|Brian Hampson: automation must support a clear vision for commercially viable manufacturing|
By Brian Caine
“Companies must understand that automation should support a clear vision for commercially viable manufacturing and is a tactical approach to support a strategic end,” Brian Hampson ME, vice president of manufacturing development and engineering at PCT, a Caladrius company, told attendees at Cell Therapy Bioprocessing & Commercialization.
Hampson has more than 20 years’ experience in the cell therapy industry and has first-hand experience in the evolution and progress being made within the cell therapy development process. He said that “automation strategies vary with fundamental differences of product”, pointing out several factors need to be considered including:
- Development by design, as defined by quality – COGS – scale and sustainability
- Should consider needle-to-needle scope
- Managing comparability risk
- Automation must be part of a comprehensive strategy
- Automation considerations:
He also pointed out the many types of automation to consider:
- Process automation (closed-loop process control)
- Task automation
- Test automation
- Factory automation
- Information: electronic batch records
- Execution: manufacturing execution system (MES)
He stressed that “automation must be planned in the context of opportunity and value”. “We all talk about doing everything early, but automation can have a dark side to it,” he said. “You need to be sure what is going on inside the process.”
He warned that automation can also create its own problems, including process black box effect, supply chain risk, complexity, cash and timeline sink, comparability risk and unmitigated automation failure.
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