Biological Material Production

The design of a production facility provides important information regarding whether the facility is intended to produce pharmaceutical grade products or biological weapon grade materials. Relevant design elements include containment, purification equipment, sterilization equipment, and ventilation and filtration systems. 

The prirnar) difference between the production requirements for biological weapons and non-military commercial purposes lies in containment and contamination. During 

Seed stocks of the AG group of biological agents are readily available in the natural environment and from culture collections in the industrialized and in some developing nations. The recent outbreaks of Ebola in Africa and Hanta virus infections in Asia and North and South America are evidence of this. In addition, these organisms may be obtained from national collections (e.g., American Type Culture Collection fATCCJ and European collections). 

Most industrialized nations manufacture equipment and materials necessary for the production, containment, purification, and quality control of these materials. Canada, France, Germany, Israel, Japan, the Netherlands, Russia, Sweden, Switzerland, the Ukraine, the UK, and the United States are the most advanced countries in the techniques of manufacturing large quantities of biological agents and protective vaccines and materials required for prophylaxis and therapy. See Appendix D, Table 5 for a list of Biological Material Production Technology Parameters 

Biological weapons production can be divided into three distinct phases biological 

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Pharmaceutical manufacturing entails the combination of a number of unit processes. The major processes have been described in this article. Brief outlines of the applications of these processes to parenteral, solid dosage form, and biological materials production are given. 

TABLE 5. Biological Material Production Technology Parameters... 

It is evident that the area of water-soluble polymer covets a multitude of appHcations and encompasses a broad spectmm of compositions. Proteins (qv) and other biological materials ate coveted elsewhere in the Eniyclopedia. One of the products of this type, poly(aspartic acid), may be developed into interesting biodegradable commercial appHcations (70,71). 

The purpose of this subsection is to introduce the reader to the tech-niqiies and methods used to recover materials, conversion products, and energy from solid wastes. Topics to be considered include (I) processing techniques for solid waste, (2) processing techniques for hazardous wastes, (3) materials-recoveiy systems, (4) recovery of biological conversion products, (5) therm processes, and (6) waste-to-energy systems. 

In passive attack, biological material acts as a chemically inert substance. Wastage is an indirect consequence of the biological mass or biological by-products. Biomass acts as any deposit accumulation would,... 

The destiny of most biological material produced in lakes is the permanent sediment. The question is how often its components can be re-used in new biomass formation before it becomes eventually buried in the deep sediments. Interestingly, much of the flux of phosphorus is held in iron(lll) hydroxide matrices and its re-use depends upon reduction of the metal to the iron(ll) form. The released phosphate is indeed biologically available to the organisms which make contact with it, so the significance attributed to solution events is understandable. It is not clear, however, just how well this phosphorus is used, for it generally remains isolated from the production sites in surface waters. Moreover, subsequent oxidation of the iron causes re-precipitation of the iron(lll) hydroxide floes, simultaneously scavenging much of the free phosphate. Curiously, deep lakes show almost no tendency to recycle phosphorus, whereas shallow... 

Polarographic methods can be used to examine food and food products biological materials herbicides, insecticides and pesticides petroleum and petroleum products pharmaceuticals. The examination of blood and urine samples is frequently carried out to establish the presence of drugs and to obtain quantitative results. 

In more recent times chemically defined basal media have been elaborated, on which the growth of various lactic acid bacteria is luxuriant and acid production is near-optimal. The proportions of the nutrients in the basal media have been determined which induce maximum sensitivity of the organisms for the test substance and minimize the stimulatory or inhibitory action of other nutrilites introduced with the test sample. Assay conditions have been provided which permit the attainment of satisfactory precision and accuracy in the determination of amino acids. Experimental techniques have been provided which facilitate the microbiological determination of amino acids. On the whole, microbiological procedures now available for the determination of all the amino acids except hydroxy-proline are convenient, reasonably accurate, and applicable to the assay of purified proteins, food, blood, urine, plant products, and other types of biological materials. On the other hand, it is improbable that any microbiological procedure approaches perfection and it is to be expected that old methods will be improved and new ones proposed by the many investigators interested in this problem. 

Bioprocess plants are an essential part of food, fine chemical and pharmaceutical industries. Use of microorganisms to transform biological materials for production of fermented foods, cheese and chemicals has its antiquity. Bioprocesses have been developed for an enoimous range of commercial products, as listed in Table 1.1. Most of the products originate from relatively cheap raw materials. Production of industrial alcohols and organic solvents is mostly originated from cheap feed stocks. The more expensive and special bioprocesses are in the production of antibiotics, monoclonal antibodies and vaccines. Industrial enzymes and living cells such as baker s yeast and brewer s yeast are also commercial products obtained from bioprocess plants. 

The field of modified electrodes spans a wide area of novel and promising research. The work dted in this article covers fundamental experimental aspects of electrochemistry such as the rate of electron transfer reactions and charge propagation within threedimensional arrays of redox centers and the distances over which electrons can be transferred in outer sphere redox reactions. Questions of polymer chemistry such as the study of permeability of membranes and the diffusion of ions and neutrals in solvent swollen polymers are accessible by new experimental techniques. There is hope of new solutions of macroscopic as well as microscopic electrochemical phenomena the selective and kinetically facile production of substances at square meters of modified electrodes and the detection of trace levels of substances in wastes or in biological material. Technical applications of electronic devices based on molecular chemistry, even those that mimic biological systems of impulse transmission appear feasible and the construction of organic polymer batteries and color displays is close to industrial use. 

A wide variety of reference materials is now available, covering several different kinds of natural matrix such as food (e.g. milk powder), human tissues (e.g. liver), marine biological materials (e.g. tuna fish) and soils and sediments. The radionuclides of interest cover naturally occurring ones (e.g. Ra), fission products... 

Health, Environmental, Quarantine and Other Regulations Many countries have strict regulations designed to protect the ecosystem and agrochemical business. For example any matrix material derived from pork, beef, sheep or horse tissue has to be accompanied with a Veterinary Certificate confirming that the matrix material is free of certain specified diseases before it can be imported into the EU. The Australian import restrictions are even tougher and require the importer to obtain prior permission to import plant and animal materials and products derived from biological materials. To get an import license it is necessary to complete an application, which includes information from the producer about the actual production process used to prepare the matrix ... 

The identification and structural characterization of biological materials, obtained for example from plants, was traditionally carried out via the classical sequence involving extraction, separation, isolation and characterization, a sequence which requires large amounts of substance and a great deal of time. Industrial problems, for example the search for small amounts of contaminants in industrial products or in waste water, also require intensive analytical studies. 

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