Cell Culture
Maintain both microbial and mammalian cell cultures as pure cultures during the upstream stages of production
Type
Domain
Competency Area
Production
Levels
Implement aseptic cell culture techniques to maintain cell cultures in a pure state during production
Follow aseptic techniques when working with biological materials
Prepare and examine microbial slides
Perform bacterial Gram stains
Prepare pour-plates and shake-flask cultures
Isolate colonies and maintain pure cultures in accordance with Standard Operating Procedures (SOPs)
Extrapolate plate counts to obtain the correct colony-forming-units (CFUs) in starting samples
Determine growth of suspension cells and anchorage-dependent cells on microcarriers
Conduct plaque assays to verify and maintain viral clearance barriers
Guide cell culture activities and oversee implementation
Select media, materials and equipment for cell culture processes
Define process steps for cell culture maintenance during the upstream stages of production
Align cell culture operations to relevant regulations, codes, guidelines and Quality Assurance (QA) procedures
Communicate performance parameters and propagation targets for cell culture activities
Maintain oversight of cell culture activities
Record speed and yield of cell propagation
Identify and mitigate hazards associated with the samples, preparation methods, reagents and equipment
Advise on optimal cell culture processes, integrating manufacturing demands and other production processes
Integrate cell culture activities with other systems and processes in the biopharmaceuticals manufacturing facilities
Develop internal guidelines and standards for cell culture operations in line with Current Good Manufacturing Practices (CGMPs)
Determine performance parameters for cell cultivation activities
Troubleshoot technical issues in cell culture operations
Assess process performance to identify opportunities for optimisation
Establish processes and mechanisms to manage risks and hazards associated with cell cultures