Biological products, development

May, J. C., Wheeler, R. M., Etz, N., Del Grosso, A. Measurement of final container residual moisture in freeze-dried biological products. Developments in Biological Standardization Vol. 74, p. 153-164. Acting Editors Joan C. May, F. Brown, S. Karger AG, CH 4009 Basel (Switzerland), 1992... 

The modem advances of biotechnology create numerous ethical issues. Care should be taken in relating directly the therapy type and the ethical issue. Moreover, ethical standards vary among highly respected experts . Indeed, it can be said that, to some extent, everyone is an ethicist, and those involved in biological product development certainly should be. 

Assisting their Medical, Biological, Product Development, and Biopharmaceutics departments in the planning of projects and data analysis. 

La Salle, B. (1977). Problems of contamination, exposure and pollution in freeze-drying biological products. Int. Symp. on Freeze-Drying of Biological Products. Develop, biol. standard., 36, 201-205. S. Karger, Basel. 

Synthetic Heme. Synthetic compounds that biad or chelate O2 have been produced. These compounds are commercially attractive because manufacture and Hcensure might be developed as a dmg, rather than as a biological product. It has been shown that synthetic hemes can be used to transfuse animals (53). Although synthetic O2 carriers would avoid the limited hemoglobin supply problem, the synthetic procedures are very tedious, and the possibihty of scale up seems remote. 

TOF-SIMS has important potentials in many areas of life science, in fundamental and applied research as well as in product development and control. This holds for the characterization of biological cells and tissues, of sensor and microplate arrays, of drug delivery systems, of implants, etc. In all these areas, relevant surfaces feature a very complex composition and structure, requiring the parallel detect ion of many different molecular species as well as metal and other elements, with high sensitivity and spatial resolution requirements, which are exactly met by TOF-SIMS. 

Program Capabilities The NIAID program has the capability of performing all the necessary development tasks to support the submission of an INDA for small molecules and biological products, including, but not limited to, the services below ... 

---