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Bioprocessing is an essential part of many food, chemical and pharmaceutical industries. Bioprocess operations make use of microbial, animal and plant cells. Bringing modern biotechnology to industrial fruition requires engineering skills and know-how.
Bioprocessing is an essential part of many food, chemical and pharmaceutical industries. Bioprocess operations make use of microbial, animal and plant cells. Bringing modern biotechnology to industrial fruition requires engineering skills and know-how.
Bioprocessing is an essential part of many food, chemical and pharmaceutical industries. Bioprocess operations make use of microbial, animal and plant cells. Bringing modern biotechnology to industrial fruition requires engineering skills and know-how.
Recent advances in biotechnology and public concern
about environmental pollution and the sustainability of natural resources have rapidly transformed the nations many manufacturing industries, from chemical to pharmaceutical, to become more environmentally benign and bio-based. For example, almost all major pharmaceutical companies now dedicate more than 50% of their new drug development to biotech R&D. Likewise, large chemical companies, such as DuPont and Dow Chemicals, are aggressively developing new bio-based products to replace petrochemical ones.
HISTORY AND APPLICATIONS of BIOTECH
Biotechnology has been
described as the last great technological innovation of the twentieth century and has touched upon almost every aspect of human life, from healthcare to agriculture to the production of industrial products (Figure 1).
Historical milestones in the
development of biotechnology
Some Major of Industrial Fermentation
Products
Steps in Bioprocess Development:
Bioprocessing is an essential part of many
food, chemical and pharmaceutical industries. Bioprocess operations make use of microbial, animal and plant cells and components of cells such as enzymes to manufacture newproducts and destroy harmful wastes. bioprocesses have been developed for an enormous range of commercial products, from relatively cheap materials such as industrial alcohol and organic solvents, to expensive specialty chemicals such as antibiotics, therapeutic proteins and vaccines.
Our ability to harness the capabilities of cells
and enzymes has been closely related to advancements in microbiology, biochemistry and cell physiology Tools of modern biotechnology such as RecDNA, gene probes, cell fusion and tissue culture offer new opportunities to develop novel products or improve bioprocessing methods. Although new products and processes can be conceived and partially developed in the laboratory, bringing modern biotechnology to industrial fruition requires engineering skills and know-how.
The interdisciplinary nature of bioprocessing is
evident
Look at the stages of bioprocess development required
for a complete industrial process.(see Fig. below) These stages involve different types of scientific expertise. -(Steps 1-11) are concerned with genetic manipulation of the host organism (molecular biology and biochemistry). Tools : Petri dishes, micropipettes, tubes, PCR machine, microcentrifuges, nano-or microgram quantities of restriction enzymes, and electrophoresis gels for DNA and protein fractionation.;
Figure1.Steps in development of a complete bioprocess for commercial new recProduct
(Step 12) : microbiology and kinetic analysis;
After cloning, the growth and production characteristics of the cells must be measured
Medium composition,pH, temperature and other
environmental conditions allowing optimal growth and productivity are determined. Calculated parameters such as cell growth rate, specific productivity and product yield are used to describe performance of the organismOptimum Condition of Culture
(Step13):Scale-up of the process starts. The first stage
may be a 1- or 2-Litre bench-top bioreactor equipped with instruments for measuring and adjusting temperature, pH, DO concentration, stirrer speed and other process variables. Information collected: O2 requirements of the cells, their shear sensitivity, foaming characteristics and other parameters. Limitations imposed by the reactor on activity of the organism must be identified. For example, if the bioreactor cannot provide O2 to an aerobic culturestarving or cell damage. The situation is assessed using measured and calculated parameters such as mass-transfer coefficients, mixing time, gas hold-up, rate of oxygen uptake,etc. It must also be decided whether the culture is best operated as a batch, semi-batch or continuous process;
(Step 14): the system is scaled up again to a
pilot-scale bioreactor.
A vessel of capacity 100-1000 litres is built according to
specifications determined from the bench-scale prototype. The aim of pilot-scale studies is to examine the response of cells to scale-up. Even though the geometry of the reactor, method of aeration and mixing, impeller design and other features may be similar in small and large fermenters, the effect on activity of cells can be great. Loss of productivity following scale-up may or may not be recovered; economic projections often need to be re-assessed as a result of pilot-scale findings.
(Step 15). industrial-scale
If the scale-up step is completed successfully,
design of the industrial-scale operation commences. Particular attention is required to ensure the fermentation can be carried out aseptically. When recombinant cells or pathogenic organisms are involved, design of the process must also reflect containment and safety requirements.
(Step 16), Downstream processing
An important part of the total process is product
recovery, also known as downstream processing. Product recovery is often difficult and expensive; for some recombinant-DNA-derived products, purification accounts for 80-90% of the total processing cost. Commercial procedures include filtration, centrifugation and flotation for separation of cells from the liquid, mechanical disruption of the cells if the product is intracellular, solvent extraction, chromatography, membrane filtration, adsorption, crystallisation and drying. Usually First developed and tested using small-scale apparatus Disposal of effluent after removal of the desired product must also be considered.
(Step 17).Packaging &marketing
After the product has been isolated in sufficient
purity it is packaged and marketed. For new pharmaceuticals such as recombinant human growth hormone or insulin, preclinical and clinical trials are required to test the efficacy of the product. Only after these trials are carried out and the safety of the product established, it can be released for general health-care application.
Bioprocess engineers (or Pharmacyst) with a
detailed knowledge of the production process are often involved in documenting manufacturing procedures for submission to regulatory authorities (FDA or BPOM in Indonesia).
As shown in this example, a broad range of
disciplines is involved in bioprocessing. Scientists working in this area are constantly confronted with biological, chemical, physical, engineering and sometimes medical questions. It is important for Pharmacyst to keep existence both in up stream and down stream process of bioprocessing.
The biological characteristics of cells and enzymes often
impose constraints on bioprocessing; therefore knowledge of them is an important prerequisite for rational bioprocess (engineering) design. For instance : - thermostability the operating temperature of reactor? - susceptibility of an organism to substrate determine whether substrate is fed all at once or intermittently? It is equally true, however,that biologists working in biotechnology must consider the engineering aspects of bioprocessing; selection or manipulation of organisms should be carried out to achieve the best results in production-scale operations.
Another area requiring cooperation and understanding
between engineers and laboratory scientists is medium formation. For example, addition of serum may be beneficial to growth of animal cells, but can significantly reduce product yields during recovery operations All areas of bioprocess development; the cell or enzyme used, the culture conditions provided, the fermentation equipment and product-recovery operations--are interdependent. Because improvement in one area can be disadvantageous to another, ideally, bioprocess development should proceed using an integrated approach.
As our exploitation of biology continues,
there is an increasing demand for scientists/pharmacyst trained in bioprocess technology who can translate newdiscoveries into industrial-scale production. As a biotechnologist, you could be expected to work at the interface of biology/pharmacy and engineering science.