In a Pharmaceutical Manufacturing article, Tech Transfer: Let’s Take It from the Top, Emerson’s Bob Lenich highlights the importance of a top down approach to technology transfer across the development lifecycle.
Bob opens noting the challenges:
Rapid development of these new compounds into products drives a company’s bottom line. But increasing global regulatory requirements coupled with competition from generics and biosimilars means that successful developments have less and less time as the exclusive offering — where pharmaceutical companies regain the bulk of the return on their development investment.
He cites four core conditions to improve the speed and effectiveness of technology transfer:
- A corporate culture and associated operating environment that supports utilizing common drug manufacturing steps within and across pipeline phases
- Alignment of the standardized manufacturing and reporting steps to be used across each phase
- A clear pipeline management change control mechanism to pass the common manufacturing aspects to the next phase and to ensure that the current standards are used
- Clearly defined strategies for data collection, organization, comparison and analysis
The requirements of researchers at the front end of the discovery process are very different from the commercial manufacturing requirements at the back end of the process. The need for establishing a structured environment is great.
Key individuals involved in technology transfer must successfully hand over critical process parameters and quality attributes, equipment types and characteristics, all the recipe information (steps, sequence, materials, tests, etc.) and all the documented process understanding so that product development will progress successfully in later stages.
Bob notes the importance of executive leadership sponsorship in the effort:
…to both confirm the priority and to resolve conflicts and roadblocks. People driving technology transfer must clearly understand both their own department’s needs as well as the needs of the next stage of development.
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Implementing individual systems geared toward department needs yet designed to work in other stages enables independent phases of the development structure to maintain and customize systems while still allowing for easy transfer, location and auditing across development.
Systems like the DeltaV distributed control system (DCS) and Syncade manufacturing execution system (MES):
…facilitate efficient sharing of manufacturing procedures and data across the development chain. By working with an automation vendor early to define control systems and strategies, organizations can significantly simplify cross-departmental transfer.
Some examples of standardizing on business processes and technologies across the development lifecycle include:
- Reduction of variation in work performance
- Reduction or elimination of errors and mistakes
- Improved, consistent quality
- Established scales and increased capacity for efficient task completion
- Visual management
- Seeing when processes are not operating normally
- Improved reporting, analytics and analysis practices
Read the article for more on establishing these standards, identifying critical quality attributes (CQAs) and critical process parameters (CPPs), decoupling equipment specifics to address the different requirements at each phase of the development process, change management and data management.
You can also connect and interact with other pharmaceutical and biotech industry experts in the Life Sciences group in the Emerson Exchange 365 community.
