what is meant by pharming
use of genetic engineering to make therapeutics. Eg
- vaccine antigens
insulin
growth hormones
what are the requirements in mass production
must have
1. clean rooms
2. sterile or virus segregation equipment
3. segregation of personnel
outline the process of mass production
- cell line development
- cell expansion
- cell culture
- harvest
- purification
- virus inactivation or removal
- filling
- finishing
- packaging
- quality assurance
- stability
what are the basic elements of the clean up process
- cell disruption- mechanical, chemical, enzymatic, antibiotic
- removal of insolubles- filtration, centrifugation
- product isolation- removal of less valuable components
- product purification- affinity, size exclusion, crystallisation
- product completion- sterilisation and removal of viruses or depyrogenation
what does human serum albumin need in process chromatography
- flocculation of solids, ionic strength modification and flocculant
- pH modification for selective precipitation of protein fractions
- size exclusion chromatography
- gel permeation chromatography
- ion exchange chromatography
what can biologics be composed of
sugars, proteins, DNA fragments or complex combinations of these substances, or may be living entities such as cells and tissues
give examples of routine biologicals control of quality
- melting point or glass transition- indicates purity, water content
- optical density- indicates particulates, denaturation
what are the 3 categories in control of quality
- biological potency
- in vitro, in vivo, impurity - microbiological science
- pathogens, process indicators, pyrogens - analytical science
- ELISA, electrophoresis, microscopy
what are the problems with biologicals
- consistency of biological material- risk of variability
- uniformity from batch to batch
- non inert growth medium
- potency
what is meant by lean manufacturing within industrial biotechnology
- developed to provide a less wasteful type of production
- commonly uses the following tools: new concepts, just-in-time, value stream mapping, total production maintenance
- helps reduce costs of production of biologicals
what are the risks with lean manufacturing
risks associated with any form of reduced testing or the idea of restricted process monitoring
what is the role of the qualified person on biologicals and quality assurance streams
- directives, guidelines to cGMP/GLP followed
- validation
- checks of production conditions
- MHRA/FDA approval
what is an internal form of regulation
quality assurance and validation
