Biopharmaceutical applications

As described in the following chapter, there are many biopharmaceutical applications of protein assays. Assigning the protein concentration for the drug substance, drug product, or in-process sample is often the first task for subsequent analytical procedures because assays for purity, potency, or identity require that the protein concentration be known. Hence it is typical for several different methods to be employed under the umbrella of protein concentration measurement, depending on the requirements of speed, selectivity, or throughput. The protein concentration is valuable as a stand-alone measurement for QC and stability of a protein. However, protein concentration methods provide no valuable... 

Scale-Up and Optimization in Preparative Chromatography Principles and Biopharmaceutical Applications, edited by Anurag S. Rathore and Ajoy Velayudhan... 

Advances by reputable manufacturers have removed some of the perceived disadvantages of rubber, in particular the refinement of rubber formulations to reduce the level of extractives. The development of a fluoropolymer-based laminate under the FluroTec product range to provide real barrier properties has simplified the complex process of rubber closure selection and offered a level of security not available with a conventional closure. The use of such laminated closures is predicted to increase in the future, in particular these are likely to be specified as the closure system for biopharmaceutical applications. 

H. R. Costantino and M. J. Pikal, Lyophilization of Biopharmaceuticals, Chapter 13 Spray Freeze Drying of Biopharmaceuticals Applications and Stability Considerations. American Association of Pharmaceuticals Scientists Springer, Arlington, (2004). 

We have developed a proprietary acoustic wave device which permits the detection of a specific analyte in a flowing system. By coupling specific chemistry (Protein A) to the surface of the device, the mass loading of the device by the target analyte (Human IgG) was detected as a shift in phase which was measured in real time. Using conditions which mimic a bioprocess separation for IgG, we were able to separate and detect Human IgG at 1 mg/ml and 100 ug/ml in the absence and presence of 10% Fetal Bovine Serum. Such a detector has the potential to increase productivity in process chromatography in biopharmaceutical applications. 

Because NPs can be synthesized chemically, free of animal-derived components, they are ideal for use when absence of animal-derived components is a priority, for example, in biopharmaceutical applications. Absence of animal-derived components may also facilitate regulatory compliance. 

To date, the polymer material most widely used for biopharmaceutical applications is polystyrene (PS). Injection-molded PS labware is produced cost effectively and is available in a variety of sizes, shapes and biofunctionality on predefined geometrical... 

HPLC of Biological Macromolecules Second Edition, Revised and Expanded, edited by Karen M. Gooding and Fred E. Regnier Scale-Up and Optimization in Preparative Chromatography Principles and Biopharmaceutical Applications, edited by Anurag S. Rathore and AJoy Velayudhan... 

The hemocompatibility of hydrophilic materials is relevant for standard blood-contacting medical devices, but there are additional applications for which the protein-resistant properties are useful. Hydrophilic materials play a large role in the membrane industry, where improved wet-out improves solution flow through the membrane additionally, hydrophilic membranes show less protein fouling (55). In the realm of engineering thermoplastics, low protein binding materials are useful in lab equipment and in biopharmaceutical applications... 

Krishna, R. and Yu, L. Biopharmaceutics Applications in Drug Development. Springer, New York, 2007. 

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