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www.safcpharma.com
ProClin
®
Preservative
for Diagnostic Reagents
Packaging Information
 
SAFC Pharma
®
pipeline partners
Through Microbial Fermentation
Production of Pharmaceutical Compounds
Overview
The original denition of fermentation is ‘the anaerobic
conversion of sugar to carbon dioxide and alcohol
by yeast’, and most of us will have had rst-hand
experience of the fermentation process through its
most famous and popular use - the brewing of beer.This original denition has been expanded over timeto ‘the conversion of organic materials into relativelysimple substances by microorganisms- essentiallyefcient, exible bio factories.’ During their growth
and lifespan microorganisms build a wide range of different molecules types required for viability andmultiplication; adaptation to changing environment;stressful conditions and defence against hostile,
competitive microbial threats.
Microorganisms that are typically used within thepharmaceutical industry include: prokaryotes such
as Bacteria (e.g. Escherichia coli, Staphylococcusaureus) and Streptomycetes (e.g. Streptomyces spp,
 Actinomyces spp), eukaryotes such as Filamentous
Fungi (e.g., Nigrospora spp, Aspergillus spp,) and Yeast (e.g. Saccharomyces cereviciae, Pichia pastoris).
The molecules that are of primary interest to thepharmaceutical industry are small molecules suchas short peptides and low molecular weight organicmolecules, larger molecules including proteins and
nucleic acids (DNA, RNA) and macromolecules
such as lipids and carbohydrate polymers, plusvarious combinations of product types, for example
lipopolysaccharides, lipopeptides, peptidoglycan.
 Any of these product types could potentially serve as
a drug’s Active Pharmaceutical Ingredient (API).
Microbial Fermentation–an Introduction
Microbial fermentation is the basis for the productionof a wide range of pharmaceutical products, targeting
practically any medical indication. Examples range
from anti cancer cytotoxic drugs and vaccines,anti infectious disease antibiotics and vaccines, to
hormonal disorder therapy and many other indications.Natural biosynthesis of endogenous moleculesinvolves specic multi-step complex routes, some
of which can be manipulated for the biosynthesis of 
foreign molecules. Microorganisms may be geneticallymodied (recombinant technology) or metabolically
engineered by substantial alteration of their
endogenous routes.
The key elements of fermentation development arestrain selection and optimization, media and process
development, and nally, scale-up to maximizeproductivity. Downstream processing utilizes various
technologies for extracting, concentrating and purifying
the product from a dilute fermentation broth.Fermentation derived product diversity- the recoveryand selective purication of the specic desiredproduct out of the whole molecular repertoire-makes fermentation technology a multi- disciplinary
methodology encompassing microbiology, organic
chemistry, biochemistry and molecular biology.
When fermenting volumes larger than 10L, necessarybiosafety measures are taken, especially when Risk
Group 2 (RG2) pathogens are used. These includeBiosafety Level 2 Large Scale (BSL2-LS) containmentfacility design and special operational procedures.
 As these products can be toxic and hazardous, their
recovery and purication require adequate chemical/
biochemical facilities and equipment including isolators
for handling High-Potent APIs (HPAPIs).
Under cGMP fermentation procedures, quality isbuilt into the entire process ensuring that regulatoryagencies requirements are met in terms of safety,
product identity, quality and purity.
Silvian Shama, Ph.D., cGMP Fermentation Development Manager 
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