96135 Biotech Manufacturing6cp; standard mode: 3hpw (on campus workshop); distance mode: offered online, requiring no on-campus attendance
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Biotech manufacturing is one of the fastest growing technologies, driven by the pursuit of pharmaceutical companies to look for new and novel approaches to fight disease states, many of which have no known treatments or cures. Biotech manufacturing differs from traditional pharmaceutical manufacturing in the following ways:
- The end products are large molecules and manufactured in small batch sizes, as opposed to small molecule large batch size
- The use of recombinant technology versus traditional chemical synthesis of APIs.
- There is an upstream (cell fermentation) stage followed by a downstream (cell harvest and purification) stage
- Manufacturing equipment is often a combination of single-use, made from polymers, and multiple use stainless steel vessels and pipework, as opposed to stainless steel only.
- There is a need to select and characterise an appropriate Master Cell Bank (MCB) and Working Cell Bank (WCB) as the starting material
- There is a need to apply biological analytical methods
- Lyophilisation and aseptic filling versus terminal sterilization
Knowledge and understanding of these manufacturing operations is critical for students to have a well-rounded education in the area of therapeutic formulation and manufacturing. This subject addresses all of the seven points unique to biotech manufacturing, described in the bullet points above.
Many students will be working in Pharmaceutical Companies. This will allow students to view important activities routinely carried out in cleanroom environments. The activities are:
- Gowning and de-gowning using cleanroom garments
- Reading and recording pressure differentials between each cleanroom
- Environmental monitoring (including particle counting) of the cleanroom environment
- Sampling of the WFI and/or Purified Water
For those students who are not currently working in the industry, this course will access videos, literature and other media to provide this knowledge.
Detailed subject description.