Cell Culture

Maintain both microbial and mammalian cell cultures as pure cultures during the upstream stages of production



Competency Area



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