Indus chapter 1-11

• Biotechnology


  Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use
• Examples of biotechnology


  • Use of microorganisms to make penicillin or yoghurt
  • Use of microorganisms to produce amino acids or enzymes
• Traditional biotechnology


  Does not directly involve nucleic acid or molecular manipulations
• Nucleic acid biotechnology


  Involves biological manipulations at the molecular level, such as genetic engineering
• Industrial microbiology


  The study of the large-scale and profit-motivated production of microorganisms or their products for direct use, or as inputs in the manufacture of other goods
• Industrial microbiology


  Is a branch of biotechnology and includes both traditional and nucleic acid aspects
• Industrial microbiology


  • Immediate motivation is profit and generation of wealth
  • Microorganisms or their products are very valuable and the raison d'etre for the existence of the industrial microbiology establishment
  • Scale of operations is large, with microorganisms cultivated in fermentors as large as 50,000 liters or larger
• Medical microbiology


  • Immediate concern is to offer expert opinion to the doctor to restore the patient to good health
  • Microorganisms per se have little or no direct economic value, outside the contribution they make to ensuring the return to good health of the patient
  • Scale of operations is limited to a loopful or a few milliliters
• Industrial microbiology is a multi-disciplinary or team-work endeavour, involving microbiologists, chemical or production engineers, biochemists, economists, lawyers, marketing experts, and other high-level functionaries
• Key functions of the microbiologist in an industrial microbiology organization

  • Selection of the organism to be used
  • Choice of the growth medium
  • Determination of the environmental conditions for optimum productivity
  • Monitoring the process for contaminants and participating in quality control
  • Proper custody of the organisms in a culture collection
  • Improvement of the microorganisms' performance by genetic manipulation or medium reconstitution
• Less efficient microbiological methods are discarded in industrial microbiology as better ones are discovered, and a microbiological method may be entirely replaced by a cheaper chemical method
• Many procedures employed in industrial microbiology are kept secret or patented by companies to maintain a competitive advantage
• Patents


  Intended to induce an inventor to disclose their invention, and ensure the inventor is rewarded for their innovation
• Requirements for patentability


  • Invention must be new, result from inventive activity, and be capable of industrial application
  • Invention must not be part of the existing body of knowledge (the 'state of the art')
  • Invention must not obviously follow from the state of the art
• Principles and discoveries of a scientific nature are not necessarily inventions for the purposes of patent laws
• Microorganisms per se are not patentable, except when they are used as part of a 'useful' process
• A live human-made micro-organism is patentable, as established by a 1980 US court ruling
• Microorganisms are patentable as part of a useful 'process', i.e. when they are included along with a chemical or an inert material with which jointly they fulfill a useful purpose
• The Appeals Court reversed the earlier judgment of the lower court and established the patentability of organisms imbued with new properties through genetic engineering
• Microorganisms by themselves are not patentable, being 'products of nature' and 'living things'
• Microorganisms are patentable as part of a useful 'process' i.e. when they are included along with a chemical or an inert material with which jointly they fulfill a useful purpose
• It is the organism-inert material complex which is patented, not the organism itself
• A US patent dealing with a bacterium which kills mosquito larva granted to Dr L J Goldberg in 1979


  • A bacterial larvicide active against mosquito-like larvae comprising: a. an effective larva-killing concentration of spores of the pure biological strain of Bacillus thuringiensis var. WHO/CCBC 1897 as an active agent; and b. a carrier
• It is the combination of the bacterial larvicide and the carrier which produced a unique patentable material, not the larvicide by itself
• When a new antibiotic is patented, the organism producing it forms part of the useful process by which the antibiotic is produced
• A new organism produced by genetic engineering constitutes a 'manufacture' or 'composition of matter'
• Things that are patentable

  • Creation of new plasmid vectors
  • Isolation of new DNA restriction enzymes
  • Isolation of new DNA-joining enzymes or ligases
  • Creation of new recombinant DNA
  • Creation of new genetically modified cells
  • Means of introducing recombinant DNA into a host cell
  • Creation of new transformed host cells containing recombinant DNA
  • A process for preparing new or known useful products with the aid of transformed cells
  • Novel cloning processes

  
• Patents resulting from the above were in general regarded as process, not substance, patents
• Biotechnological process


  A process of genetically altering or otherwise inducing a single- or multi-celled organism to: (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; Cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; A method of using a product produced by a process defined by (i) or (ii)

  
• The patenting of a microbiological process places on the patentee the obligation of depositing the culture in a recognized culture collection
• The rationale for the deposition of culture in a recognized culture collection is to provide permanence of the culture and ready availability to users of the patent
• The cultures must be pure and are usually deposited in lyophilized vials
• Where a microbiologist-inventor is an employee, the patent is usually assigned to the employer, unless some agreement is reached between them to the contrary
• In certain circumstances it may be prudent not to patent the invention at all, but to maintain the discovery as a trade secret
• The decision whether to patent or not must be considered seriously, consulting legal opinion as necessary
• The right to patent in respect of an invention is vested in the statutory inventor, that is to say that person who whether or not he is the true inventor, is the first to file the patent application
• Fermentation (in microbial physiology)


  The type of metabolism of a carbon source in which energy is generated by substrate level phosphorylation and in which organic molecules function as the final electron acceptor (or as acceptors of the reducing equivalents) generated during the break-down of carbon-containing compounds or catabolism
• Fermentation (in industrial microbiology)


  Any process in which micro-organisms are grown on a large scale, even if the final electron acceptor is not an organic compound (i.e. even if the growth is carried out under aerobic conditions)
• Fermented food


  A food, the processing of which micro-organisms play a major part, determining the nature of the food through producing the flavor components as well deciding the general character of the food, but microorganisms form only a small portion of the finished product by weight
• Examples of fermented foods

  • Cheese
  • Bread
  • Yoghurt