PCT’s E&I Center helps clients think beyond current practices and develop long-term solutions to the unique challenges faced by of cell therapy manufacturers.
PCT’s E&I solutions accelerate the use of automation, integration, closed processing and other strategies to address the important issues of scale up, cost of goods, quality control and robustness of their clients’ manufacturing processes in anticipation of commercial success.
PCT is at the forefront of applying ENGINEERING principles to transition cell therapy science to therapeutics. They focus on:
- Beginning with the end in mind: successful commercial-scale manufacturing
- Application of Development by Design (DbD) principles (ICH Q8)
- Application of Risk Management principles (ICH Q9)
- Systems engineering, integration, and automation
- A structured development methodology centered on unit operations
- Current state vs future state process mapping
- Cost of goods modeling
- Quality risk management
- Change management/comparability assessment
PCT raises the bar for INNOVATION by thinking beyond current practice to help reach their clients’ manufacturing goals by considering:
- Buy/Build options:
- Can available technology be applied or adapted?
- Is new technology needed?
- Partnering with technology providers to more effectively bring new solutions to cell therapy
- Considering closed systems, single-use disposables, automation, and integration as key drivers for innovation
Contact PCT to learn how PCT can put its E&I services to work for you.