Industrial microbiology has emerged as an area of activity having marked realised and potential impact on virtual all domains of human welfare. The continuous development in the knowledge of science and technology gives us firm foundations for the scope of this dynamic science. It is all about of microbes and their products . As we know , microbes (Algae, Fungi , Bacteria , Virus, Actinomycetes, Mycoplasma etc) , are not visible to us from naked eye, they can be only seen with the help of microscope that’s why they are called microbes . Since they are associated with many diseases , they need to be studied for their specific associations with human cell mechanisms . This understanding paves the way for Pharmaceutical microbiology, where we study about how to control the diseases caused by microbes and how to use their metabolic products to combat diseases caused by them or by their relatives i.e microbes . However this is not so easy because , microbes are diverse, omnipresent , very opportunistic and can be easily mutated . Microbes are mainly associated with five different products as a part of their different phases of metabolosm. They are Enzymes, Organic acids, Alcohols , Transformation products and Recombinant products . The exploitation of microorganisms and their products has assumed an increasingly prominent role in the diagnosis, treatment and prevention of many human diseases.
In Pharmaceutical lab, quality contol and quality
assurance is an important unit. Here we study and work all about maintaining the quality of the
drugs. It mainly focuses on the chemical and microbiological aspects of drugs . Based on pharmacopeial guidelines (USP, BP, JP, EP ), regulated processes are maintained to ensure the quality
products with minimal risk. Hence it is important to have proper knowledge of
microbes for quality control/Quality assurance lab in pharmaceutical industry.
Based on my research and experiences , it is very
important to know about Scope of Pharmaceutical Microbiology in
the development of quality drugs . For this we should have depth knowledge
about :
General
microbiology: This explains about history of microbiology, morphological details ,
taxonomy, ecology, staining and preservation of microbial cultures,
microbiological assay (eg. Ames test, IMViC test)
Microbial
tools and technique: Here we learn about all digital devices and
their operations with the applications of biostatistics , bioinformatics and
computational biology.
Microbial
biochemistry: Microbial metabolism, another
important aspect , production of different products and their effect on immune system, development of
drug and their target sites to combat infectious diseases, to transform the produced microbial
product for pharmaceutical product. Evaluation and assesment of possible
synergistic antimicrobial combinations . Development of microbial models to
study the mammalian drug metabolism. Route of adminisration and resistence of
the patient .
Bioprocess
technology: To
understand how setup will work it is important to know about; mmobilization of
whole cells or their products . Basic fermentation operations for production of
wide range of products like, organic
acids , alcohols, antibiotics, vacccines, vitamins , amino acids, steroids,
probiotics and many other transformation and genetically modified products
Microbial
genetics and recombinant DNA technology: Here we develop all the control for targeted gene
expression and coding mechanisms , mutations, carcinogen, teratogens , strain improvement , development of
synthetic vaccines, to control pathogenicity .
Environmental
microbiology: This includes prevention of microbial
infection of air, water, soil, biosafety,
sanitation in manufacturing and production processes , proper sterilization of pharmaceutical plant and
disinfection to prevent contamination . It
includes GMP , GLP, HACCP , water test and
limit test , to measure the extent of microbial contaminations and their outcome
. It is important to understand the major factors affecting the availability of
APIs ( active pharmaceutical ingredients), preservation of drugs ,
preservatives used in formulations .
Therefore it heavily focuses on the quality control
operations to ensure supply of life – saving drugs and vaccines are free form contaminations of
microbes . It aims towards the active participation in microbial science
including the resistance and re-emerging theories regarding , policies , emerging trends, barriers
and opportunities to stimulate drug discovery and development. It also includes
formulation design and development , antimicrobial stewardship and post market surveillance ………
