteins can be at high concentrations during manufacturing, such as in ion-exchange column chromatography. The higher the concentration the greater the viscosity and tendency for protein clumping. These solutions are extremely sensitive to shear forces and must be protected from contamination.

Hygienic positive displacement pumps are well suited to handle the range of viscosities, minimize shear, and prevent contamination. Their large cavities gently transport the solution to prevent damage to sensitive proteins. To protect against contamination, Viking hygienic pumps meet critical hygiene requirements, including Regulatory Compliance (3-A Sanitary Standards, USP Class VI materials, ATEX and CE certifications); Sanitary Design (surface finish requirements for cleanability, CIP/SIP system integration, material compatibility); and Documentation Support (material certifications and traceability, performance validation data, installation and maintenance documentation).

Viking in the Process

Viking hygienic pumps are used to transfer the crude extract solution to purification, often centrifugation, precipitation or chromatography, and transfer final solution to storage or packaging.